De Novo

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De Novo Number	Device Name	Applicant	Decision Date	Procode
DEN240062	Minder System	epi-minder pty ltd	04/17/2025	SEM
DEN240064	CT-132	click therapeutics, inc.	04/11/2025	SEE
DEN240021	Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))	active protective technologies, inc.	04/09/2025	SEC
DEN240031	Prapela SVS Hospital Bassinet Pad (model P01)	prapela, inc.	04/04/2025	QVY
DEN240020	Visby Medical Women's Sexual Health Test	visby medical, inc.	03/28/2025	SEA
DEN240018	CORIS System	nanosonics limited	03/19/2025	FEB
DEN230051	Myocene	myocene	01/17/2025	SDX
DEN240014	ARC-EX System	onward medical inc.	12/19/2024	SDO
DEN240025	VENTANA Kappa And Lambda Dual ISH Mrna Probe Cocktail (08507023001)	ventana medical systems, inc.	12/05/2024	SDP
DEN240023	SmartFlow Neuro Cannula	clearpoint neuro, inc.	11/13/2024	SDG
DEN230085	VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator	steris	11/12/2024	SDC
DEN230083	Valeda Light Delivery System	lumithera, inc.	11/04/2024	SDE
DEN230082	Stone Clear (SC-LP9-01)	sonomotion, inc.	10/30/2024	QNA
DEN230084	Dexter L6 System	distalmotion, sa	10/25/2024	SDD
DEN230087	AMStent® Tracheobronchial Covered Stent System	peytant solutions, inc.	10/16/2024	SDB
DEN230078	Versius Surgical System	cmr surgical limited	10/11/2024	SCV
DEN230076	Omron Blood Pressure Monitor With Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor With Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))	omron healthcare, inc.	10/08/2024	QXY
DEN240029	Healgen Rapid Check COVID-19/Flu A&B Antigen Test	healgen	10/07/2024	SCA
DEN230011	OcuCool	recensmedical, inc.	09/30/2024	QZQ
DEN240017	ShortCut	pi-cardia ltd.	09/27/2024	SCZ
DEN230081	Hearing Aid Feature (HAF)	apple inc.	09/12/2024	SCR
DEN230067	Chronos®	germitec	08/28/2024	SCS
DEN230090	First To Know Syphilis Test	nowdiagnostics	08/16/2024	SBZ
DEN210037	SoClean 3+ Bacterial Reduction Device	soclean, inc.	08/12/2024	QXQ
DEN230046	PGDx Elio Plasma Focus Dx	personal genome diagnostics, inc.	08/01/2024	SBY
DEN230061	Allay Nerve Cap	tulavi therapeutics	07/16/2024	SBG
DEN230092	Simplexa C. Auris Direct, Simplexa C. Auris Positive Control Pack, Simplexa C. Auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)	diasorin molecular llc	07/15/2024	SBT
DEN220042	Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)	terragene sa	07/12/2024	QVB
DEN240013	MagDI System	gt metabolic solutions, inc.	07/02/2024	SAH
DEN240007	BioHealx Anal Fistula Device	signum surgical limited	07/01/2024	QML
DEN240016	Xpert HCV; GeneXpert Xpress System	cepheid	06/27/2024	SBP
DEN230055	FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System	balance ophthalmics, inc.	06/27/2024	QQJ
DEN230069	Mi-CHORD System	lsi solutions, inc.	06/11/2024	SBK
DEN230068	3M™ Attest™ Ebowie-dick Test Card 10135 3M™ Attest™ Ebowie-dick Card Holder 10135CH 3M™ Attest™ Ebowie-dick Auto-reader 1190	3m company	05/21/2024	JOJ
DEN230035	DentalMonitoring	dental monitoring sas	05/17/2024	SBC
DEN230043	Notal Vision Home Optical Coherence Tomography (OCT) System	notal vision inc	05/15/2024	SAX
DEN230052	Eversense AP CGM System	senseonics, incorporated	04/29/2024	SBA
DEN230023	Rho	16 bit inc	04/09/2024	SAO
DEN230032	Symani Surgical System	mmi north america, inc.	04/05/2024	SAQ
DEN220015	Orthobond Mariner Pedicle Screw System	orthobond coporation	04/05/2024	QZY
DEN210058	ELEOSx™ Limb Salvage System	onkos surgical	04/05/2024	QZZ
DEN230036	Sepsis ImmunoScore	prenosis, inc.	04/02/2024	SAK
DEN210049	Medline ART Skin Harvesting System	medline industries, inc	03/27/2024	QYK
DEN230034	X100 With Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT With Full Field Bone Marrow Aspirate (BMA) Application	scopio labs ltd.	03/22/2024	SAL
DEN230024	Technozym ADAMTS13 Activity	technoclone herstellung von diagnostika und arzneimitteln gm	02/28/2024	SAC
DEN230025	MIRA Surgical System	virtual incision	02/23/2024	SAB
DEN230064	BraidE Embolization Assist Device	rapid medical ltd.	02/21/2024	QZU
DEN210035	“Genius™ Digital Diagnostics System With The Genius™ Cervical AI Algorithm”	hologic inc.	01/31/2024	QYV
DEN220009	VerTouch Spinal Imaging Device	intuitap medical, inc.	01/19/2024	QXD
DEN230015	Osteoboost Belt	bone health technologies, inc	01/12/2024	QZO
DEN230008	DermaSensor	dermasensor inc.	01/12/2024	QZS
DEN220040	Fibresolve	imvaria, inc	01/12/2024	QWO
DEN220066	BrainSee	darmiyan, inc.	01/11/2024	QWT
DEN230020	BioTraceIO Lite	techsomed medical technologies ltd.	12/22/2023	QZL
DEN230050	Body Temperature Software (BTS)	fitbit llc	12/15/2023	QZA
DEN230027	NaviCam ProScan	ankon technologies co., ltd	12/12/2023	QZF
DEN230045	Sonu	sound health systems, inc.	12/04/2023	QZC
DEN200070	Simple 2 Test	letsgetchecked inc. (formerly privapath diagnostics inc.)	11/15/2023	QYA
DEN220091	Dream Sock	owlet baby care, inc.	11/08/2023	QYU
DEN220090	EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)	stemcell technologies canada inc.	11/06/2023	QYO
DEN200076	ORi	masimo corporation	10/12/2023	QWE
DEN220087	Edison System	histosonics, inc.	10/06/2023	QGM
DEN230002	DuraGraft	marizyme, inc.	10/04/2023	QEJ
DEN220023	Procise ADL	procisedx inc.	09/29/2023	QYD
DEN210056	Procise IFX	procisedx inc.	09/29/2023	QXT
DEN210011	Invitae Common Hereditary Cancers Panel	invitae corporation	09/29/2023	QVU
DEN220026	VasQ	laminate medical technologies ltd.	09/26/2023	QVQ
BR220665	Hemanext ONE	Hemanext, Inc.	09/15/2023	QYC
DEN230021	Ensoetm	advanced cooling therapy, inc. d/b/a attune medical	09/13/2023	QXV
DEN230006	Esolution	s4 medical corp	09/06/2023	QXU
DEN230007	LightStrike+ (MXSUV1-SL And MXSUV1-FT)	xenex disinfection services, inc.	09/01/2023	QXJ
DEN220052	BrachyGel Vaginal Hydrogel Packing System	brachyfoam, inc. d/b/a advaray	08/22/2023	QXR
DEN230019	AXIOS Stent And Electrocautery-Enhanced Delivery System (10mm X 10mm Stent); AXIOS Stent And Electrocautery-Enhanced Delivery System (15mm X 10mm Stent)	boston scientific corporation	08/18/2023	QXH
DEN220073	Revi System	bluewind medical ltd.	08/16/2023	QXM
DEN230003	Viz HCM	viz.ai, inc.	08/03/2023	QXO
DEN220047	Galen ES Cooperative Surgical Assistant Platform, Galen ES	galen robotics	07/19/2023	QXG
DEN230012	Ruthless Spine RJB	ruthless, llc dba ruthless spine	07/14/2023	QWL
DEN220058	BT-001	better therapeutics	07/07/2023	QXC
DEN200052	KidneyIntelX.dkd	renalytix ai, inc.	06/29/2023	QWZ
DEN220048	Neoasis	invictus medical, inc.	06/16/2023	QWX
DEN220078	Eroxon	futura medical developments limited	06/09/2023	QWW
DEN220028	Cue COVID-19 Molecular Test	cue health inc.	06/06/2023	QWB
DEN220041	Tristel Duo ULT	tristel solutions limited	06/02/2023	QWS
DEN220027	B·R·A·H·M·S Sflt-1/ PlGF KRYPTOR Test System	brahms gmbh, part of thermo fisher scientific	05/18/2023	QWH
DEN220083	Stanza	swing therapeutics, inc.	05/09/2023	QWI
DEN210040	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators	ortho-clinical diagnostics, inc.	05/05/2023	QVP
DEN210038	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator	ortho-clinical diagnostics, inc.	05/05/2023	QVP
DEN220082	Breast Implant Removal Device (BIRD)	gaylord solutions, llc	04/20/2023	QVS
DEN220059	NTX100 Tonic Motor Activation (NTX100 ToMAc) System	noctrix health, inc.	04/17/2023	QWD
DEN220033	MISHA Knee System	moximed, inc.	04/10/2023	QVV
DEN210055	The N-SWEAT Patch	candesant biomedical, inc.	04/07/2023	QVX
DEN200011	Masimo SafetyNet	masimo corporation	03/31/2023	QVT
DEN210039	SNOO Smart Sleeper	happiest baby, inc.	03/30/2023	QTG
DEN220030	RemeOs™ Screw LAG Solid	bioretec ltd.	03/29/2023	QJD
DEN220039	Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set	quidel corporation	03/08/2023	QVF
DEN210033	Lenire Tinnitus Treatment Device	neuromod devices limited	03/06/2023	QVN
DEN220065	Pill Sense System	enterasense ltd.	02/24/2023	QUD
DEN220063	Caption Interpretation Automated Ejection Fraction Software	caption health, inc	02/24/2023	QVD
DEN210022	PMD-200	medasense biometrics ltd.	02/17/2023	QVE
DEN220044	Active Anthrax DetectTM Plus Rapid Test	inbios international, inc.	02/03/2023	QUU
DEN220014	RefleXion Medical Radiotherapy System (RMRS)	reflexion medical inc	02/01/2023	QVA
DEN220017	BioXmark	nanovi a/s	12/23/2022	QUV
DEN220012	Tornier Pyrocarbon Humeral Head	tornier sas	12/16/2022	QKW
BR220737	SeCore CDx HLA Sequencing System	One Lambda, Inc.	11/28/2022	QUK
DEN200044	Eonis SCID-SMA Kit	perkinelmer inc.	11/09/2022	QUE
DEN220024	ScanNav Anatomy Peripheral Nerve Block	intelligent ultrasound limited	10/18/2022	QRG
DEN210027	The Cooral System	braincool ab	10/14/2022	QUA
DEN200067	INNOVANCE VWF Ac	siemens healthcare diagnostics products gmbh	09/29/2022	QTY
DEN220025	Phagenyx System	phagenesis limited	09/16/2022	QQG
DEN210052	Vibrant System	vibrant ltd.	08/26/2022	QTN
DEN210032	AccuMeasure System	rqmis inc.	07/26/2022	QTH
DEN210045	APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System	apollo endosurgery, inc.	07/12/2022	QTD
DEN210004	Zuno Smart Sterilization Container	zuno medical, inc.	06/17/2022	QJT
DEN220006	ProdiGI	covidien llc	06/13/2022	QSW
DEN200062	Parsortix PC1 Device	angle europe ltd.	05/24/2022	QSA
DEN210046	Quell-FM	neurometrix, inc.	05/18/2022	QSQ
DEN210044	CERAMENT G	bonesupport ab	05/17/2022	QRR
DEN200072	Lumipulse G Ss-amyloid Ratio (1-42/1-40)	fujirebio diagnostics, inc.	05/04/2022	QSE
DEN200063	Kerasave	al.chi.mi.a. s.r.l	05/02/2022	QCW
DEN200066	BioFire Joint Infection (JI) Panel	BioFire Diagnostics, LLC	04/29/2022	QSN
DEN200042	BrainTemp Neonate System (BTNeo System)	Brain Temp Inc.	03/29/2022	QSL
DEN210034	ONE Male Condom	Global Protection Corp.	02/23/2022	QRZ
DEN200059	POMC/PCSK1/LEPR CDx Panel	PreventionGenetics, LLC	01/21/2022	QRV
DEN210015	Sunrise Sleep Disorder Diagnostic Aid	Sunrise	01/07/2022	QRS
DEN210024	CavaClear Laser Sheath	Spectranetics, Inc.	12/21/2021	QRJ
DEN200041	Comfort Marker 2.0.	Medical Precision B.V.	12/10/2021	QRN
DEN200005	Klox Biophotonic LumiHeal System	Klox Technlogies Inc.	12/03/2021	QPE
DEN210012	Vpatch	Virility Medical	11/23/2021	QRC
DEN210014	EaseVRx	AppliedVR, Inc.	11/16/2021	QRA
DEN210006	Hemolung Respiratory Assist System	ALung Technologies, Inc.	11/13/2021	QOH
DEN200040	OMNIgene GUT Dx	DNA Genotek Inc.	11/03/2021	QPO
DEN210005	Luminopia One	Luminopia, Inc.	10/20/2021	QQU
DEN190055	Iotasoft Insertion System - Drive Unit, Controller And Accessories	IotaMotion, Inc.	10/01/2021	QQH
DEN200080	Paige Prostate	Paige.AI	09/21/2021	QPN
DEN200030	FEops HEARTguide	FEops NV	09/08/2021	QQI
DEN200064	Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System	Canary Medical, Inc.	08/27/2021	QPP
DEN210003	SureTune4 Software	Medtronic Neuromodulation	08/23/2021	QQC
DEN190056	ADVIA Centaur Enhanced Liver Fibrosis (ELF)	Siemens Healthcare Diagnostics Inc.	08/20/2021	QQB
DEN210013	OsteoProbe	Active Life Scientific, Inc.	08/19/2021	QGQ
DEN200039	InSpace Subacromial Tissue Spacer System	Ortho-Space Ltd.	07/12/2021	QPQ
DEN200069	Cognoa ASD Diagnosis Aid	Cognoa, Inc.	06/02/2021	QPF
DEN190043	SafeBreak Vascular	Site Saver, Inc. d/b/a Lineus Medical	05/27/2021	QOI
DEN200046	Neurolutions Upper Extremity Rehabilitation System	Neurolutions, Inc.	04/23/2021	QOL
DEN200055	GI Genius	Cosmo Artificial Intelligence - AI, LTD	04/09/2021	QNP
DEN200038	Gili Pro BioSensor (also Known As “Gili BioSensor System”)	ContinUse Biometrics Ltd.	04/01/2021	QOK
DEN200050	Portable Neuromodulation Stimulator (PoNS)	Helius Medical, Inc.	03/26/2021	QCF
DEN200019	Oxehealth Vital Signs	Oxehealth Limited	03/26/2021	QME
DEN200031	BioFire Respiratory Panel 2.1 (RP2.1)	Biofire Diagnostics, LLC	03/17/2021	QOF
DEN200006	ClearUP Sinus Relief	Tivic Health Systems Inc.	03/05/2021	QNU
DEN200022	Analytic For Hemodynamic Instability (AHI)	Fifth Eye Inc.	03/01/2021	QNV
DEN200017	Q-Collar	Q30 Sports Science, LLC	02/26/2021	QNX
DEN190022	Hominis Surgical System	Memic Innovative Surgery Ltd.	02/26/2021	QNM
DEN200028	Lumenis Stellar M22	Lumenis Ltd.	02/23/2021	QIU
DEN200018	Exciteosa With Remote And Exciteosa Without Remote	Signifier Medical Technologies	02/05/2021	QNO
DEN200016	EndoRotor Device	Interscope, Inc	12/23/2020	QNE
DEN190035	Helix Laboratory Platform	Helix OpCo, LLC	12/23/2020	QNC
DEN200035	BEAR (Bridge-Enhanced ACL Repair) Implant	Miach Orthopaedics, Inc.	12/16/2020	QNI
DEN200029	Parallel	Mahana Therapeutics, Inc.	11/25/2020	QMY
DEN190047	CADScor System	Acarix A/S	11/24/2020	QMW
DEN200043	FilmArray Global Fever Panel	BioFire Defense, LLC	11/20/2020	QMV
DEN190029	Acumen Assisted Fluid Management (AFM) Software Feature	Edwards Lifesciences	11/13/2020	QMS
DEN200033	NightWare Kit, Apple Iphone, Apple Watch, Apple Iphone Charging Cable, Apple Watch Charging Cable	NightWare, Inc	11/06/2020	QMZ
DEN200002	Tangible Boost	Tangible Science, Inc.	09/24/2020	QMM
DEN200010	Spineology Interbody Fusion System	Spineology, Inc.	09/18/2020	OQB
DEN190039	ToothWave™	Home Skinovations Ltd.	09/17/2020	QMJ
DEN190032	HemosIL Liquid Anti-Xa	Instrumentation Laboratory Co.	09/17/2020	QLU
DEN190042	Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer	Baxter Healthcare Corporation	08/28/2020	QAX
DEN200001	Cell-Free DNA BCT	Streck, Inc.	08/07/2020	QMA
DEN200015	Cobas EBV, Cobas EBV/BKV Control Kit, Cobas Buffer Negative Control Kit	Roche Molecular Systems, Inc.	07/30/2020	QLX
DEN200026	EndeavorRx	Akili Interactive Labs Inc.	06/15/2020	QFT
DEN190037	NaviCam Capsule Endoscope System With NaviCam Stomach Capsule	AnX Robotica, Inc.	05/22/2020	QKZ
DEN190031	NP Screen	Advance Sentry Corporation	05/11/2020	OJY
DEN190026	Itear Neurostimulator	Olympic Ophthalmics, Inc.	05/01/2020	QKV
DEN180065	OGmend Implant System	Woven Orthopedic Technologies, LLC	05/01/2020	QAC
DEN180055	CARPEDIEM System	Bellco srl (now part of Medtronic, Inc)	04/29/2020	QIR
DEN190028	MyCare Psychiatry Clozapine Assay Kit	Saladax Biomedical Inc	04/16/2020	QKT
DEN190020	Itind System	Medi-Tate Ltd.	02/25/2020	QKA
DEN190023	AmplideX Fragile X Dx & Carrier Screen Kit	Asuragen, Inc.	02/21/2020	OYV
DEN190038	Surfacer Inside-Out Access Catheter System	Bluegrass Vascular Technologies, Inc.	02/10/2020	QJH
DEN190040	Caption Guidance	Bay Labs, Inc.	02/07/2020	QJU
DEN180067	Mucosal Integrity Conductivity (MI) Test System	Diversatek Healthcare Inc.	12/23/2019	QIS
DEN190034	Control-IQ Technology	Tandem Diabetes Care, Inc.	12/13/2019	QJI
DEN180056	GSP Neonatal Creatine Kinase - MM Kit	PerkinElmer Inc.	12/12/2019	QJE
DEN190016	Cobas Vivodx MRSA	Roche Molecular Systems, Inc.	12/05/2019	QIV
DEN180014	WOUNDCHEK Bacterial Status	Alere Scarborough, Inc.	12/02/2019	QFA
DEN180062	EchoTip Insight Portosystemic Pressure Gradient Measuring System	Cook Ireland Ltd.	11/20/2019	QIJ
BR190330	Sentosa SQ HIV Genotyping Assay	Vela Diagnostics USA Inc	11/05/2019	QIC
DEN190025	OraQuick Ebola Rapid Antigen Test	OraSure Technologies, Inc.	10/10/2019	QID
DEN180057	IB-Stim	Innovative Health Solutions (IHS), Inc.	06/07/2019	QHH
DEN180069	ZIKV Detect 2.0 IgM Capture ELISA	InBios International, Inc.	05/23/2019	QFO
DEN180032	Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit	CD Diagnostics Inc.	05/23/2019	QGN
DEN180059	Nerivio Migra	Theranica Bioelectronics ltd	05/20/2019	QGT
DEN170064	Comaneci, Comaneci Petit, Comaneci 17	Rapid-Medical Ltd.	04/24/2019	PUU
DEN180041	Monarch Etns System	NeuroSigma, Inc	04/19/2019	QGL
DEN180013	PREVENA 125 And PREVENA PLUS 125 Therapy Units	KCI USA, Inc.	04/19/2019	QFC
DEN180060	Plenity	Gelesis, Inc.	04/12/2019	QFQ
DEN180024	Leica FL400	Leica Microsystems (Schweiz) AG	03/28/2019	QFX
DEN180012	LOADPRO™ Intraoperative Rod Strain Sensor	Intellirod Spine, Inc.	03/28/2019	QFP
DEN170044	ClearMate	Thornhill Research, Inc.	03/14/2019	QFB
DEN180017	Quantra Hemostasis Analyzer, QPlus Cartridge	HemoSonics, LLC	03/12/2019	QFR
DEN180021	Early Bird Bleed Monitoring System	Saranas, Inc.	03/01/2019	QFJ
DEN180058	T:slim X2 Insulin Pump With Interoperable Technology	Tandem Diabetes Care, Inc.	02/14/2019	QFG
DEN180047	Aptima Mycoplasma Genitalium Assay	Hologic, Inc.	01/23/2019	QEP
DEN170091	EyeBOX	Oculogica, Inc.	12/28/2018	QEA
DEN180007	Miris Human Milk Analyzer	Miris AB	12/21/2018	QEI
DEN170070	MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe K	Cytocell Ltd	12/21/2018	QDI
DEN170072	Enlight 1810	Timpel Inc.	12/20/2018	QEB
DEN170021	SEM Scanner (Model 200)	Bruin Biometrics, LLC	12/20/2018	QEF
DEN170055	Retrograde Intubation Set	Cook Incorporated	12/12/2018	QCX
DEN180040	Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit	Meridian Bioscience, Inc.	11/30/2018	QDZ
DEN180030	QMS Plazomicin Immunoassay	Microgenics Corporation	11/19/2018	QDR
DEN170049	Innovo	Bio-Medical Research Ltd.	11/06/2018	QAJ
DEN170092	Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System	Fluoptics	11/02/2018	QDG
DEN170056	Parathyroid Detection (Model PTeye) System	AiBiomed, Corp.	11/02/2018	QDF
DEN180028	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports	23andMe, Inc.	10/31/2018	QDJ
DEN180004	Picoamh ELISA	Ansh Labs LLC	10/24/2018	QDH
DEN180026	Bose Hearing Aid	Bose Corporation	10/05/2018	QDD
DEN170080	Adaptive Biotechnologies Clonoseq Assay	Adaptive Biotechnologies Corporation	09/28/2018	QDC
DEN070001	NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET	CENTERS FOR DISEASE CONTROL AND PREVENTION	09/21/2018	PBK
DEN180044	ECG App	Apple Inc	09/11/2018	QDA
DEN180042	Irregular Rhythm Notification Feature	Apple Inc	09/11/2018	QDB
DEN170090	MATRx Plus	Zephyr Sleep Technologies	08/23/2018	QCJ
DEN170078	Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System	Brainways Ltd.	08/17/2018	QCI
DEN170052	Natural Cycles	Natural Cycles Nordic AB	08/10/2018	PYT
DEN180008	MolecuLight I:x	MolecuLight Inc.	07/31/2018	QCR
DEN170009	Bonebridge	MED-EL Elektromedizinische Geraete GmbH	07/20/2018	PFO
DEN170004	Ellipsys Vascular Access System	Avenu Medical, Inc	06/22/2018	PQK
DEN160006	Everlinq Endoavf System	TVA Medical, Inc.	06/22/2018	PQK
DEN170043	DreaMed Advisor Pro	DreaMed Diabetes, Ltd.	06/12/2018	QCC
DEN170089	Curve Positive Airway Pressure System	FRESCA Medical	06/05/2018	QBY
DEN180005	OsteoDetect	Imagen Technologies, Inc.	05/24/2018	QBS
DEN170086	TrueTear Intranasal Tear Neurostimulator	Allergan	05/17/2018	QBR
DEN170015	Hemospray Endoscopic Hemostat	Wilson-Cook Medical, Inc	05/07/2018	QAU
DEN170028	Cala ONE	Cala Health, Inc.	04/26/2018	QBC
DEN170081	MALDI Biotyper CA System	Bruker Daltonik GmbH	04/20/2018	QBN
DEN170010	LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay	Lin-Zhi International, Inc.	04/20/2018	QBK
DEN180001	IDx-DR	IDx, LLC	04/11/2018	PIB
DEN170001	Precision Flow® HVNI	VAPOTHERM, INC.	04/10/2018	QAV
DEN170047	Curetis Unyvero LRT Application	Curetis GmbH	04/03/2018	QBH
DEN170088	Dexcom G6 Continuous Glucose Monitoring System	Dexcom, Inc.	03/27/2018	QBJ
DEN170023	ThermoNeuroModulation Device, TNM Device	Scion NeuroStim, LLC	03/26/2018	QAR
DEN170029	PrimeStore MTM	Longhorn Vaccines and Diagnostics LLC	03/19/2018	QBD
DEN160044	Acumen Hypotension Prediction Index (HPI) Feature Software	Edwards Lifesciences LLC	03/16/2018	QAQ
DEN170046	23andMe PGS Genetic Health Risk Report For BRCA1/BRCA2 (Selected Variants)	23andMe, Inc.	03/06/2018	QAZ
DEN160029	SkinPen Precision System	BELLUS MEDICAL, LLC.	03/01/2018	QAI
DEN170045	Banyan BTI	Banyan Biomarkers, Inc.	02/14/2018	QAT
DEN170073	ContaCT	Viz.Al, Inc.	02/13/2018	QAS
DEN160037	Dermapace System	SANUWAVE, INC.	12/28/2017	PZL
DEN160014	Remove System	OVESCO ENDOSCOPY AG	12/22/2017	QAG
DEN170024	AQUABEAM System	PROCEPT BioRobotics Corporation	12/21/2017	PZP
DEN170075	ContainOR	Advanced Surgical Concepts Ltd.	12/19/2017	PZQ
DEN160062	IlluminOss Bone Stabilization System	IllminOss Medical, Inc.	12/19/2017	QAD
DEN170041	GeneSTAT.MDx Coccidioides Assay	DxNA, LLC	11/29/2017	QAA
DEN170017	FilmArray Respiratory Panel 2 Plus (RP2plus)	BioFire Diagnostics, LLC	11/24/2017	PZF
DEN170058	MSK-IMPACT (Integrated Mutation Profiling Of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay	Memorial Sloan-Kettering Cancer Center	11/15/2017	PZM
DEN170018	NSS-2 System	Innovative Health Solutions (IHS), Inc.	11/15/2017	PZR
DEN170030	VENTANA Anti-mlh-1(m1) Mouse Monoclonal Primary Antibody, VENTANA Anti-pms2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA Anti-msh2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA Anti-msh6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA Anti-braf V600E (VE1) Mouse Monoclonal Primar	Ventana Medical Systems	10/27/2017	PZJ
DEN160018	Reset	PEAR THERAPEUTICS, INC.	09/14/2017	PWE
DEN160025	ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium Falciparum And P. Vivax Combo Test Kit	ID-FISH TECHNOLOGY, INC	08/18/2017	PYN
DEN150053	FETAL PILLOW	SAFE OBSTETRIC SYSTEMS LTD	07/27/2017	PWB
DEN170022	QuantX	Quantitative Insights, Inc	07/19/2017	POK
DEN160012	D2 Dressing	Z-MEDICA, LLC	06/30/2017	POD
DEN160047	ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M	Beckman Coulter	06/29/2017	PWD
DEN160040	Embosphere Microspheres	Biosphere Medical S.A.	06/21/2017	NOY
DEN160043	Sentinel Cerebral Protection System	Claret Medical, Inc.	06/01/2017	PUM
DEN170019	Vitamin D 200M Assay For The Topaz System	AB SCIEX LLC	05/18/2017	PSL
DEN160033	ARK Voriconazole II Assay Test System	ARK DIAGNOSTICS, INC	05/05/2017	PUJ
DEN160030	Oculeve Intranasal Tear Neurostimulator Device	OCULEVE, INC.	04/24/2017	PQJ
DEN150048	Gammacore Non-invasive Vagus Nerve Stimulator	electroCore, LLC	04/14/2017	PKR
DEN160056	Philips IntelliSite Pathology Solution	Philips Medical Systems Nederland B.V.	04/12/2017	PSY
DEN160026	23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia	23andMe, Inc.	04/06/2017	PTA
DEN160028	Ipsogen JAK2 RGQ PCR Kit	QIAGEN INC	03/27/2017	PSU
DEN160019	CINtec Histology (50 Tests), CINtec Histology (250 Tests)	VENTANA MEDICAL SYSTEMS, INC	03/04/2017	PRB
DEN160032	Accelerate Pheno System, Accelerate Phenotest BC Kit	ACCELERATE DIAGNOTICS	02/23/2017	PRH
DEN140033	Companion	LGCH, INC	02/16/2017	POS
DEN160048	FilmArray NGDS Warrior Panel	BioFire Defense, LLC	02/14/2017	PRD
DEN160016	Variola Virus Real-Time PCR Assay	CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)	02/06/2017	PRA
DEN150035	SEEKER System	Baebies, Inc.	02/03/2017	PQW
DEN160020	CipherOx CRI Tablet	Flashback Technologies, Inc.	12/21/2016	PPW
DEN150055	AeroForm Tissue Expander System	AIRXPANDERS, INC	12/21/2016	PQN
DEN150022	Ultravision Visual Clearing System	Alesi Surgical Ltd.	12/20/2016	PQM
DEN160005	Hem-Avert Perianal Stabilizer	STETRIX, INC.	12/19/2016	PNU
DEN150057	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	ROCHE DIAGNOSTICS	12/19/2016	PQO
DEN150038	CleanCisionTM Wound Retraction And Protection System	Prescient Surgical	12/16/2016	PQI
DEN160001	BD MAX Vaginal Panel, BD MAX Instrument	GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS)	10/28/2016	PQA
DEN150059	APAS Compact With Urine Analysis Module	CLEVER CULTURE SYSTEMS AG	10/06/2016	PPU
DEN150033	Sensor Monitored Alimentary Restriction Therapy (SMART) Device	SCIENTIFIC INTAKE	09/26/2016	ONY
DEN150056	Acclarent Aera Eustachian Tube Balloon Dilation System	ACCLARENT, INC.	09/16/2016	PNZ
DEN150049	Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm	CONCENTRIC MEDICAL, INC.	09/02/2016	POL
DEN150037	ImPACT Computerized Neurocognitive Concussion Management Aid	IMPACT APPLICATIONS, INC.	08/22/2016	POM
DEN140040	Nautilus BrainPulse 1000	JAN MEDICAL, INC.	08/01/2016	POP
DEN150029	Permaseal	MICRO INTERVENTIONAL DEVICES, INC.	07/27/2016	PNQ
DEN160003	Quantidex Qpcr BCR-ABL IS Kit	ASURAGEN, INC.	07/22/2016	OYX
DEN150004	EPIC ClearView System	EPIC RESEARCH & DIAGNOSTICS, INC.	07/15/2016	PNA
DEN150007	Magnetic Surgical System	Levita Magnetics International Corp.	06/13/2016	PNL
DEN130051	PEDIATRIC VISION SCANNER	REBISCAN, INC.	06/08/2016	PMW
DEN150040	WallFlex Biliary RX Fully Covered Stent System RMV	BOSTON SCIENTIFIC	06/03/2016	PNB
DEN140032	Cereve Sleep System	CEREVE, INC.	05/13/2016	PLU
DEN150030	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay	KRONUS, INC.	04/25/2016	PNI
DEN140022	GLAUCOMA COMPANION	INNOVATEX, INC.	04/20/2016	PLX
DEN150028	PneumoLiner	ADVANCED SURGICAL CONCEPTS LTD.	04/07/2016	PMU
DEN150058	Amplichek II, Negative And Amplichek II, Negative MiniPak, Amplichek II, Level 1 And Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 And Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 And Amplichek II, Level 3 MiniPak	Bio-Rad Laboratories	03/28/2016	PMN
DEN140017	SENSIMED TRIGGERFISH	SENSIMED AG	03/04/2016	PLZ
DEN150009	B.R.A.H.M.S PCT Sensitive KRYPTOR	B.R.A.H.M.S GMBH	02/20/2016	PMT
DEN140024	Cnep Airway	Sommetrics	12/23/2015	PMB
DEN150005	Newa Skin Therapy System	EndyMed Medical Ltd.	12/18/2015	PAY
DEN150010	Dignitana AB DigniCap System	DIGNITANA AB	12/08/2015	PMC
DEN150001	RELIZORB	ALCRESTA, INC.	11/20/2015	PLQ
DEN150008	INVOcell	INVO BIOSCIENCE	11/02/2015	OYO
DEN150011	Sonablate 450	SonaCare Medical, LLC.	10/09/2015	PLP
DEN150013	FilmArray Meningitis/Encephalitis(ME) Panel	BioFire Diagnostics, LLC	10/08/2015	PLO
DEN150002	EarLens Contact Hearing Device	EARLENS CORPORATION	09/29/2015	PLK
DEN140018	ESOPHAGEAL COOLING DEVICE	ADVANCED COOLING THERAPY, LLC	06/23/2015	PLA
DEN130039	BRAINPORT V100 DEVICE	WICAB, INC	06/18/2015	PIC
DEN130033	COGNIVUE	CEREBRAL ASSESSMENT SYSTEMS, INC	06/05/2015	PKQ
DEN140039	NOVA View Automated Fluorescense Microscope	INOVA DIAGNOSTICS, INC.	04/09/2015	PIV
DEN140030	SpaceOAR System	AUGMENIX , INC.	04/01/2015	OVB
DEN130047	PROLONG	ERGON MEDICAL LTD.	03/20/2015	PIA
DEN130046	REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE	SOMNA THERAPEUTICS, LLC	03/06/2015	PKA
DEN140044	23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)	23andMe	02/19/2015	PKB
DEN140020	ECLIPSE SYSTEM	PELVALON	02/12/2015	PJH
DEN140038	Dexcom Share Direct Secondary Displays	DEXCOM, INC.	01/23/2015	PJT
DEN140009	AMIGO REMOTE CATHETER SYSTEM	CATHETER ROBOTICS INC	12/18/2014	PJB
DEN130004	MOERAE SURGICAL MARKING PEN	MOERAE MATRIX, INC.	12/18/2014	PDW
DEN140010	PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM	WALLAC OY	12/15/2014	PJI
DEN130045	HEARTFLOW FFRCT	HEARTFLOW	11/26/2014	PJA
DEN140025	BrainScope Ahead 100	BRAINSCOPE COMPANY, INC	11/17/2014	PIW
DEN130019	ZANZA-CLICK	TECNIMED S.R.L.	11/07/2014	OSG
DEN100024	ZAP-IT!	ECOBRANDS LTD.	11/07/2014	OSG
DEN130044	INFLOW INTRAURETHRAL VALVE-PUMP	VESIFLO, INC.	10/14/2014	PIH
DEN140019	T2CANDIDA AND T2DX INSTRUMENT	T2 BIOSYSTEMS, INC	09/22/2014	PII
DEN130031	NEPHROCHECK TEST SYSTEM	ASTUTE MEDICAL, INC	09/05/2014	PIG
DEN120017	Medtronic DUET External Drainage And Monitoring System	MEDTRONIC NEUROSURGERY	08/22/2014	PCB
DEN140001	ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT	KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.	08/20/2014	PHF
DEN140016	STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE	DEXCOM, INC.	08/19/2014	PHV
DEN130034	REWALK	ARGO MEDICAL TECHNOLOGIES, INC.	06/26/2014	PHL
DEN120015	EEVA 2.0	AUXOGYN, INC.	06/06/2014	PBH
DEN140002	EUROIMMUN ANTI-PLA2R IFA	EUROIMMUN US	05/29/2014	PGV
DEN140004	QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY	DIAGNOSTIC HYBRIDS, INC.	05/13/2014	PGI
DEN130015	PIXEL 3 SYSTEM	GAUSS SURGICAL, INC.	05/09/2014	PBZ
DEN120016	DEKA ARM SYSTEM	DEKA INTEGRATED SOLUTIONS CORPORATION	05/09/2014	PAE
DEN140005	LYRA DIRECT STREP ASSAY	QUIDEL CORPORATION	04/16/2014	PGX
DEN130016	XSTAT	REVMEDX, INC.	04/03/2014	PGZ
DEN130040	IOGYN SYSTEM	IOGYN, INC.	03/28/2014	PGT
DEN130049	SIMPLEXA HSV 1&2 DIRECT	FOCUS DIAGNOSTICS	03/21/2014	PGH
DEN120019	CEFALY	STX-MED SPRL	03/11/2014	PCC
DEN080009	AIRPURGE	ANESTHESIA SAFETY PRODUCTS, LLC	03/04/2014	OKL
DEN120023	GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM	GIVEN IMAGING LTD.	01/29/2014	PGD
DEN130036	PROSTATE IMMOBILIZER RECTAL BALLOON	RADIADYNE	01/28/2014	PCT
DEN130018	CYTOSCAN(R) DX	Affymetrix, Inc.	01/17/2014	PFX
DEN130007	AXIOS STENT AND DELIVERY SYSTEM	XLUMENA, INC	12/18/2013	PCU
DEN110011	SYMPHONY DEVICE	SENSORY MEDICAL, INC	12/18/2013	OVP
DEN110009	RESTLESS LEG DEVICE	MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEEPER'S	12/18/2013	OTX
DEN130022	NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR	ENEURA THERAPEUTICS	12/13/2013	OKP
DEN130042	MISEQDX UNIVERSAL KIT 1.0	ILLUMINA, INC.	11/19/2013	PFT
DEN130011	ILLUMINA MISEQDX PLATFORM	ILLUMINA, INC.	11/19/2013	PFF
DEN130023	UROLIFT SYSTEM	NEOTRACT, INC.	09/13/2013	PEW
DEN130013	VITEK MS	BIOMERIEUX, INC.	08/21/2013	PEX
DEN130005	QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS	CENTERS FOR DISEASE CONTROL AND PREVENTION	08/08/2013	PDY
DEN130010	VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)	ABBOTT MOLECULAR, INC.	07/29/2013	PDO
DEN130032	XPERT MTB/RIF ASSAY	CEPHEID	07/25/2013	PEU
DEN110019	NEBA SYSTEM	LEXICOR MEDICAL TECHNOLOGY, LLC	07/15/2013	NCG
DEN110006	VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR	STERIS Corporation	07/12/2013	OWP
DEN110004	CABOCHON SYSTEM	CABOCHON AESTHETICS, INC.	07/12/2013	OUP
DEN130002	TINA-QUANT HBA1C GEN. 2 TEST SYSTEM	Roche Diagnostics	05/23/2013	PDJ
DEN120022	X-RAY ATTENUATING CREAM	BLOXR CORPORATION	05/09/2013	PDK
DEN130012	FERRISCAN R2-MRI ANALYSIS SYSTEM	RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	01/23/2013	PCS
DEN130003	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)	LUMINEX MOLECULAR DIAGNOSTICS, INC.	01/14/2013	PCH
DEN090007	BIO-SEAL LUNG BIOPSY TRACT SYSTEM	ANGIOTECH	12/19/2012	OMT
DEN100023	AHIP INTERNAL TRIGGER POINT WAND MODEL: 1	NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES,	11/20/2012	OSD
DEN090012	VIRULITE COLD SORE MACHINE	VIRULITE LLC	10/18/2012	OKJ
DEN120011	PROTEUS INGESTION CONFINMATION SYSTEMS	PROTEUS BIOMEDICAL, INC.	07/10/2012	OZW
DEN120014	VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)	NANOSPHERE, INC	06/26/2012	PAM
DEN080015	NUCLEUS-X PTV CATHETER	NUMED, INC.	06/11/2012	OZT
DEN120012	CDC DENV-1-4 REAL TIME RT-PCT ASSAY	CENTERS FOR DISEASE CONTROL AND PREVENTION	05/24/2012	OZB
DEN120013	PORTRAIT ANALYZER	GREAT BASIN SCIENTIFIC	04/30/2012	OMN
DEN110016	PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS	ETHICON ENDO-SURGERY	04/30/2012	OXT
DEN100016	PROSTATE MECHANICAL IMAGER	ARTANN LABORATORIES, INC	04/27/2012	OQT
DEN110002	SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT	STERIS Corporation	03/30/2012	OVY
DEN120001	IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE	PHADIA US INC.	02/15/2012	OYL
DEN120008	STRATIFY JCV(TM) ANTIBODY	FOCUS DIAGNOSTICS, INC.	01/20/2012	OYP
DEN100013	VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50	VIOGUARD	12/20/2011	OSZ
DEN100002	INFRASCANNER, MODEL 1000	INFRASCAN, INC.	12/13/2011	OPT
DEN100026	APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE	APTUS ENDOSYSTEMS, INC.	11/21/2011	OTD
DEN100017	LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)	TEARSCIENCE, INC.	06/28/2011	ORZ
DEN110012	APTIMA TRICHOMONAS VAGINALIS ASSAY	GEN-PROBE INCORPORATED	04/19/2011	OUY
DEN100020	DENV DETECT IGM CAPTURE ELISA	INBIOS INTL., INC.	04/08/2011	OSU
DEN100025	WIDEXLINK IN CLEAR SERIES HEARING AIDS	OFFICE RESEARCH IN CLINICAL AMPLIFICTION	03/31/2011	OSM
DEN070014	MANDOMETER III	AB MANDO	03/31/2011	OBV
DEN110001	RIDASCREEN NOROVIRUS 3RD GENERATION EIA	R-Biopharm AG	02/23/2011	OUC
DEN090011	HEM-AVERT PERIANAL STABILIZER	PLEXUS BIOMEDICAL INC.	01/13/2011	OOA
DEN090008	ERCHONIA ML SCANNER (MLS)	ERCHONIA MEDICAL	08/24/2010	OLI
DEN090002	ZELTIQ AESTHETICS DERMAL COOLING DEVICE	ZELTIQ AESTHETICS	08/24/2010	OOK
DEN090005	PRINEO SKIN CLOSURE SYSTEM	CLOSURE MEDICAL CORP.	04/30/2010	OMD
DEN090004	OVA1 TEST	VERMILLION	09/11/2009	ONX
DEN080006	ULTHERA SYSTEM, MODEL 8850-0001	ULTHERA, INC.	09/11/2009	OHV
DEN080011	SNAP WOUND CARE DEVICE	SPIRACUR, INC.	08/07/2009	OKO
DEN070002	QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING	QUICK-MED TECHNOLOGIES, INC.	02/25/2009	NYS
DEN070003	NEUROSTAR TMS SYSTEM	NEURONETICS	10/07/2008	OBP
DEN080007	ALLOMAP MOLECULAR EXPRESSION TESTING	XDX	08/26/2008	OJQ
DEN070013	ID-TAG RESPIRATORY VIRAL PANEL	LUMINEX MOLECULAR DIAGNOSTICS, INC.	01/03/2008	OCC
DEN070006	BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX	06/13/2007	OAX
DEN060002	INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM	INRANGE SYSTEMS, INC.	06/13/2007	NZH
DEN060009	3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR	3M COMPANY	05/08/2007	NZJ
DEN070004	XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065	CEPHEID	03/16/2007	OAI
DEN060003	TEPHAFLEX ABSORBABLE SUTURE	TEPHA, INC.	02/08/2007	NWJ
DEN070009	MAMMAPRINT	AGENDIA BV	02/06/2007	NYI
DEN060006	COMPUTERIZED LABOR MONITORING SYSTEM	BARNEV, LTD.	01/30/2007	NPB
BK060036	Sepax Cell Separation System And Single Use Kits	Biosafe SA	01/03/2007	OAO
DEN060007	INTROL CF PANEL I CONTROL	MAINE MOLECULAR QUALITY CONTROLS, INC.	10/12/2006	NZB
DEN060001	PHICAL TEST	GENOVA DIAGNOSTICS	04/26/2006	NXO
DEN050007	HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL	FMG INNOVATIONS, INC.	03/27/2006	NRK
DEN060008	INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET	CENTERS FOR DISEASE CONTROL AND PREVENTION	02/03/2006	NXD
DEN050006	CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM	CARDIOMEMS INC	10/28/2005	NQH
DEN050002	LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS	WAKO CHEMICALS, USA, INC.	05/19/2005	NSF
DEN050004	TAG-IT CYSTIC FIBROSIS KIT	TM BIOSCIENCE CORPORATION	05/09/2005	NUA
DEN050003	PAXGENE BLOOD RNA SYSTEM	PREANALYTIX GMBH	04/18/2005	NTW
DEN050001	DECAPINOL ORAL RINSE	SINCLAIR PHARMACEUTICALS LIMITED	04/18/2005	NTO
DEN040012	AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	Affymetrix, Inc.	12/23/2004	NSU
DEN040011	AMPLICHIP CYP450 TEST, MODEL 04381866190	ROCHE MOLECULAR SYSTEMS, INC.	12/23/2004	NTI
DEN040010	VYSIS AUTOVYSION SYSTEM	VYSIS	12/13/2004	NTH
DEN040009	HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)	HAMILTON THORNE BIOSCIENCES	11/04/2004	MRX
DEN040007	VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER	DIGITAL ANGEL CORPORATION	10/12/2004	NRV
DEN040002	NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970	PERKINELMER LIFE SCIENCES, INC.	08/24/2004	NQL
DEN040008	CEDIA SIROLIMUS ASSAY	MICROGENICS CORP.	07/28/2004	NRP
DEN040004	CELLERATION MIST THERAPY SYSTEM	CELLERATION	06/25/2004	NRB
DEN040003	GLUCATELL	ASSOCIATES OF CAPE COD, INC.	05/21/2004	NQZ
DEN040001	CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM	ADVANCED DIAGNOSTIC SYSTEMS	01/21/2004	NQI
DEN030005	FACTOR V LEIDEN KIT	ROCHE DIAGNOSTICS CORP.	12/17/2003	NPQ
DEN030004	WEST NILE VIRUS IGM CAPTURE ELISA	PANBIO LIMITED	07/08/2003	NOP
DEN030002	ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE	SPECTRAL DIAGNOSTICS, INC.	06/16/2003	NGS
DEN030001	NIOX ARTICLE NO: 02-1000	AEROCRINE AB	04/30/2003	MXA
DEN020001	BREASTVIEW VISUAL MAPPING SYSTEM	ASSURANCE MEDICAL	01/31/2003	NKA
DEN020003	RETROX	AURIC HEARING SYSTEMS, INC.	08/20/2002	NIX
DEN010002	GIVEN DIAGNOSTIC IMAGING SYSTEM	GIVEN IMAGING LTD.	08/01/2001	NEZ
BK000038	TrueGene HIV Genotyping Kit And OpenGene DNA Sequencing System	Visible Genetics, Inc.	06/27/2001	NHS
DEN000008	DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)	LIFE TECHNOLOGIES, INC.	02/16/2001	NDS
DEN000010	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	BIOSITE INCORPORATED	11/20/2000	NBC
DEN000007	QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA	INOVA DIAGNOSTICS, INC.	08/16/2000	NBT
DEN000006	EROS-CLITORAL THERAPY DEVICE (CTD)	UROMETRICS, INC.	04/28/2000	NBV
DEN000004	QUICKAIR CHOKE RELIEVER, MODEL 59-001A	MAET INDUSTRIES, INC.	02/29/2000	MZT
DEN990002	KAVO DIAGNODENT	KAVO AMERICA	02/22/2000	NBL
DEN990008	WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000	WALLAC, INC.	02/15/2000	NAK
DEN000002	UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE	UROSURGE, INC.	02/09/2000	NAM
DEN000001	OHMEDA INOVENT DELIVERY SYSTEM	OHMEDA MEDICAL	01/11/2000	MRN
DEN990005	THE 3PM EGG MACHINE	3PM CO., INC.	08/20/1999	MYE
DEN980003	DIAMOND PROBE/PERIO 2000 SYSTEM	DIAMOND GENERAL DEVELOPMENT CORP.	07/17/1998	MVH
DEN980001	DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND	CRANIAL TECHNOLOGIES, INC.	05/29/1998	MVA

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