IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 12/14/2025 | OLZ |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | 12/12/2025 | NUC |
| K252681 | EnCor EnCompass™ Breast Biopsy And Tissue Removal System |
Bard Peripheral Vascular, Inc. |
12/12/2025 | KNW |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) |
Bio Compression Systems, Inc. |
12/12/2025 | JOW |
| K252391 | Revi System | Bluewind Medical , Ltd. | 12/12/2025 | QXM |
| K242817 | Jason Membrane | Botiss Biomaterials GmbH | 12/12/2025 | NPL |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) |
Breast-Med, Inc. | 12/12/2025 | NEU |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 12/12/2025 | QSY |
| K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda |
12/12/2025 | NHN |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR And Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) |
Eurosets Srl | 12/12/2025 | DTZ |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe With Needle; EXEL Disposable Syringe With Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle |
Exelint International, Co. |
12/12/2025 | |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US |
FUJIFILM Corporation | 12/12/2025 | EOQ |
| K251177 | Self-Seal Sterilization Pouch And Roll |
Guangdong Maidi Medical Co., Ltd. |
12/12/2025 | FRG |
| K253489 | Swoop® Portable MR Imaging® System |
Hyperfine, Inc. | 12/12/2025 | LNH |
| K251085 | Ihealth Flu A&B/COVID-19/RSV Rapid Test; Ihealth Flu A&B/COVID-19/RSV Rapid Test Pro |
Ihealth Labs, Inc. | 12/12/2025 | SCA |
| K251092 | Ihealth Flu A&B/COVID-19 Rapid Test; Ihealth Flu A&B/COVID-19 Rapid Test Pro |
Ihealth Labs, Inc. | 12/12/2025 | SCA |
| K252090 | Pterygoid Indication For GM Helix Implants |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
12/12/2025 | DZE |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2 .5/Novo-R-0.60-1.8/Novo-R-0.40 -1.8) |
Micro-Energy Medical Technology Co., Ltd. |
12/12/2025 | GEX |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) |
Remidio Innovative Solutions Private Limited |
12/12/2025 | HKI |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement |
Rizhao Huge Biomaterials Company, Ltd. |
12/12/2025 | EMA |
| K250847 | VaporShield | Vault Paragon Group, Inc. |
12/12/2025 | MEG |
| K253749 | Affixus® Natural Nail® Proximal Humeral System |
Zimmer Switzerland Manufacturing GmbH |
12/12/2025 | HSB |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) |
4Web Medical, Inc. | 12/11/2025 | OVE |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista |
A Plus Biotechnology Co., Ltd. |
12/11/2025 | HRS |
| K252997 | HyperFlex® Bunion Correction System |
Hyperflex Medical | 12/11/2025 | HRS |
| K250988 | KLS Martin Pure Pectus System | Kls- Martin L.P. | 12/11/2025 | HRS |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 12/11/2025 | QFM |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 12/11/2025 | DQK |
| K251883 | MIM – LesionID Pro | Mim Software, Inc. | 12/11/2025 | LLZ |
| K252941 | HALYARD* Adult Face Mask With SO SOFT* Lining And SO SOFT* Earloops |
O&M Halyard, Inc. | 12/11/2025 | FXX |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 12/11/2025 | HCG |
| K251598 | Intellidrop | Brainspace, Inc. | 12/10/2025 | JXG |
| K252497 | SANSA HSAT | Huxley Medical | 12/10/2025 | MNR |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 12/10/2025 | HSB |
| K250192 | Verisafe Safety Retractable Insulin Syringes |
Promisemed Hangzhou Meditech Co., Ltd. |
12/10/2025 | FMF |
| K252343 | Atlantis® Abutments In Titanium |
Dentsply Sirona | 12/09/2025 | NHA |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) |
Devilbiss Healthcare, LLC |
12/09/2025 | CAW |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 12/09/2025 | GEH |
| K251199 | Allia Moveo | Ge Medical Systems Scs | 12/09/2025 | OWB |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, And LGT-2320SP) |
Guangzhou Longest Medical Technology Co., Ltd. |
12/09/2025 | NGX |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. |
12/09/2025 | QKQ |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 12/09/2025 | EMA |
| K253706 | Lancing Device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. |
12/09/2025 | QRL |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | 12/08/2025 | POK |
| K251936 | Ceribell Delirium Monitor System |
Ceribell, Inc. | 12/08/2025 | NCG |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System |
Degen Medical | 12/08/2025 | OVD |
| K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. |
12/08/2025 | ITI |
| K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) |
Guangdong Ace-Tec Co., Ltd. |
12/08/2025 | OHS |
| K250258 | HeartBeam AIMIGo With 12-L ECG Synthesis Software System |
Heartbeam, Inc. | 12/08/2025 | DXH |
| K250190 | Sequential Compression System (SCD600) |
Shenzhen Comen Medical Instruments Co.,Ltd |
12/08/2025 | JOW |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. |
12/08/2025 | EIH |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) |
KARL STORZ SE & CO. KG | 12/05/2025 | EOQ |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 Μg) GEP10 |
Thermo Fisher Scientific (Oxoid Ltd.) |
12/05/2025 | JTN |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 12/05/2025 | PBF |
| K252504 | Gastric Alimetry | Alimetry , Ltd. | 12/05/2025 | MYE |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT) |
Blue Belt Technologies, Inc. |
12/05/2025 | OLO |
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) |
Dornier Medtech America Inc (Dmta) |
12/05/2025 | FAS |
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) |
Epic Medical Pte. , Ltd. | 12/05/2025 | ONB |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | 12/05/2025 | DXH |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
12/05/2025 | IOR |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
12/05/2025 | IOR |
| K250764 | SpineLinc Anterior Cervical Implant System |
Lincotek Medical | 12/05/2025 | ODP |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. |
12/05/2025 | QKB |
| K252465 | Any-Core | Mediclus Co., Ltd. | 12/05/2025 | EBF |
| K252605 | Mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) |
Medspira, LLC | 12/05/2025 | FFX |
| K252494 | Electrically Powered Wheelchair (KZ301B) |
Nanjing Kangni Smart Technology Co., Ltd. |
12/05/2025 | ITI |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. |
12/05/2025 | NPL |
| K252296 | OncoPatch | Oncopatch, Inc. | 12/05/2025 | KXK |
| K251514 | Overjet CBCT Assist | Overjet, Inc. | 12/05/2025 | QIH |
| K253868 | QuietLab Pro | QuietLab, LLC | 12/05/2025 | LRK |
| K250743 | Remvia NightGuard | Remvia | 12/05/2025 | MQC |
| K251657 | Personalized Therapy Comfort Settings (PTCS) |
Resmed Corp. | 12/05/2025 | BZD |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 12/05/2025 | LPH |
| K252151 | Els Unibond | Saremco Dental AG | 12/05/2025 | KLE |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) |
Shenzhen Siken 3D Technology Development Co., Ltd. |
12/05/2025 | OHS |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s /E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) |
Sonoscape Medical Corp | 12/05/2025 | IYN |
| K250795 | PUREVUE™ FMS | W.O.M. World OF Medicine GmbH |
12/05/2025 | HRX |
| K250679 | FFX Facet Fixation System | Sc Medica | 12/04/2025 | MRW |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) |
Siemens Healthcare Diagnostics, Inc. |
12/04/2025 | JNL |
| K250791 | ASUS Ultrasound Imaging System (LU800 Series) |
Asustek Computer, Inc. | 12/04/2025 | IYN |
| K252126 | MitraPatch Mitral Valve Repair System |
Chawla Heart Technologies, LLC |
12/04/2025 | PAW |
| K251257 | Nset+ Stabilization Set [6426733]; Nset+ Stabilization Set With Nsyte Needle Free Connector (NFC) [6426731]; Nsyte Needle Free Connector (NFC) [6426727] |
Np Medical | 12/04/2025 | FPA |
| K251943 | Spineology Navigation Instruments |
Spineology, Inc. | 12/04/2025 | OLO |
| K252596 | Tigon Medical Knotless And Dual Javelin All-Suture Anchors |
Tigon Medical | 12/04/2025 | MBI |
| K252429 | Vektor Computational ECG Mapping System (vMap®) |
Vektor Medical, Inc. | 12/04/2025 | DQK |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. |
12/04/2025 | INI |
| K251779 | Omnipod 5 Algorithm | Insulet Corporation | 12/03/2025 | QJI |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. |
12/03/2025 | QJP |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co.,Ltd | 12/03/2025 | OEB |
| K250725 | Hugo™ RAS System | Covidien, LLC | 12/03/2025 | SCV |
| K251881 | HippoMind (v1.0) | Hippoclinic | 12/03/2025 | OLT |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
12/03/2025 | IYN |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 12/03/2025 | DSH |
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 12/03/2025 | JAD |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) |
Yadu Medical (Henan) Co., Ltd. |
12/03/2025 | FYA |
| K250896 | Aura Wave | Aura Wellness, LLC | 12/02/2025 | SGT |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe |
Becton, Dickinson and Company |
12/02/2025 | NGT |
| K252021 | Disposable Endoscopic Injection Needles |
Changzhou New Med Micro-Medtech Co., Ltd. |
12/02/2025 | FBK |
| K252069 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 12/02/2025 | NAY |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
Mighty Oak Medical | 12/02/2025 | |
| K252827 | IBP Cable Becton Dickinson (2606488); IBP Cable Edwards (2606489); IBP Cable Abbott, Medex (2606490); IBP Cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) |
Drägerwerk AG & Co KGaA | 12/01/2025 | DSA |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 |
Canon Medical Systems Corporation |
12/01/2025 | KPS |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants |
Exactech, Inc. | 12/01/2025 | KWT |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) |
Shenzhen Suyzeko Limited. |
12/01/2025 | OLI |
| K253250 | Minuteman® G6 MIS Fusion Plate |
Spinal Simplicity, LLC | 12/01/2025 | PEK |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) |
Unimed Medical Supplies, Inc. |
12/01/2025 | DQA |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series And -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series And -29 Series) (U410-29) |
Unimed Medical Supplies, Inc. |
12/01/2025 | DQA |
| K252658 | Medical Diode Laser Systems (TR-B) |
Baoding Te'Anzhou Electronic Technology Co., Ltd. |
11/28/2025 | GEX |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. |
11/28/2025 | JAK |
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | 11/28/2025 | QDG |
| K250636 | Sophy Mini Monopressure Valve (SM1) |
Sophysa | 11/28/2025 | JXG |
| K252760 | Carriere® Motion Pro® Clear Bite Corrector |
Ortho Organizers, Inc. | 11/27/2025 | DYW |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip |
Acon Laboratories, Inc. | 11/26/2025 | GTY |
| K251674 | Fenom Flo™ FeNO Monitoring System |
Mgc Diagnostics Corporation |
11/26/2025 | MXA |
| K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 11/26/2025 | MOF |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 11/26/2025 | NHA |
| K252388 | Vanquish Water Vapor Ablation Device |
Francis Medical, Inc. | 11/26/2025 | KNS |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. |
11/26/2025 | OXO |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. |
11/26/2025 | LKF |
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection And Transport Device |
Medical Wire & Equipment Company (Bath), Ltd. |
11/26/2025 | JSM |
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing |
Sb-Kawasumi Laboratories, Inc. |
11/26/2025 | PTI |
| K252000 | Udr Arria & Udr Aris | Shanghai United Imaging Healthcare Co., Ltd. |
11/26/2025 | KPR |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter |
Surgical Instrument Service and Savings, Inc. |
11/26/2025 | NLH |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer |
Truvian Health | 11/26/2025 | CGX |
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited |
11/25/2025 | PMC |
| K253344 | BELLUS-Q | Speclipse., Inc. | 11/25/2025 | GEX |
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. |
11/25/2025 | GEX |
| K251798 | RCT700 | Ray Co., Ltd. | 11/25/2025 | OAS |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) |
Olympus Medical Systems Corporation |
11/25/2025 | KNS |
| K251550 | NX01 (NX01) | Naox Technologies Sas | 11/25/2025 | OMC |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | 11/25/2025 | QAS |
| K252555 | Medusa Orthopedics Boa External Fixation System |
Medusa Orthopedics, LLC | 11/25/2025 | KTT |
| K253365 | LuxCreo Flexible Partial Denture Resin |
Luxcreo, Inc. | 11/25/2025 | EBI |
| K252762 | HALO AP Dx | Indica Labs, LLC | 11/25/2025 | QKQ |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | 11/25/2025 | LRK |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® |
Geistlich Pharma AG | 11/25/2025 | NPL |
| K250635 | FEops HEARTguide Simulation Application |
Feops NV | 11/25/2025 | QQI |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) |
Esaote, S.P.A. | 11/25/2025 | IYN |
| K252004 | Encore Night Guard | Encore Guards | 11/25/2025 | OBR |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) |
Dongguan Lide Electric Appliance Co., Ltd. |
11/25/2025 | OHT |
| K251070 | Akura Thrombectomy System | Akura Medical | 11/25/2025 | QEW |
| K251401 | PennPET Explorer Positron Emission Tomograph |
Trustees OF The University OF Pennsylvania |
11/25/2025 | KPS |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | 11/25/2025 | HGX |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 11/25/2025 | MAX |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
11/24/2025 | GEX |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
11/24/2025 | GEX |
| K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | 11/24/2025 | QEX |
| K250769 | Dakota LP System | Precision Spine, Inc. | 11/24/2025 | ODP |
| K251631 | The BAG Manual Resuscitator And Accessories |
Laerdal Medical AS | 11/24/2025 | BTM |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 |
Ge Medical Systems Ultrasound and Primary Care Diagnostics |
11/24/2025 | IYN |
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC |
11/24/2025 | DSB |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) |
F Care Systems USA, LLC | 11/24/2025 | GEI |
| K242503 | Trilly Pediatric Oxygenator With Integrated Arterial Filter (US5232) |
Eurosets Srl | 11/24/2025 | DTZ |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) |
Bozhou Rongjian Medical Appliance Co., Ltd. |
11/24/2025 | NUH |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 |
AngioDynamics, Inc. | 11/24/2025 | QEZ |
| K252366 | A2z-unified-triage | A2z Radiology Ai, Inc. | 11/24/2025 | QAS |
| K250927 | KARL STORZ Cholangiography Set | KARL STORZ SE & CO. KG | 11/22/2025 | GCJ |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. |
11/21/2025 | CAW |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 |
Everyway Medical Instruments Co.,Ltd |
11/21/2025 | NUH |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages |
Effortmed, LLC | 11/21/2025 | ODP |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits And White Foam Accessory |
Deroyal Industries, Inc. | 11/21/2025 | OMP |
| K251205 | Atlantis® Abutments In Titanium For Straumann BLX And Neodent GM Implants |
Dentsply Sirona | 11/21/2025 | NHA |
| K252070 | Ceribell Infant Seizure Detection Software |
Ceribell, Inc. | 11/21/2025 | OMB |
| K250714 | FluoroDose Varnish | Centrix, Inc. | 11/21/2025 | LBH |
| K251293 | CardioVision | Icardio.Ai | 11/21/2025 | QUO |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC |
11/21/2025 | HRX |
| K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 11/21/2025 | |
| K252696 | LEGACY | Phasor Health, LLC | 11/21/2025 | HBG |
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) |
Staclear, Inc. | 11/21/2025 | QLY |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 11/21/2025 | FMI |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) |
Suzhou Master Machinery Manufacturing Co.,Ltd |
11/21/2025 | IOR |
| K250560 | BEE HA | Ngmedical GmbH | 11/21/2025 | ODP |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) |
Intradin (Shanghai) Machinery Co., Ltd. |
11/21/2025 | INI |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 11/21/2025 | LLZ |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) |
Graphy, Inc. | 11/21/2025 | EBI |
| K253495 | Syngo.mr Applications (VB80) | Siemens Healthineers AG | 11/20/2025 | LLZ |
| K251365 | OptumSI Implant System | Si Solutions, LLC | 11/20/2025 | OUR |
| K252625 | The Response Ortho Smart Fixator - Hexapod System |
Response Ortho Solutions, LLC |
11/20/2025 | KTT |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) |
Remington Medical, Inc. | 11/20/2025 | DPW |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. |
11/20/2025 | MRW |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) |
Integrated Endoscopy, Inc. |
11/20/2025 | GCJ |
| K250643 | Disposable Polymer Ligation Clips |
Hangzhou Kangji Medical Instrument Co., Ltd. |
11/20/2025 | FZP |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
11/20/2025 | GEX |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory |
11/20/2025 | MUJ |
| K253123 | CuRAS Hybrid | Classys, Inc. | 11/20/2025 | GEX |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star |
Siemens Shenzhen Magnetic Resonance , Ltd. |
11/20/2025 | LNH |
| K243753 | Cobas Liat Bordetella Panel Nucleic Acid Test |
Roche Molecular Systems, Inc. |
11/20/2025 | OZZ |
| K253070 | Namic Radial Arm Band, 23 Cm (DYNJRADBAND); Namic Radial Arm Band, 26 Cm (DYNJRADBANDL) |
Medline Industries, LP | 11/20/2025 | DXC |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) |
Hardy Diagnostics | 11/20/2025 | JTN |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. |
11/20/2025 | EBI |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | 11/19/2025 | JAQ |
| K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) |
Sunglor Technology Co., Ltd. |
11/19/2025 | OHS |
| K242603 | MyPAO SA Guides | Medacta International S.A. |
11/19/2025 | PBF |
| K250642 | LUOFUCON® Skin And Wound Cleanser (Spray, Mist, Squeeze, Bottle.) |
Huizhou Foryou Medical Devices Co, Ltd. |
11/19/2025 | FRO |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | 11/19/2025 | HRS |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun |
Fisher &Paykel Healthcare , Ltd. |
11/19/2025 | SGR |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors |
Depuy Ireland UC | 11/19/2025 | JWH |
| K252642 | Microcurrent Facial Device (CEC101, EEI101) |
Shenzhen Dachi Communication Co., Ltd. |
11/19/2025 | OHS |
| K253035 | IPL Hair Removal Device (SYL001AZ, SYL002AZ) |
Gu'An Yeolight Smart Electronics Co., Ltd. |
11/19/2025 | OHT |
| K251910 | Focal One® | Edap Technomed, Inc. | 11/19/2025 | PLP |
| K250912 | IntelliSep Test | Cytovale, Inc. | 11/19/2025 | QUT |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) |
Unimed Medical Supplies, Inc. |
11/18/2025 | DQA |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) |
Unimed Medical Supplies, Inc. |
11/18/2025 | DQA |
| K252636 | Fluido Compact System | The Surgical Company International B.V. |
11/18/2025 | LGZ |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom |
Suretex Limited | 11/18/2025 | HIS |
| K252582 | Inclusive® Titanium Abutments Compatible With: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems |
Prismatik Dentalcraft, Inc. |
11/18/2025 | NHA |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. |
11/18/2025 | HRS |
| K253411 | Miniature Telescope For Urology (27033AA) |
KARL STORZ SE & CO. KG | 11/18/2025 | FGB |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx |
Guangzhou Wondfo Biotech Co., Ltd. |
11/18/2025 | NFT |
| K252729 | Universal Spinal System | Double Medical Technology, Inc. |
11/18/2025 | NKB |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 11/18/2025 | QRX |
| K251191 | Collagen Dura Regeneration Membrane - Repair |
Collagen Matrix, Inc. | 11/18/2025 | GXQ |
| K243981 | Hexoskin Medical System (7100-00016) |
Carre Technologies, Inc. | 11/18/2025 | DXH |
| K252281 | Ulricheasyinject Max 2M (XD 10140); Ulricheasyinject Max 3 (XD 10150); Ulricheasyinject Max 3 (XD 10180) |
Ulrich GmbH & Co. KG | 11/18/2025 | IZQ |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 11/17/2025 | GEI |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV |
11/17/2025 | MYN |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile Tested For Use With Chemotherapy Drugs And Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-sterile Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Mercator Medical (Thailand), Ltd. |
11/17/2025 | LZA |
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | 11/17/2025 | LFX |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
11/17/2025 | IYN |
| K252792 | PM2™ System With ECGuide™ Connector |
Piccolo Medical, Inc. | 11/17/2025 | LJS |
| K252330 | DeepRESP | Nox Medical Ehf | 11/17/2025 | OLZ |
| K250501 | System Sophi | This AG | 11/14/2025 | HQC |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. |
11/14/2025 | CAF |
| K251538 | Status™ COVID-19/Flu A&B | Princeton Biomeditech Corp |
11/14/2025 | SCA |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 11/14/2025 | MYN |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC |
11/14/2025 | KCT |
| K251821 | ARC-EX System | Onward Medical, Inc. | 11/14/2025 | SDO |
| K250865 | KLS Martin IPS Forearm System | Kls- Martin L.P. | 11/14/2025 | HRS |
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | 11/14/2025 | LSR |
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC |
11/14/2025 | FIP |
| K251078 | AutoDensity | Eos Imaging | 11/14/2025 | QIH |
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited |
11/14/2025 | FRF |
| K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) |
Alovea Healthcare Co. , Ltd. |
11/14/2025 | OHT |
| K252592 | TELLTALE Electrosurgical Guidewire System |
Telltale, LLC | 11/13/2025 | SGO |
| K252949 | Geminus Volar Distal Radius Plating System |
Skeletal Dynamics, Inc. | 11/13/2025 | HRS |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) |
Shenzhen Future Electronic Co., Ltd. |
11/13/2025 | IRP |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS |
11/13/2025 | OLO |
| K251842 | Dental Computed Tomography X-ray System |
Fussen Technology Co., Ltd. |
11/13/2025 | OAS |
| K252308 | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | 11/13/2025 | OHS |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
11/13/2025 | IYN |
| K252829 | Powered Wheelchair (PL001-9001) |
Suzhou KD Intelligent Device Co., Ltd. |
11/12/2025 | ITI |
| K253290 | XSTAT P15 | Revmedx, Inc. | 11/12/2025 | PGZ |
| K252452 | PeekMed Web | Peek Health, S.A. | 11/12/2025 | QIH |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) |
Olympus Medical Systems Corp. |
11/12/2025 | OWN |
| K252959 | WRISTAR MultiAx Distal Radius Kit |
Intrauma S.P.A | 11/12/2025 | HRS |
| K252271 | Hemoclip | Hangzhou Ags Medtech Co., Ltd. |
11/12/2025 | PKL |
| K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture |
Ethicon, Inc. | 11/12/2025 | NEW |
| K251833 | EMPOWR Acetabular® Liner Extension |
Encore Medical, LP | 11/12/2025 | LPH |
| K243715 | Synthes Patient Specific Implants |
Synthes GmbH | 11/12/2025 | GXN |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments |
Icotec AG | 11/12/2025 | NKG |
| K252474 | Withings BeamO (SCT02) | Withings | 11/10/2025 | DPS |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | 11/10/2025 | NRY |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | 11/10/2025 | MUH |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE |
Kls- Martin L.P. | 11/10/2025 | GXN |
| K252560 | Atlas Spine HiRISE™ Expandable Cervical Corpectomy System |
Atlas Spine, Inc. | 11/10/2025 | PLR |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) |
Philips Medizin Systeme Böblingen GmbH |
11/10/2025 | MHX |
| K252287 | Symani Surgical System | Medical Microinstruments, Inc. |
11/10/2025 | SAQ |
| K251596 | Lunderquist Extra Stiff Wire Guide |
William Cook Europe Aps | 11/09/2025 | DQX |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA |
Topcon Corporation | 11/07/2025 | HKX |
| K243131 | Triathlon Pro | Sigma Biomedical | 11/07/2025 | NUH |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
11/07/2025 | IYN |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M) |
Rollz International BV | 11/07/2025 | ITI |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite |
Premier Dental Products Company |
11/07/2025 | EBF |
| K252519 | CO2 Laser Therapy System (K106) |
Hebei Keylaser Sci-Tech Co.,Ltd |
11/07/2025 | GEX |
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | 11/07/2025 | OBP |
| K250264 | SugarBug (1.x) | Bench7, Inc. | 11/07/2025 | MYN |
| K252564 | Medical Diode Laser Systems (VeinCure) |
Baoding Te'Anzhou Electronic Technology Co., Ltd. |
11/07/2025 | GEX |
| K251295 | Ulrichinject CT Motion (XD 8000) |
Ulrich GmbH & Co. KG | 11/07/2025 | IZQ |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System |
S.I.N. Implant System Ltda |
11/07/2025 | DZE |
| K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | 11/07/2025 | QWO |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | 11/07/2025 | NXC |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System |
Inion Oy | 11/07/2025 | JEY |
| K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 11/06/2025 | GEI |
| K253074 | Tandem Mobi Insulin Pump With Interoperable Technology |
Tandem Diabetes Care, Inc. |
11/06/2025 | QFG |
| K251792 | Stereotaxis GenesisX RMN With Navigant ™ Workstation (NWS) |
Stereotaxis, Inc. | 11/06/2025 | DXX |
| K251555 | Ultra™ Compression Screw System |
Pace Surgical | 11/06/2025 | HWC |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) |
Hefei Chimed Intelligent Machine Co., Ltd. |
11/06/2025 | OXO |
| K252515 | Q-Switched Nd:Yag Laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd |
11/06/2025 | GEX |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA |
Dmp Dental Industry S.A. | 11/06/2025 | KLE |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. |
11/06/2025 | KWS |
| K252525 | AIO Breathe | Aiomega, LLC | 11/06/2025 | LRK |
| K253265 | BriefCase-Triage | Aidoc Medical , Ltd. | 11/06/2025 | QAS |
| K252133 | Adaptix Ortho350 | Adaptix Limited | 11/06/2025 | IZF |
| K253478 | Motive™ Muscle Stimulator For Lower Back (OT01-1003) |
Motive Health, Inc. | 11/06/2025 | NGX |
| K250423 | Mb-fix Cranial Stabilization Systems |
Medical Bees GmbH | 11/06/2025 | HBL |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | 11/06/2025 | HBE |
| K250376 | ViVY | Viatherm Therapeutics, LLC |
11/05/2025 | IMJ |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | 11/05/2025 | FOZ |
| K252514 | EVAC-MRI | Phasor Health, LLC | 11/05/2025 | JXG |
| K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 11/05/2025 | OLO |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept |
Beijing Sinovation Medical Technology Co., Ltd. |
11/05/2025 | GZL |
| K250375 | Allure Hip Stem And Intramedullary Plugs |
Waldemar Link GmbH & CO KG |
11/05/2025 | MEH |
| K251410 | VXvue | Vieworks Co., Ltd. | 11/04/2025 | LLZ |
| K252964 | PRIMED Surgical And Procedure Masks |
Primed Medical Products, Inc. |
11/04/2025 | FXX |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. |
11/04/2025 | FMF |
| K251303 | Tamburo Thulium Fiber Laser System |
Menovex Medical Technology (Shenzhen) Co., Ltd. |
11/04/2025 | GEX |
| K251709 | MedCAD® AccuStride™ System | Medcad | 11/04/2025 | PBF |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) |
Karma Mobility Co, Ltd. | 11/04/2025 | IOR |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. |
11/04/2025 | MBI |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) |
Applied Medical Resources Corp. |
11/04/2025 | GEI |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. |
11/04/2025 | OWB |
| K252458 | Kyphoplasty Balloon Dilatation Catheters |
Shanghai Lange Medtech Co., Ltd. |
11/03/2025 | HRX |
| K250330 | 3mensio Workstation | Pie Medical Imaging BV | 11/03/2025 | QIH |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 11/03/2025 | LRK |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
Mighty Oak Medical | 11/03/2025 | LLZ |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 11/03/2025 | EIA |
| K253448 | Sonosite MT Ultrasound System | Fujifilm Sonosite, Inc. | 11/03/2025 | IYN |
| K252484 | Cobas HCV | Roche Molecular Systems, Inc. |
11/03/2025 | MZP |
| K252481 | Cobas CMV | Roche Molecular Systems, Inc. |
11/03/2025 | PAB |
| K252671 | Electric Wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. |
11/03/2025 | ITI |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) |
Zap Surgical Systems, Inc. |
11/03/2025 | IYE |
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 |
Actuated Medical, Inc. | 10/31/2025 | FDS |
| K252442 | Kii Structural Balloon Access System |
Applied Medical Resources Corp. |
10/31/2025 | GCJ |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) |
Applied Medical Resources Corporation |
10/31/2025 | GEI |
| K250358 | BD Enteric Bacterial Panel For BD COR System, BD Enteric Bacterial Panel Plus For BD COR System, And Enteric Bacterial Panel Diluent For BD COR System |
Becton, Dickinson And Company |
10/31/2025 | PCI |
| K252074 | Aplio I900, Aplio I800 And Aplio I700 Software V9.0 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
10/31/2025 | IYN |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) |
Ceribell, Inc. | 10/31/2025 | GXY |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) |
Maxx Orthopedics, Inc. | 10/31/2025 | MBH |
| K250338 | MSS - Humeral Reverse Liners Extension |
Medacta International S .A. |
10/31/2025 | PHX |
| K252088 | Firebird SI Navigation System | Orthofix Us, LLC | 10/31/2025 | OLO |
| K252160 | Persyst 15 EEG Review And Analysis Software (Persyst 15 (P15)) |
Persyst Development, LLC | 10/31/2025 | OMB |
| K252060 | GREEN | Phasor Health, LLC | 10/31/2025 | HBE |
| K250306 | Chex-All Sterilization Pouches And Tubes |
Propper Manufacturing Co., Inc. |
10/31/2025 | FRG |
| K252427 | Diode Laser Hair Removal Machine (GLD01) |
Sanhe Meditech Co.,Ltd | 10/31/2025 | GEX |
| K250917 | Flexible Ureterorenoscope System (Electronic Endoscope Image Processor, Model: SP-TXCLQ12.1, Flexible Ureterorenoscope, Model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) |
Shenzhen Sanping Image Technology Co., Ltd. |
10/31/2025 | FGB |
| K251547 | DESS Dental Smart Solutions | Terrats Medical Sl | 10/31/2025 | NHA |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); |
Vigodent Indústria E Comercio Ltda |
10/31/2025 | ELW |
| K250632 | Arctx Cool Catheter Set | Arctx Medical | 10/30/2025 | PLA |
| K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) |
Boston Scientific Corporation |
10/30/2025 | GEX |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 10/30/2025 | FPA |
| K252430 | Freeprint® Denture Flex | Detax Gmbh | 10/30/2025 | EBI |
| K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) |
Diasorin Molecular, LLC | 10/30/2025 | QOF |
| K252607 | AllTest Urinary Tract Infection Test |
Hangzhou Alltest Biotech Co., Ltd. |
10/30/2025 | JMT |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | 10/30/2025 | NRY |
| K253327 | HANAROSTENT Esophagus Upper (CCC) |
M.I. Tech Co., Ltd. | 10/30/2025 | ESW |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 |
Merchsource, LLC | 10/30/2025 | IRP |
| K251938 | GEN5 And GEN5+ Dental Implant System |
Paragon Implant Mfg., LLC |
10/30/2025 | DZE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
10/30/2025 | OAP |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent |
Taewoong Medical Co., Ltd. |
10/30/2025 | ESW |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) |
Tornier, Inc. | 10/30/2025 | KWT |
| K250337 | AiORTA - Plan | Vitaa Medical Solutions, Inc. |
10/30/2025 | QIH |
| K252752 | Ellacor System With Micro-Coring Technology |
Cytrellis Biosystems, Inc. |
10/30/2025 | QAI |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) |
Boston Scientific Corporation |
10/30/2025 | KRD |
| K253232 | Seguin Annuloplasty Ring | Abbott, Medical | 10/29/2025 | KRH |
| K253345 | JARVIS Diaphyseal Stem Standard |
Fh Industrie | 10/29/2025 | PHX |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 |
Fissiontech, LLC | 10/29/2025 | LRK |
| K251963 | LOGIQ E10s | Ge Medical Systems Ultrasound And Primary Care Diagnostics |
10/29/2025 | IYN |
| K251985 | LOGIQ E10 | Ge Medical Systems Ultrasound And Primary Care Diagnostics |
10/29/2025 | IYN |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. |
10/29/2025 | GCJ |
| K250882 | SANSA HSAT | Huxley Medical | 10/29/2025 | MNR |
| K253323 | Protrieve Sheath | Inari Medical | 10/29/2025 | QEW |
| K253314 | Freedom Infinia™ Total Knee System |
Maxx Orthopedics, Inc. | 10/29/2025 | JWH |
| K252390 | Telescope Guide Extension Catheter |
Medtronic, Ireland | 10/29/2025 | DQY |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System |
Meduloc, LLC | 10/29/2025 | JDW |
| K251772 | Navilas Laser System 577sl (156691) |
Od-Os Gmbh | 10/29/2025 | HQF |
| K252393 | VITROS Immunodiagnostic Products Hs Troponin I Reagent Pack |
Ortho-Clinical Diagnostics, Inc. |
10/29/2025 | MMI |
| K253242 | LCD Monitor (C1216W, C822W, C821W) |
Shenzhen Beacon Display Technology Co., Ltd. |
10/29/2025 | PGY |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) |
Shenzhen Root Innovation Technology Co., Ltd. |
10/29/2025 | HGX |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 |
Smith & Nephew, Inc. | 10/29/2025 | KWS |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) |
Su-Ko Technologies, LLC | 10/29/2025 | QAI |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) |
10/29/2025 | HTN |
| K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | 10/29/2025 | NFO |
| K252314 | Arthrex SutureTak Suture Anchor |
Arthrex, Inc. | 10/29/2025 | MBI |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator And PrecisePath™ Footswitch |
Baylis Medical Technologies, Inc. |
10/28/2025 | GEI |
| K253300 | Fine Osteotomy™ | Bodycad Laboratories, Inc. |
10/28/2025 | HRS |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 10/28/2025 | MAX |
| K252376 | Yomi S Robotic System | Neocis, Inc. | 10/28/2025 | PLV |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 10/28/2025 | EMA |
| K252742 | Navigated Instruments | Tyber Medical, LLC | 10/28/2025 | OLO |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter |
Volcano Corporation (Dba Philips Image Guided Therapy Device |
10/28/2025 | OBJ |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf Garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf Garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf Garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh Garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh Garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh Garment (L)); VenAir, Sequential Compr |
Wellell, Inc. | 10/28/2025 | JOW |
| K252547 | TheraSphere 360™ Y-90 Management Platform |
Boston Scientific Corporation |
10/28/2025 | LLZ |
| K251875 | LifeScale Gram Negative Kit (LSGN) With The LifeScale AST System |
Affinity Biosensors, LLC | 10/27/2025 | SAN |
| K251027 | Cvi42 Coronary Plaque Software Application |
Circle Cardiovascular Imaging, Inc. |
10/27/2025 | QIH |
| K252629 | Electric Breast Pump (HL-3058, F5112) |
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. |
10/27/2025 | HGX |
| K252630 | Electric Breast Pump (HL-3060, F5113) |
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. |
10/27/2025 | HGX |
| K250520 | OsteoCentric Navigated Instruments System |
Osteocentric Technologies, Inc. |
10/27/2025 | OLO |
| K251824 | Patriot Duo | Patriot Laser, LLC | 10/27/2025 | GEX |
| K251331 | Blood Pressure Monitor (B73, BE23T) |
Shenzhen Jamr Technology Co., Ltd. |
10/27/2025 | DXN |
| K250297 | TECHFIT Patient-Specific Cranial System |
Techfit Digital Surgery, Inc. |
10/27/2025 | GWO |
| K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) |
Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | 10/27/2025 | OHS |
| K252467 | Disposable Vinyl Examination Gloves |
Viet Phu Trade And Import Export Co., Ltd. |
10/27/2025 | LYZ |
| K253106 | AngioVac Cannula | Angio Dynamics, Inc. | 10/24/2025 | DWF |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. |
10/24/2025 | NKB |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research Ab | 10/24/2025 | DQK |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | 10/24/2025 | MUH |
| K251784 | Hushd Pro Z-Link | Good Sleep Co Pte , Ltd. | 10/24/2025 | LRK |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components |
Howmedica Osteonics Corp., Dba Stryker Orthopaedics |
10/24/2025 | MBH |
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 10/24/2025 | IRP |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. |
10/24/2025 | IYE |
| K251974 | Arctic Sun Temperature Management System (Model 5000) |
Medivance, Inc. | 10/24/2025 | DWJ |
| K250345 | Medline Bag Decanter | Medline Industries, Lp. | 10/24/2025 | LHI |
| K253125 | Parietene™ Flat Sheet Mesh | Medtronic - Sofradim Production |
10/24/2025 | FTL |
| K253129 | Infinity™ OCT System | Medtronic Sofamor Danek Usa, Inc. |
10/24/2025 | NKG |
| K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek Usa, Inc. |
10/24/2025 | NKB |
| K252646 | Single-Use Fine Needle Biopsy (FNB) Device (NA-U210H) |
Olympus Medical Systems Corp. |
10/24/2025 | FCG |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. |
10/24/2025 | OWB |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub |
Philips Medical Systems Nederland B.V |
10/24/2025 | DQK |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 10/24/2025 | GJS |
| K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers Ag | 10/24/2025 | QIH |
| K251710 | Mobile X-ray Unit (!M1) | Solutions For Tomorrow Ab |
10/24/2025 | IZL |
| K253377 | Expandable Titanium PLIF/TLIF System |
Spectrum Spine, Inc. | 10/24/2025 | MAX |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | 10/24/2025 | QJP |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | 10/24/2025 | QEZ |
| K250904 | Atalante X | Wandercraft Sas | 10/24/2025 | PHL |
| K252357 | Glucose2 | Abbott Ireland | 10/24/2025 | CFR |
| K252931 | Invisalign® Palatal Expander System |
Align Technology, Inc. | 10/23/2025 | NXC |
| K253100 | MultiPulse TFL | Asclepion Laser Technologies Gmbh |
10/23/2025 | GEX |
| K250861 | Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid And Fentanyl In Simulated Gastric Acid (Black) |
Hartalega Ngc Sdn. Bhd | 10/23/2025 | LZA |
| K252345 | Picosecond Laser Device (PF131-BI) |
Risu Medical Technology Co., Ltd. |
10/23/2025 | GEX |
| K252425 | Silatrix Oral Gel | Sa3, LLC | 10/23/2025 | OLR |
| K250288 | TeraRecon Cardiovascular.Calcification.C T |
Terarecon,Inc. | 10/23/2025 | QIH |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical Sl | 10/23/2025 | NHA |
| K253226 | UV5000W Handle | Uroviu Corporation | 10/23/2025 | FAJ |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 10/23/2025 | DYB |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) |
Zhengzhou Pz Laser Slim Technology Co., Ltd. |
10/23/2025 | GEX |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test |
Acon Laboratories, Inc. | 10/22/2025 | SCA |
| K252569 | Carrier XL Delivery Catheter | Balt Usa, LLC | 10/22/2025 | QJP |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited |
10/22/2025 | OAP |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) |
Datex-Ohmeda., Inc. | 10/22/2025 | FMZ |
| K251628 | Mandibular Advancement Device L07 |
Dcstar, Inc. | 10/22/2025 | LRK |
| K252322 | SIros-X System | Genesys Spine | 10/22/2025 | OUR |
| K251289 | WELLlife COVID-19 Antigen Test Rx |
Guangzhou Wondfo Biotech Co., Ltd. |
10/22/2025 | QVF |
| K252298 | ANDI 2.0 | Imeka Solutions, Inc. | 10/22/2025 | QIH |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) |
Intervene | 10/22/2025 | QEW |
| K253144 | Freedom® Total Knee System – Titan PCK Components |
Maxx Orthopedics, Inc. | 10/22/2025 | JWH |
| K251977 | Electric Breast Pump (FZ-P8); Electric Breast Pump (YH-P8); Electric Breast Pump (YH-P8X) |
Ningbo Youhe Electrical Appliance Technology Co., Ltd. |
10/22/2025 | HGX |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute |
Prosidyan, Inc. | 10/22/2025 | MQV |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V QIAstat-Dx GI Panel 2 Mini B |
Qiagen Gmbh | 10/22/2025 | PCH |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 10/22/2025 | GAT |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 10/22/2025 | LLZ |
| K250955 | XC11 ICE System, USA | Yorlabs, Inc. | 10/22/2025 | OBJ |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | 10/22/2025 | LLL |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 10/21/2025 | MBI |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System |
Astura Medical | 10/21/2025 | NKB |
| K250394 | Fine TTO™ | Bodycad Laboratories, Inc. |
10/21/2025 | PBF |
| K251838 | Introducer Sheath Set | Cardiocycle Medical (Suzhou) Co.,Ltd |
10/21/2025 | DYB |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) |
Livsmed, Inc. | 10/21/2025 | GEI |
| K231897 | NeuroAlign Software | Medivis, Inc. | 10/21/2025 | HAW |
| K253249 | TriALTIS™ Spine System | Medos International Sarl | 10/21/2025 | NKB |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) |
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh |
10/21/2025 | KOI |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) |
Olympus Medical Systems Corporation |
10/21/2025 | FGE |
| K253033 | Chemfort® 28-day 20 Mm Vial Adaptor And 13 Mm Convertor |
Simplivia Healthcare , Ltd. |
10/21/2025 | ONB |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | 10/21/2025 | DQK |
| K242827 | A8 INTEGR8™ Porous Pedicle Screws |
Allumin8, Inc. | 10/20/2025 | NKB |
| K252665 | Brain™ Shoulder Positioning | Avatar Medical | 10/20/2025 | QIH |
| K252155 | AVAVA™ Skin Treatment System | Avava, Inc. | 10/20/2025 | ONG |
| K251414 | Miracu™ Polydioxanone (PDO) Suture And Needle (MONO) |
Feeltech Co., Ltd. | 10/20/2025 | NEW |
| K252640 | VereSee Optical Veres Needle And Endoscopic Camera |
Freyja Healthcare, LLC | 10/20/2025 | GCJ |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) |
Inkspace Imaging, Inc. | 10/20/2025 | MOS |
| K252319 | Q-Switched Nd: YAG Laser Machine (LFS-C13U) |
Sanhe Lefis Electronics Co., Ltd. |
10/20/2025 | GEX |
| K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) |
Vascular Flow Technologies Limited |
10/20/2025 | DSY |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. |
10/17/2025 | NHA |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 10/17/2025 | HSB |
| K250911 | MOSkin Radiation Measurement System |
Electrogenics Labs, Ltd. | 10/17/2025 | IYE |
| K250145 | Biopsy Port Adapter | Endosound, Inc. | 10/17/2025 | ODC |
| K251282 | StealthStation S8 Spine Software |
Medtronic Navigation, Inc. |
10/17/2025 | OLO |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) |
Olympus Medical Systems Corp. |
10/17/2025 | KNS |
| K251146 | IntelliVue Patient Monitors MX400, MX450, MX500, MX550 |
Philips Medizin Systeme Boeblingen Gmbh |
10/17/2025 | MHX |
| K252075 | Program Insite® Powder-Free, Disposable Nitrile Exam Gloves |
Program Insite, LLC | 10/17/2025 | LZA |
| K251778 | Remi Custom Night Guard | Remi | 10/17/2025 | OBR |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda |
10/17/2025 | NHA |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) |
Shenzhen Qianyu Technology Co., Ltd. |
10/17/2025 | NFO |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) |
Shenzhen Zhenxing Ruitong Technology Co., Ltd. |
10/17/2025 | OHS |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II |
Siemens Healthcare Diagnostics, Inc. |
10/17/2025 | JZO |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | 10/17/2025 | PLF |
| K251355 | X1-FFR | Spectrawave, Inc. | 10/17/2025 | QHA |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable |
Stryker Neurovascular | 10/17/2025 | HCG |
| K250203 | SureAx-Guide™ | Sureax Medical, LLC | 10/17/2025 | DQX |
| K250159 | Immunoglobulin Isotypes (GAM) For The EXENT Analyser; EXENT Analyser |
The Binding Site Group , Ltd. |
10/17/2025 | SGG |
| K251673 | X9 Ultrasound System | X9, Inc. | 10/17/2025 | SGH |
| K250852 | Coolfase | Asterasys Co., Ltd. | 10/16/2025 | GEI |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout |
Brainlab Ag | 10/16/2025 | LLZ |
| K252631 | Profoject™ Disposable Needle | Cmt Health Pte., Ltd. | 10/16/2025 | FMI |
| K253000 | CryoFreeze Wart And Skin Tag Remover |
Cryosurgery, Inc. | 10/16/2025 | GEH |
| K251497 | Elos Accurate Hybrid Base | Elosmedtech Pinol A/S | 10/16/2025 | NHA |
| K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) |
10/16/2025 | HHK |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) |
Matelaser, Inc. | 10/16/2025 | NVK |
| K242100 | SurgiAid Collagen Wound Dressing (HA) |
Maxigen Biotech, Inc. | 10/16/2025 | KGN |
| K252093 | Light Therapy Mask (1019055) | Merchsource, LLC | 10/16/2025 | OHS |
| K243727 | Re:Balans | Mode Sensors As | 10/16/2025 | DSB |
| K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | 10/16/2025 | QHH |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) |
Olympus Medical Systems Corporation |
10/16/2025 | FBK |
| K253114 | TargetCool™ (RM-DT02W) | Recensmedical, Inc. | 10/16/2025 | GEH |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 10/16/2025 | GAT |
| K252153 | FFX Facet Fixation System | Sc Medica | 10/16/2025 | MRW |
| K252223 | Alpha Endo Handpiece (Alpha Endo) |
Shenzhen Superline Technology Co., Ltd. |
10/16/2025 | EKX |
| K251994 | Arthrex Synergy Vision Imaging System |
Arthrex, Inc. | 10/16/2025 | GCJ |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing |
Penumbra, Inc. | 10/16/2025 | QEW |
| K252199 | AGFA HealthCare Enterprise Imaging |
Agfa Healthcare N.V. | 10/15/2025 | LLZ |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit |
Conmed Corporation | 10/15/2025 | MAI |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) |
Feeltech Co., Ltd. | 10/15/2025 | NEW |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System And The HBL Blade Assembly |
Hand Biomechanics Lab, Inc. |
10/15/2025 | |
| K252367 | InbellaMulti System | Inbella Medical, Inc. | 10/15/2025 | GEI |
| K252920 | ELEOS™ Limb Salvage System With NanoCept® Technology |
Onkos Surgical, Inc. | 10/15/2025 | QZZ |
| K253348 | TargetCool-e | Recensmedical, Inc. | 10/15/2025 | GEH |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 10/15/2025 | FMF |
| K251805 | Syngo.ct Dual Energy | Siemens Medical Solutions, Usa, Inc. |
10/15/2025 | JAK |
| K251294 | Bonafix Implant Abutments | Zentek Medical, LLC | 10/15/2025 | NHA |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 10/15/2025 | NHA |
