IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) |
Merit Medical Ireland, Ltd. |
01/31/2026 | DQX |
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) |
Asistan Medikal | 01/30/2026 | SCL |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | 01/30/2026 | GEX |
| K253318 | Clungene RSV Antigen Rapid Test |
Hangzhou Clongene Biotech Co., Ltd. |
01/30/2026 | GQG |
| K254305 | BAROguard Donor Lung Preservation System |
Paragonix Technologies, Inc. |
01/30/2026 | KDN |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx |
01/30/2026 | POK |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. |
01/30/2026 | EIH |
| K251407 | Motor Handpiece And Control Unit (SDI10) |
Saeshin Precision Co., Ltd. |
01/30/2026 | EBW |
| K252457 | Disposable Distal End Tape Hood |
Shanghai SeeGen Photoelectric Technology Co., Ltd. |
01/30/2026 | FDF |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) |
Shenzhen Jianchao Intelligent Technology Co., Ltd. |
01/30/2026 | OHS |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. |
01/30/2026 | DWF |
| K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | 01/29/2026 | MBI |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. |
01/29/2026 | INI |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. |
01/29/2026 | INI |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) |
Fresenius Medical Care Renal Therapies Group, LLC |
01/29/2026 | KPO |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) |
Hangzhou Hawk Optical Electronic Instruments Co., Ltd. |
01/29/2026 | GCJ |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 01/29/2026 | NHA |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits |
Hr Healthcare | 01/29/2026 | EZD |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
01/29/2026 | IOR |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 01/29/2026 | OUR |
| K252091 | Surgical Reality Viewer | Medicalvr B.V. | 01/29/2026 | QIH |
| K252684 | Labcorp Fentanyl Urine Visual Test |
Medtox Diagnostics, Inc. | 01/29/2026 | DJG |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | 01/29/2026 | QIH |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 01/29/2026 | NHA |
| K251354 | UV Smart D60 | Uv Smart Technologies B.V. |
01/29/2026 | SCS |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. |
01/29/2026 | INI |
| K252834 | Sacroiliac Joint Truss System (SJTS) |
4Web Medical | 01/28/2026 | OUR |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 01/28/2026 | MBI |
| K253254 | GBT Machine Airflow Prophylaxis Master |
E.M.S Electro Medical Systems S.A |
01/28/2026 | ELC |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. |
01/28/2026 | QKB |
| K253224 | MySOZO Software Version 6.0.1.2 (SW Version 6.0.1.2) |
ImpediMed Limited | 01/28/2026 | OBH |
| K252164 | NorthStar™ Mapping System | Imricor Medical Systems | 01/28/2026 | DQK |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing |
Koru Medical Systems, Inc. |
01/28/2026 | FRN |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology |
Medacta International S.A. |
01/28/2026 | LPH |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. |
01/28/2026 | IRP |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
01/28/2026 | OHS |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 01/28/2026 | DRT |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. |
01/28/2026 | FRG |
| K253842 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp |
01/28/2026 | |
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement |
Xelite Biomed , Ltd. | 01/28/2026 | NDN |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | 01/27/2026 | QAS |
| K254221 | Optima Coil System (OptiOne Coil System) |
Balt USA, LLC | 01/27/2026 | HCG |
| K251995 | Access Anti-hav IgM | Beckman Coulter, Inc. | 01/27/2026 | LOL |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 01/27/2026 | GEI |
| K254220 | Reusable 3 Button Fingerswitch Wand |
Soniquence, LLC | 01/27/2026 | GEI |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System |
Eyas Medical Imaging, Inc. |
01/26/2026 | LNH |
| K251670 | MAC 7 Resting ECG Analysis System |
Ge Medical Systems Information Technologies, Inc. |
01/26/2026 | DPS |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) |
Outset Medical, Inc. | 01/26/2026 | KDI |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
01/24/2026 | GEX |
| K252753 | Vydence Family Of Lasers | Vydence Medical Industria E Commercio Ltda |
01/24/2026 | GEX |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex |
Randox Laboratories Limited |
01/23/2026 | DJG |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 01/23/2026 | GCJ |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. |
01/23/2026 | LZA |
| K243349 | BodyGuardian Remote Monitoring System (BGRMS V3.0) |
Boston Scientific Cardiac Diagnostic Technologies, Inc. |
01/23/2026 | DSI |
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) |
Devicor Medical Products, Inc. |
01/23/2026 | NEU |
| K253285 | Elitone For Men | Elidah, Inc. | 01/23/2026 | QAJ |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) |
01/23/2026 | MOS |
| K253748 | Life Spine ProLift & ProLift Lateral And ProLift Lateral Fixated Expandable Spacer System |
Life Spine, Inc. | 01/23/2026 | MAX |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. |
01/23/2026 | QKB |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System |
Point Robotics MedTech, Inc. |
01/23/2026 | OLO |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) |
Shenzhen Kaiyan Medical Equipment Co., Ltd. |
01/23/2026 | OAP |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) |
Shenzhen Rainbow Technology Co., Ltd. |
01/23/2026 | OHS |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 01/23/2026 | FRO |
| K251511 | PhenoMATRIX | Copan Wasp Srl | 01/22/2026 | PPU |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System |
Astura Medical | 01/22/2026 | PML |
| K253652 | Genie MAX Large Bore Introducer Sheath |
Cultiv8 1, LLC | 01/22/2026 | DYB |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 01/22/2026 | KGN |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. |
01/22/2026 | NHA |
| K253315 | Straumann Variobase Abutments XC For Bridge/Bar |
Institut Straumann AG | 01/22/2026 | NHA |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System |
Lima Corporate S.P.A. | 01/22/2026 | PHX |
| K252307 | Getinge GSS67N Series Steam Sterilizer |
Maquet GmbH (A Getinge Group Company) |
01/22/2026 | FLE |
| K253498 | Pump In Style® Pro+ | Medela, LLC | 01/22/2026 | HGX |
| K252984 | Perin Health System (PHD80060-2) |
Perin Health Devices, LLC |
01/22/2026 | DRG |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. |
01/22/2026 | QIH |
| K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 01/22/2026 | QIH |
| K251281 | Nova Max Creat Egfr Monitoring System |
Nova Biomedical Corporation |
01/21/2026 | SHB |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System |
Arthrex, Inc. | 01/21/2026 | HRS |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | 01/21/2026 | GEX |
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) |
01/21/2026 | QFX |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. |
01/21/2026 | EBF |
| K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. |
01/21/2026 | NKG |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) |
Merit Medical Ireland, Ltd. |
01/21/2026 | DQX |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) |
Varian Medical Systems, Inc. |
01/21/2026 | IYE |
| K253730 | RoVo Mechanical Thrombectomy System |
Verge Medical, Inc. | 01/21/2026 | QEW |
| K251318 | VariFuse Adjustable Infusion Catheter |
Argon Medical Devices, Inc. |
01/20/2026 | QEY |
| K253291 | Excelsior System | Blue Ocean Global | 01/20/2026 | KTT |
| K253597 | Aplio Beyond And Aplio Me Software V2.0 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
01/20/2026 | IYN |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 Detector, Lux HD 43 Detector |
Carestream Health | 01/20/2026 | KPR |
| K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries With Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries With Drainage Holes |
Cooper Surgical | 01/20/2026 | HHW |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | 01/20/2026 | DWF |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) |
Scivita Medical Technology Co., Ltd. |
01/20/2026 | FBN |
| K253173 | Uct 780 With Uws-ct-dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
01/20/2026 | JAK |
| K252537 | Rusch SoftSimplastic Foley Catheters |
Teleflex Medical Sdn. Bhd. |
01/20/2026 | EZL |
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. |
01/18/2026 | DSA |
| K254085 | CARTO™ 3 EP Navigation System V9.0 With PIU Plus |
Biosense Webster, Inc. | 01/18/2026 | DQK |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. |
01/17/2026 | JXI |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter |
Medtronic, Ireland | 01/17/2026 | LOX |
| K251721 | Xpert GI Panel | Cepheid | 01/16/2026 | PCH |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis Hypogaea); Capture Reagent F076, Bos D 4 A-lactalbumin, Milk; Capture Reagent F077, Bos D 5 Ss-lactoglobulin, Milk; Capture Reagent F232, Gal D 2 Ovalbumin, Egg |
Hycor Biomedical | 01/16/2026 | DHB |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
01/16/2026 | DJG |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 01/16/2026 | GKZ |
| K252767 | Actitens Mini | Sublimed | 01/16/2026 | GZJ |
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 01/16/2026 | LCJ |
| K250135 | WAVE Clinical Platform (2.0.000) |
Baxter Healthcare Corp/ Excel Medical |
01/16/2026 | MWI |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System |
Curiteva, Inc. | 01/16/2026 | ODP |
| K251448 | FL-10000U Respiratory Humidifier |
Flexicare Medical Limited. |
01/16/2026 | BTT |
| K251739 | Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. | 01/16/2026 | NAY |
| K253556 | Da Vinci SP Surgical System (SP1098); Da Vinci E-200 Generator |
Intuitive Surgical, Inc. | 01/16/2026 | NAY |
| K251744 | Affinity Pixie™ Arterial Filter With Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter |
Medtronic | 01/16/2026 | DTM |
| K251900 | MY01 Continuous Compartmental Pressure Monitor |
MY01, Inc. | 01/16/2026 | LXC |
| K251367 | OptoMonitor 3 | Opsens, Inc. | 01/16/2026 | DXO |
| K251353 | Eyer 2 | Phelcom Technologies | 01/16/2026 | HKI |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. |
01/16/2026 | OWB |
| K251934 | Qxr-detect | Qure.Ai Technologies | 01/16/2026 | MYN |
| K252634 | Imagine® Enterprise Suite | Softlink International Private Limited |
01/16/2026 | QIH |
| K252960 | SOLIUS PRO UVB Light Panel | Solius Labs, Inc. | 01/16/2026 | RAB |
| K251790 | SeptAlign | Spirair, Inc. | 01/16/2026 | MHB |
| K251714 | Ion-C | SurGenTec, LLC | 01/16/2026 | MRW |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 01/16/2026 | QJP |
| K251341 | VITAL Tubing Sets For Hemodialysis |
Vital Healthcare Sdn. Bhd. |
01/16/2026 | FJK |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH |
01/16/2026 | NGX |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) |
Medtronic Minimed, Inc. | 01/15/2026 | QFG |
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 01/15/2026 | PSZ |
| K252934 | Diagnocat | DGNCT, LLC | 01/15/2026 | MYN |
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. |
01/15/2026 | PGM |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System |
Curiteva, Inc. | 01/15/2026 | ODP |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) |
Elekta Solutions AB | 01/15/2026 | IYE |
| K252567 | AltiVate Reverse® ADLC Glenosphere |
Encore Medical, L.P. | 01/15/2026 | PHX |
| K251458 | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. |
01/15/2026 | ITI |
| K251254 | Ignite RF System | Inmode , Ltd. | 01/15/2026 | GEI |
| K253925 | Aventus Thrombectomy System | Inquis Medical | 01/15/2026 | QEZ |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) |
Maxx Orthopedics, Inc. | 01/15/2026 | LZO |
| K251831 | Bio-Medicus Life Support Catheter And Introducer |
Medtronic, Inc. | 01/15/2026 | QHW |
| K251357 | Esperance Phlo Aspiration System |
Phenox, Ltd. | 01/15/2026 | NRY |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) |
Shanghai Bangbang Robotics Co., Ltd. |
01/15/2026 | ITI |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. |
01/15/2026 | PHX |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | 01/15/2026 | OUO |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask |
Sleepnet Corporation | 01/15/2026 | BZD |
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) |
Thera B Medical Products | 01/15/2026 | LBI |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) |
TriMed, Inc. | 01/15/2026 | HRS |
| K253585 | SmartGuard Technology; Predictive Low Glucose Technology |
Medtronic Minimed, Inc. | 01/14/2026 | QJI |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface |
Brainlab SE | 01/14/2026 | IYE |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff |
Cardinalhealth | 01/14/2026 | LZC |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | 01/14/2026 | GEI |
| K251419 | Laboratorios Biogalenic Sterile Water For Inhalation, USP |
Laboratorios Biogalenic S.A. DE C.V. |
01/14/2026 | BTT |
| K253511 | Concerto Versa™ Detachable Coil |
Medtronic, Inc. | 01/14/2026 | KRD |
| K252958 | METICULY Patient-specific Titanium Mesh Implant |
Meticuly Co., Ltd. | 01/14/2026 | GXN |
| K254190 | Ds Base 1.5T; Ds Base 3.0T; Ds Head 1.5T; Ds Head 3.0T; Ds HeadNeck 1.5T; Ds HeadNeck 3.0T |
Philips Medical Systems Nederland B.V. |
01/14/2026 | MOS |
| K252219 | Cervical Interbody And VBR Fusion System |
Sync Surgical | 01/14/2026 | ODP |
| K252579 | Orthoscan TAU MVP Mini C-Arm System |
Ziehm-Orthoscan, Inc. | 01/14/2026 | OXO |
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | 01/13/2026 | EJK |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, And Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, And Simulated Gastric Acid |
Kossan International Sdn Bhd |
01/13/2026 | LZA |
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
Miach Orthopaedics, Inc. | 01/13/2026 | QNI |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) |
Spectrum Dynamics Medical, Ltd. |
01/13/2026 | KPS |
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod |
Spinal Resources, Inc. | 01/13/2026 | NKB |
| K254014 | Connected OR Hub With Device And Voice Control; SDC4K Information Management System With Device And Voice Control |
Stryker Endoscopy | 01/13/2026 | GCJ |
| K252807 | Arthrex Anatomic Lapidus Plates And I-Beam Lapidus Plates |
Arthrex, Inc. | 01/12/2026 | HRS |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) |
Beatles Medical Supplies (Xiantao) Co., Ltd. |
01/12/2026 | FXX |
| K251988 | Boston Iface (Boston Iface) | Boston Aesthetics, Inc. | 01/12/2026 | GEI |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division |
01/12/2026 | EBW |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 01/12/2026 | IOR |
| K251388 | Dental Air-motor Handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) |
Foshan Topmed Dental Co., Ltd. |
01/12/2026 | EFB |
| K251389 | High Speed Air Turbine Handpiece |
Foshan Topmed Dental Co., Ltd. |
01/12/2026 | EFB |
| K253167 | Any-Paste | Mediclus Co., Ltd. | 01/12/2026 | KIF |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) |
Precision AI Pty, Ltd. | 01/12/2026 | QHE |
| K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC |
01/12/2026 | OLO |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) |
Shenzhen Hingmed Medical Instrument Co., Ltd. |
01/12/2026 | DXN |
| K250890 | SBC1 Cream | Sioxmed, LLC | 01/12/2026 | FRO |
| K252913 | Break Wave | Sonomotion, Inc. | 01/12/2026 | LNS |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. |
01/12/2026 | GEH |
| K252842 | SafeOp 3: Neural Informatix System |
Alphatec Spine, Inc. | 01/11/2026 | GWF |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. |
01/09/2026 | GFO |
| K252847 | NextAR Hip Platform | Medacta International S.A. |
01/09/2026 | SBF |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
01/09/2026 | CGX |
| K251157 | Core Metabolic | Truvian Health | 01/09/2026 | CIX |
| K252589 | Corvair Monza | AliveCor, Inc. | 01/09/2026 | MHX |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) |
Ethicon Endo-Surgery, LLC |
01/09/2026 | OXC |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 01/09/2026 | PHX |
| K251139 | KabiHelp® Uno; KabiHelp® Advance Plus |
Fresenius Kabi AG | 01/09/2026 | KPE |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) |
Gi Windows, Inc. | 01/09/2026 | SAH |
| K252339 | Iotasoft® Insertion System | Iotamotion, Inc. | 01/09/2026 | QQH |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, And SP Series |
Liaoning Upcera Co., Ltd. |
01/09/2026 | EIH |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8 D,RN3D,MJ4D,RN1D,RN2D) |
Ningbo Ranor Medical Technology Co., Ltd. |
01/09/2026 | DXN |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) |
Solo Pace, Inc. | 01/09/2026 | DQX |
| K253075 | Mobility Scooter (Air Classic); Mobility Scooter (Air Traveller); Mobility Scooter (Air Traveller2.0) |
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
01/09/2026 | INI |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) |
Unimed Medical Supplies, Inc. |
01/09/2026 | DXQ |
| K253512 | MiniMed Go App | Medtronic Minimed | 01/08/2026 | NDC |
| K253639 | View | Ge Healthcare | 01/08/2026 | LLZ |
| K253370 | LOGIQ Totus | Ge Medical Systems Ultrasound and Primary Care Diagnostics |
01/08/2026 | IYN |
| K252794 | Vision-MR™ Diagnostic Catheter |
Imricor Medical Systems, Inc. |
01/08/2026 | DRF |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device |
Intelivation Technologies |
01/08/2026 | ODP |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 01/08/2026 | DZE |
| K252759 | Revyve® Antimicrobial Skin And Wound Cleanser |
Kane Biotech, Inc. | 01/08/2026 | FRO |
| K251160 | Sterile Temperature Probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) |
Shenzhen Med-Link Electronics Tech Co., Ltd. |
01/08/2026 | FLL |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. |
01/08/2026 | LLZ |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 01/08/2026 | MAX |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) |
Tornier, Inc. | 01/08/2026 | PHX |
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory |
01/08/2026 | KNG |
| K253923 | PuraStat | 3-D Matrix Europe SAS | 01/07/2026 | PHN |
| K253924 | PuraStat | 3-D Matrix Europe SAS | 01/07/2026 | QAU |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body |
Aidoc Medical , Ltd. | 01/07/2026 | QAS |
| K252507 | SmileInspector | Amv Consulting, LLC | 01/07/2026 | PNN |
| K251207 | Sangria™ Thrombectomy System | Avantec Vascular Corporation |
01/07/2026 | QEW |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited |
01/07/2026 | NXC |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 01/07/2026 | MYN |
| K253366 | LOGIQ Fortis | Ge Medical Systems Ultrasound and Primary Care Diagnostics |
01/07/2026 | IYN |
| K250305 | Reprocessed Agilis NxT Steerable Introducer |
Innovative Health | 01/07/2026 | PNE |
| K252727 | Neodent InLab Validated Workflow |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
01/07/2026 | NHA |
| K252890 | ZenSeal Pro | Kerr Corporation | 01/07/2026 | KIF |
| K253308 | Materialise Personalized Guides And Models For Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models |
Materialise N.V | 01/07/2026 | PPT |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) |
Medtronic Sofamor Danek USA, Inc. |
01/07/2026 | NKB |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 01/07/2026 | BZD |
| K253990 | KHEIRON® Spinal Fixation System, Including Patient Specific K-ROD |
S.M.A.I.O | 01/07/2026 | NKB |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) |
Shenzhen Best Electronics Co., Ltd. |
01/07/2026 | DQA |
| K253158 | VyBrate™ VBR System | Vy Spine, LLC | 01/07/2026 | MQP |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 01/06/2026 | MBI |
| K252894 | Aprevo® Cervical Interbody System |
Carlsmed, Inc. | 01/06/2026 | ODP |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems |
01/06/2026 | HRS |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 01/06/2026 | PAY |
| K252886 | Pen Needle | Hh Global Technology, Inc. |
01/06/2026 | FMI |
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited |
01/06/2026 | SGR |
| K253793 | Materialise TKA Guide System | Materialise N.V | 01/06/2026 | JWH |
| K252749 | Medconn 8K Glycated Hemoglobin Test System |
Shanghai Medconn Medical Technology Co., Ltd. |
01/06/2026 | PDJ |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 01/06/2026 | QJP |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution |
Innovacyn, Inc. | 01/05/2026 | FRO |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. |
01/05/2026 | QJP |
| K253008 | Mailink | Maihub Corp. | 01/05/2026 | LLZ |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 01/05/2026 | FXX |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 01/05/2026 | IYE |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
01/05/2026 | IYN |
| K251630 | Atellica IM Total PSA II (tPSAII) |
Siemens Healthcare Diagnostics, Inc. |
01/05/2026 | LTJ |
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit |
ZuriMED Technologies AG | 01/02/2026 | OWX |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | 01/02/2026 | GXP |
| K251178 | Ready To Use Nelaton Catheter | Jamjoom Fullcare Corporation |
01/02/2026 | EZD |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. |
01/02/2026 | INI |
| K252951 | Genesis Sleep | Neurofield, Inc. | 12/31/2025 | QJQ |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 12/31/2025 | HWC |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) |
Arc Trauma, LLC | 12/31/2025 | DXC |
| K253305 | TENS AND EMS (TENS And Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) |
Shenzhen Jiantuo Electronics Co., Ltd. |
12/31/2025 | NUH |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 12/31/2025 | NEU |
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) |
Techno-Path Manufacturing , Ltd. |
12/30/2025 | QCH |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 X 10 Mm |
Arthrex, Inc. | 12/30/2025 | MBI |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer |
Lucas Lifecare | 12/30/2025 | FLE |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. |
12/30/2025 | KPS |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. |
12/30/2025 | QIH |
| K251091 | Lipids | Truvian Health | 12/30/2025 | CHH |
| K253343 | Celebrace Software | Celebrace | 12/29/2025 | PNN |
| K251025 | Mon-a-Therm™ Esophageal Stethoscope With Temperature Sensor 400TM (90041, 90042, 90043, 90049) |
Covidien, LLC | 12/29/2025 | BZT |
| K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT With TaperGuard™ Cuff, Distal With Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT With TaperGuard™ Cuff, Proximal With Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal With Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal With Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT |
Covidien, LLC | 12/29/2025 | JOH |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. |
12/29/2025 | CAW |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) |
Shenzhen Fansizhe Science And Technology Co., Ltd. |
12/29/2025 | OHT |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent |
Taewoong Medical Co., Ltd. |
12/29/2025 | FGE |
| K253325 | ZipToe™ Hammertoe Fusion System |
Toetal Solutions | 12/29/2025 | HTY |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 12/24/2025 | OHS |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) |
Light Tree Ventures Europe B.V. |
12/24/2025 | OAP |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) |
Shenzhen Saidi Light Therapy Technology Co., Ltd. |
12/24/2025 | OHS |
| K253342 | PICO-K | Speclipse, Inc. | 12/24/2025 | GEX |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, And Nano L12 EXP) |
Edan Instruments, Inc. | 12/23/2025 | IYN |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 12/23/2025 | NFO |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens With UV Blocking For Presbyopia (EDOF) |
Bruno Vision Care, LLC | 12/23/2025 | LPL |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 12/23/2025 | OBO |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 |
Diasorin Molecular, LLC | 12/23/2025 | QOF |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,H LG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) |
Dongguan Yijiaming Technology Co., Ltd. |
12/23/2025 | OHS |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 12/23/2025 | |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 12/23/2025 | LNH |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) |
Guangdong Prestige Technology Co., Ltd. |
12/23/2025 | INI |
| K251800 | Healgen® URS Test Strips | Healgen Scientific, LLC | 12/23/2025 | JMT |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
Healgen Scientific, LLC | 12/23/2025 | NGL |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) |
Hong Qiangxing (Shenzhen) Electronics Limited |
12/23/2025 | NUH |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp Spp.); Capture Reagent F207, Clam (Mercenaria Mercenaria); Capture Reagent F256, Walnut (Juglans Spp.) ; Capture Reagent I006, German Cockroach (Blatella Germanica) |
Hycor Biomedical | 12/23/2025 | DHB |
| K253072 | Paruu Wearable Breast Pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) |
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. |
12/23/2025 | HGX |
| K253341 | Custom Abutments AS | Medentika GmbH | 12/23/2025 | NHA |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) |
Medimaging Integrated Solution, Inc (Miis) |
12/23/2025 | HRX |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 12/23/2025 | DZI |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 12/23/2025 | NHA |
| K253675 | OsteoRemedies Hip Spacer System |
Osteoremedies, LLC | 12/23/2025 | KWL |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC |
12/23/2025 | DZE |
| K252145 | GEN5™ And GEN5+™ 3.3mmD Dental Implants |
Paragon Implant Mfg., LLC |
12/23/2025 | DZE |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. |
12/23/2025 | OHT |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) |
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. |
12/23/2025 | JOJ |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) |
Shenzhen Siken 3D Technology Development Co., Ltd. |
12/23/2025 | NFO |
| K253239 | Active-V Total Knee System; World Total Knee System |
Signature Orthopaedics Pty, Ltd. |
12/23/2025 | MBH |
| K253122 | Sim&Size | Sim&Cure | 12/23/2025 | PZO |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 12/23/2025 | MUJ |
| K253281 | UpDoc | Updoc, Inc. | 12/23/2025 | NDC |
| K252361 | AccurECG Analysis System (v2.0) |
Accurkardia, Inc. | 12/22/2025 | DPS |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 12/22/2025 | HTN |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G And BT-PDS-SERIES-G |
Bioteque Corporation | 12/22/2025 | FGE |
| K250959 | BioticsAI | Bioticsai, Inc. | 12/22/2025 | IYN |
| K252611 | Aprevo® Cervical Plating System |
Carlsmed, Inc. | 12/22/2025 | KWQ |
| K251605 | DIMPLO Implant System | Dimplo , Ltd. | 12/22/2025 | DZE |
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation |
12/22/2025 | PKP |
| K252981 | EmbraceMini | Empatica S.R.L. | 12/22/2025 | LEL |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device |
Ethicon, Inc. | 12/22/2025 | GAM |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) |
Globus Medical, Inc. | 12/22/2025 | OVE |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 12/22/2025 | FMF |
| K253664 | SKOUT System | Iterative Health | 12/22/2025 | QNP |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 12/22/2025 | FXX |
| K252673 | LacertaMatrix | Lacerta Life Science | 12/22/2025 | KGN |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 12/22/2025 | OWB |
| K252856 | PeekMed Web | Peek Health, S.A. | 12/22/2025 | QIH |
| K252557 | Lumify Diagnostic Ultrasound System |
Philips Ultrasound, LLC | 12/22/2025 | IYN |
| K250756 | Pression Wave PRO External Counter-Pulsation System |
Pression, Inc. | 12/22/2025 | DRN |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. |
12/22/2025 | CAW |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) |
12/22/2025 | MUJ |
| K252616 | Portable Oxygen Concentrator (JLO-190P) |
Shenzhen Homed Medical Device Co., Ltd. |
12/22/2025 | CAW |
| K251783 | Inspire HCR And HCR DUAL Cardiotomy Reservoirs |
Sorin Group Italia S.R.L. |
12/22/2025 | DTN |
| K253339 | Theracor | Stimlabs, LLC | 12/22/2025 | KGN |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation |
12/22/2025 | FZP |
| K253903 | InnoClip Disposable Clip Applier |
Taiwan Surgical Corporation |
12/22/2025 | FZP |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 12/22/2025 | OLO |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) |
Zhejiang Gongdong Medical Technology Co., Ltd. |
12/22/2025 | MMK |
| K251159 | Power Wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. |
12/22/2025 | ITI |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 12/19/2025 | NEZ |
| K251469 | Endura™ Ureteral Stent And Stent Set |
Cathegenix (Xiamen) Co., Ltd. |
12/19/2025 | FAD |
| K252284 | Emurmur Heart AI | Csd Labs | 12/19/2025 | DQD |
| K251152 | DBLG2 | Diabeloop | 12/19/2025 | QJI |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay |
Diazyme Laboratories, Inc. |
12/19/2025 | DFH |
| K252974 | EMPOWR Knee | Encore Medical, L.P. | 12/19/2025 | JWH |
| K253479 | Optiflow Switch+ Filtered Nasal Interface With CO2 Sampling (AA042J) |
Fisher &Paykel Healthcare , Ltd. |
12/19/2025 | BTT |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio |
12/19/2025 | HRS |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) |
Guangdong Youmeng Electrical Technology Co., Ltd. |
12/19/2025 | HGX |
| K252754 | Wearable Electric Breast Pump (YM-8803) |
Guangdong Youmeng Electrical Technology Co., Ltd. |
12/19/2025 | HGX |
| K252029 | AI-CVD | HeartLung Corporation | 12/19/2025 | QIH |
| K254063 | Icem Universal Plus | Kulzer, LLC | 12/19/2025 | EMA |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 12/19/2025 | KTI |
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 12/19/2025 | NQQ |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) |
Medicrea International S.A.S. (Medtronic) |
12/19/2025 | MAX |
| K250864 | MatriDerm Plus+ Bi-Layer | Medskin Solutions Dr. Suwelack AG |
12/19/2025 | KGN |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) |
Medtronic, Inc. | 12/19/2025 | DQY |
| K252892 | SCOUT MD Surgical Guidance System |
Merit Medical Systems, Inc. |
12/19/2025 | NEU |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. |
12/19/2025 | ODP |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
12/19/2025 | DXN |
| K251037 | Rectal Applicator | Nucletron B.V. | 12/19/2025 | JAQ |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. |
12/19/2025 | CBK |
| K253161 | Balanced Knee System TriMax Porous Femoral Components |
Ortho Development Corp. | 12/19/2025 | MBH |
| K253613 | Monkey Rings External Ring Fixation System |
Paragon 28, Inc. | 12/19/2025 | KTT |
| K251572 | Erapid With Etrack System | Pari Respiratory Equipment, Inc. |
12/19/2025 | CAF |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 12/19/2025 | IZL |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
12/19/2025 | FRO |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 12/19/2025 | MUJ |
| K253733 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 12/19/2025 | DQK |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) |
Sanhe Lefis Electronics Co., Ltd. |
12/19/2025 | GEX |
| K251077 | JOULE 1064nm System And Accessories |
Sciton, Inc. | 12/19/2025 | GEX |
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. |
12/19/2025 | PGY |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) |
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. |
12/19/2025 | OHS |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. |
12/19/2025 | DQA |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise |
Siemens Healthcare GmbH | 12/19/2025 | LNH |
| K253616 | ProtekDilate Vascular Access Kit |
Sorin Group Italia S.R.L. |
12/19/2025 | DRE |
| K253373 | Southern Craniomaxillofacial (CMF) System |
Southern Medical (Pty) , Ltd. |
12/19/2025 | JEY |
| K253202 | Hoffmann LRF System | Stryker GmbH | 12/19/2025 | KTT |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) |
Sunglor Technology Co., Ltd. |
12/19/2025 | OHS |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer |
Surgical Instrument Service and Savings, Inc. |
12/19/2025 | PNE |
| K252670 | Alzevita | TOPIA MEDTECH LIMITED | 12/19/2025 | QIH |
| K251074 | Tru Liver Health Test Panel | Truvian Health | 12/19/2025 | CJE |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | 12/19/2025 | NUC |
| K252877 | SANDRO Dual | Wontech Co., Ltd. | 12/19/2025 | GEX |
| K253516 | Assert-IQ (DM5100) | Abbott Medical | 12/18/2025 | MXD |
| K250914 | MediAI-BA | Crescom Co., Ltd. | 12/18/2025 | QIH |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) |
Edwards Lifesciences | 12/18/2025 | DQK |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. |
12/18/2025 | QEW |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | 12/18/2025 | GEI |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC |
12/18/2025 | KDI |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) |
Jiangsu Jiyuan Medical Technology Co., Ltd. |
12/18/2025 | HIH |
| K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) |
12/18/2025 | OLR |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter |
Natec Medical , Ltd. | 12/18/2025 | LIT |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) |
Olympus Medical Systems Corporation |
12/18/2025 | FDX |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) |
Ovesco Endoscopy AG | 12/18/2025 | PKL |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. |
12/18/2025 | LRK |
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 |
Reflexion Medical, Inc. | 12/18/2025 | QVA |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 12/18/2025 | NHA |
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. |
12/18/2025 | PND |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) |
Tomey Corporation | 12/18/2025 | MXK |
| K252235 | PVAD IQ Software | Ultrasight , Ltd. | 12/18/2025 | QIH |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) |
Abbott Medical | 12/17/2025 | DQY |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System |
Bonebridge AG | 12/17/2025 | HRS |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. | 12/17/2025 | QBJ |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate |
12/17/2025 | FMF |
| K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) |
Ethicon Endo-Surgery, LLC |
12/17/2025 | GDW |
| K253093 | Vital™ Spinal Fixation System |
Highridge Medical, LLC | 12/17/2025 | NKB |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 12/17/2025 | DYB |
| K252922 | Neosoma Brain Mets | Neosoma, Inc. | 12/17/2025 | QIH |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 12/17/2025 | QVP |
| K253721 | KHEIRON® Spinal Fixation System, Including Patient Specific K-ROD |
S.M.A.I.O | 12/17/2025 | NKB |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) |
Shenzhen Comen Medical Instruments Co.,Ltd |
12/17/2025 | MHX |
| K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) |
Shenzhen Goodwind Technology Development Co., Ltd. |
12/17/2025 | OHS |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter |
Terumo Medical Products (Hangzhou) Co., Ltd. |
12/17/2025 | FOZ |
| K251416 | UltraSight Guidance | Ultrasight , Ltd. | 12/17/2025 | QJU |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons |
Unibeauty (Hubei) Technology Co., Ltd. |
12/17/2025 | HEB |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) |
Pentax of America, Inc. | 12/16/2025 | FDS |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) |
Baxter Healthcare Corporation |
12/16/2025 | DXQ |
| K252111 | Versius Surgical System (Versius Plus) |
Cmr Surgical Limited | 12/16/2025 | SCV |
| K253118 | Companion Spine DIAM™ Instrumentation |
Companion Spine France | 12/16/2025 | QLR |
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 |
Fujirebio Diagnostics,Inc. |
12/16/2025 | OVK |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 12/16/2025 | GAM |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) |
Guangzhou Red Pine Medical Instrument Co., Ltd. |
12/16/2025 | FGB |
| K251763 | IRISeg | Intuitive Surgical, Inc. | 12/16/2025 | QIH |
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) |
PolyConversions, Inc. | 12/16/2025 | QPC |
| K252204 | Prolaio Evo2peak Module (Version 1.0) |
Prolaio, Inc. | 12/16/2025 | PPW |
| K252268 | V Series Portable Oxygen Concentrator (V5, V5C, V6, V6C) |
Shenzhen Harveymed Technology Co., Ltd. |
12/16/2025 | CAW |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. |
12/16/2025 | HSX |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited |
12/16/2025 | OWB |
| K252373 | BioFlo Hybrid PICC With ENDEXO Technology And PASV Valve Technology; BioFlo PICC With ENDEXO Technology And PASV Valve Technology; BioFlo PICC With ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC With PASV Valve Technology; Xcela Hybrid PICC With PASV Valve Technology |
Spectrum Vascular | 12/16/2025 | LJS |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. |
12/16/2025 | IYE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope Camera System (GY-AIO-121) |
Zhejiang Geyi Medical Instrument Co., Ltd. |
12/16/2025 | FGB |
| K253741 | V•Stick™ Vascular Access Set |
Argon Medical Devices, Inc. |
12/15/2025 | DYB |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 12/15/2025 | OLI |
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) |
Femasys, Inc. | 12/15/2025 | LKF |
| K252935 | Hybrid Personal Lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) |
Foshan Pingchuang Medical Technology Co., Ltd. |
12/15/2025 | NUC |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper |
Howmedica Osteonics Corp., Dba Stryker Orthopaedics |
12/15/2025 | KRO |
| K253677 | Tembo Embolic System | Instylla, Inc. | 12/15/2025 | KRD |
| K252675 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 12/15/2025 | NAY |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | 12/15/2025 | QSY |
| K252950 | Paradigm System | Proprio, Inc. | 12/15/2025 | OLO |
| K251770 | SleepRes PAP System | Sleepres, Inc. | 12/15/2025 | BZD |
| K253101 | HyperVue™ Imaging System - Integrated |
Spectrawave, Inc. | 12/15/2025 | NQQ |
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System |
Spineology, Inc. | 12/15/2025 | OQB |
| 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 | FMF |
| 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 |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 12/11/2025 | HRS |
| 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 |
| 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 |
| K251199 | Allia Moveo | GE Medical Systems SCS | 12/09/2025 | OWB |
| 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 |
| 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 |
| K250258 | HeartBeam AIMIGo With 12-L ECG Synthesis Software System |
Heartbeam, Inc. | 12/08/2025 | DXH |
| 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 |
| 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 |
| 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 |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 Μg) GEP10 |
Thermo Fisher Scientific (Oxoid Ltd.) |
12/05/2025 | JTN |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH |
12/05/2025 | HRX |
| 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 |
| 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 |
| K251943 | Spineology Navigation Instruments |
Spineology, Inc. | 12/04/2025 | OLO |
