|
|
|
Device Name
|
Requester
|
De Novo
Number
|
510(k)
Number
|
Decision
Date
|
|
QUICKAIR CHOKE RELIEVER, MODEL 59-001A
|
Maet Industries, Inc. |
DEN000004 |
K993284 |
02/29/2000 |
|
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO
|
Wallac, Inc. |
DEN990008 |
K992284 |
02/15/2000 |
|
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE
|
Urosurge, Inc. |
DEN000002 |
K992069 |
02/09/2000 |
|
THE 3PM EGG MACHINE
|
3pm Co., Inc. |
DEN990005 |
K984637 |
08/20/1999 |
|
KAVO DIAGNODENT
|
Kavo America |
DEN990002 |
K983658 |
02/22/2000 |
|
DIAMOND PROBE/PERIO 2000 SYSTEM
|
Diamond General Development Corp. |
DEN980003 |
K980749 |
07/17/1998 |
|
OHMEDA INOVENT DELIVERY SYSTEM
|
Ohmeda Medical |
DEN000001 |
K974562 |
01/11/2000 |
|
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC
|
Cranial Technologies, Inc. |
DEN980001 |
K964992 |
05/29/1998 |
|
LYRA DIRECT STREP ASSAY
|
Quidel Corporation |
DEN140005 |
K133883 |
04/16/2014 |
|
SIMPLEXA HSV 1&2 DIRECT
|
Focus Diagnostics |
DEN130049 |
K133621 |
03/21/2014 |
|
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASS
|
Diagnostic Hybrids, Inc. |
DEN140004 |
K133448 |
05/13/2014 |
|
MISEQDX UNIVERSAL KIT 1.0
|
Illumina, Inc. |
DEN130042 |
K133136 |
11/19/2013 |
|
IOGYN SYSTEM
|
Iogyn, Inc. |
DEN130040 |
K132695 |
03/28/2014 |
|
EUROIMMUN ANTI-PLA2R IFA
|
Euroimmun US |
DEN140002 |
K132379 |
05/29/2014 |
|
PROSTATE IMMOBILIZER RECTAL BALLOON
|
Radiadyne |
DEN130036 |
K132194 |
01/28/2014 |
|
REWALK
|
Argo Medical Technologies, Inc. |
DEN130034 |
K131798 |
06/26/2014 |
|
XPERT MTB/RIF ASSAY
|
Cepheid |
DEN130032 |
K131706 |
07/25/2013 |
|
UROLIFT SYSTEM
|
Neotract, Inc. |
DEN130023 |
K130651 |
09/13/2013 |
|
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC
|
Eneura Therapeutics |
DEN130022 |
K130556 |
12/13/2013 |
|
CYTOSCAN(R) DX
|
Affymetrix, Inc. |
DEN130018 |
K130313 |
01/17/2014 |
|
XSTAT
|
Revmedx, Inc. |
DEN130016 |
K130218 |
04/03/2014 |
|
PIXEL 3 SYSTEM
|
Gauss Surgical, Inc., |
DEN130015 |
K130190 |
05/09/2014 |
|
VITEK MS
|
Biomerieux, Inc. |
DEN130013 |
K124067 |
08/21/2013 |
|
FERRISCAN R2-MRI ANALYSIS SYSTEM
|
Resonance Health Analysis Services Pty, |
DEN130012 |
K124065 |
01/23/2013 |
|
ILLUMINA MISEQDX PLATFORM
|
Illumina, Inc. |
DEN130011 |
K123989 |
11/19/2013 |
|
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN
|
Abbott Molecular, Inc. |
DEN130010 |
K123951 |
07/29/2013 |
|
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY
|
Given Imaging , Ltd. |
DEN120023 |
K123666 |
01/29/2014 |
|
X-RAY ATTENUATING CREAM
|
Bloxr Corporation |
DEN120022 |
K123422 |
05/09/2013 |
|
AXIOS STENT AND DELIVERY SYSTEM
|
Xlumena, Inc. |
DEN130007 |
K123250 |
12/18/2013 |
|
CEFALY
|
Stx-Med Sprl |
DEN120019 |
K122566 |
03/11/2014 |
|
QUANTITATION OF ORGANOPHOSPHATE METABOL
|
Centers For Disease Control and Preventi |
DEN130005 |
K122282 |
08/08/2013 |
|
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP
|
Luminex Molecular Diagnostics, Inc. |
DEN130003 |
K121454 |
01/14/2013 |
|
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
|
Roche Diagnostics |
DEN130002 |
K121291 |
05/23/2013 |
|
DEKA ARM SYSTEM
|
Deka Integrated Solutions Corporation |
DEN120016 |
K121215 |
05/09/2014 |
|
EEVA 2.0
|
Auxogyn, Inc. |
DEN120015 |
K120427 |
06/06/2014 |
|
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC
|
Nanosphere, Inc. |
DEN120014 |
K113450 |
06/26/2012 |
|
PORTRAIT ANALYZER
|
Great Basin Scientific |
DEN120013 |
K113358 |
04/30/2012 |
|
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
|
Centers For Disease Control and Preventi |
DEN120012 |
K113336 |
05/24/2012 |
|
PROTEUS INGESTION CONFINMATION SYSTEMS
|
Proteus Biomedical, Inc. |
DEN120011 |
K113070 |
07/10/2012 |
|
NEBA SYSTEM
|
Lexicor Medical Technology, LLC |
DEN110019 |
K112711 |
07/15/2013 |
|
STRATIFY JCV(TM) ANTIBODY
|
Focus Diagnostics, Inc. |
DEN120008 |
K112394 |
01/20/2012 |
|
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10
|
Ethicon Endo-Surgery |
DEN110016 |
K110431 |
04/30/2012 |
|
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C
|
Phadia U.S., Inc. |
DEN120001 |
K103039 |
02/15/2012 |
|
APTIMA TRICHOMONAS VAGINALIS ASSAY
|
Gen-Probe Incorporated |
DEN110012 |
K102911 |
04/19/2011 |
|
SYMPHONY DEVICE
|
Sensory Medical, Inc. |
DEN110011 |
K102873 |
12/18/2013 |
|
RESTLESS LEG DEVICE
|
Mary M. Sorg (An Individual) Dba PJ Slee |
DEN110009 |
K102707 |
12/18/2013 |
|
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL
|
Steris Corporation |
DEN110006 |
K102469 |
07/12/2013 |
|
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR
|
Aptus Endosystems, Inc. |
DEN100026 |
K102333 |
11/21/2011 |
|
WIDEXLINK IN CLEAR SERIES HEARING AIDS
|
Office Research IN Clinical Amplifiction |
DEN100025 |
K101699 |
03/31/2011 |
|
CABOCHON SYSTEM
|
Cabochon Aesthetics, Inc. |
DEN110004 |
K101231 |
07/12/2013 |
|
AHIP INTERNAL TRIGGER POINT WAND MODEL:
|
National Center For Pelvic Pain Research |
DEN100023 |
K100934 |
11/20/2012 |
|
DENV DETECT IGM CAPTURE ELISA
|
Inbios Intl., Inc. |
DEN100020 |
K100534 |
04/08/2011 |
|
SYSTEM 1E PROCESS BIOLOGICAL MONITORING
|
Steris Corporation |
DEN110002 |
K100049 |
03/30/2012 |
|
LIPFLOW THERMAL PULSATION SYSTEM (FORMER
|
Tearscience, Inc. |
DEN100017 |
K093937 |
06/28/2011 |
|
PROSTATE MECHANICAL IMAGER
|
Artann Laboratories, Inc. |
DEN100016 |
K093579 |
04/27/2012 |
|
RIDASCREEN NOROVIRUS 3RD GENERATION EIA
|
R-Biopharm AG |
DEN110001 |
K093295 |
02/23/2011 |
|
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL
|
Vioguard |
DEN100013 |
K092996 |
12/20/2011 |
|
VIRULITE COLD SORE MACHINE
|
Virulite, LLC |
DEN090012 |
K083767 |
10/18/2012 |
|
HEM-AVERT PERIANAL STABILIZER
|
Plexus Biomedical, Inc. |
DEN090011 |
K083692 |
01/13/2011 |
|
NUCLEUS-X PTV CATHETER
|
Numed, Inc. |
DEN080015 |
K082776 |
06/11/2012 |
|
ERCHONIA ML SCANNER (MLS)
|
Erchonia Medical |
DEN090008 |
K082609 |
08/24/2010 |
|
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
|
Angiotech |
DEN090007 |
K082438 |
12/19/2012 |
|
PRINEO SKIN CLOSURE SYSTEM
|
Closure Medical Corp. |
DEN090005 |
K082289 |
04/30/2010 |
|
OVA1 TEST
|
Vermillion |
DEN090004 |
K081754 |
09/11/2009 |
|
SNAP WOUND CARE DEVICE
|
Spiracur, Inc. |
DEN080011 |
K081406 |
08/07/2009 |
|
AIRPURGE
|
Anesthesia Safety Products, LLC |
DEN080009 |
K080644 |
03/04/2014 |
|
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
|
Zeltiq Aesthetics |
DEN090002 |
K080521 |
08/24/2010 |
|
INFRASCANNER, MODEL 1000
|
Infrascan, Inc. |
DEN100002 |
K080377 |
12/13/2011 |
|
ALLOMAP MOLECULAR EXPRESSION TESTING
|
Xdx |
DEN080007 |
K073482 |
08/26/2008 |
|
ULTHERA SYSTEM, MODEL 8850-0001
|
Ulthera, Inc. |
DEN080006 |
K072505 |
09/11/2009 |
|
MANDOMETER III
|
Ab Mando |
DEN070014 |
K063817 |
03/31/2011 |
|
ID-TAG RESPIRATORY VIRAL PANEL
|
Luminex Molecular Diagnostics, Inc. |
DEN070013 |
K063765 |
01/03/2008 |
|
MAMMAPRINT
|
Agendia BV |
DEN070009 |
K062694 |
02/06/2007 |
|
3M N95 HOME RESPIRATOR WITH FLUID RESIST
|
3M Company |
DEN060009 |
K062070 |
05/08/2007 |
|
BINAX NOW MALARIA TEST; MODEL 660-000, 6
|
Inverness Medical Professional Diagnosti |
DEN070006 |
K061542 |
06/13/2007 |
|
XPERT EV, MODEL GXEV-100N-10; GENEXPERT
|
Cepheid |
DEN070004 |
K061062 |
03/16/2007 |
|
NEUROSTAR TMS SYSTEM
|
Neuronetics |
DEN070003 |
K061053 |
10/07/2008 |
|
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D
|
Quick-Med Technologies, Inc. |
DEN070002 |
K060662 |
02/25/2009 |
|
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA
|
Centers For Disease Control and Preventi |
DEN060008 |
K060159 |
02/03/2006 |
|
INTROL CF PANEL I CONTROL
|
Maine Molecular Quality Controls, Inc. |
DEN060007 |
K060070 |
10/12/2006 |
|
COMPUTERIZED LABOR MONITORING SYSTEM
|
Barnev, Ltd. |
DEN060006 |
K060028 |
01/30/2007 |
|
TEPHAFLEX ABSORBABLE SUTURE
|
Tepha, Inc. |
DEN060003 |
K052225 |
02/08/2007 |
|
HEALTHCHECK(TM) HOME TEST FOR LOSS OF TH
|
Fmg Innovations, Inc. |
DEN050007 |
K051653 |
03/27/2006 |
|
INRANGE REMOTE MEDICATION MANAGEMENT SYS
|
Inrange Systems, Inc. |
DEN060002 |
K051338 |
06/13/2007 |
|
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST
|
Cardiomems, Inc. |
DEN050006 |
K050939 |
10/28/2005 |
|
PHICAL TEST
|
Genova Diagnostics |
DEN060001 |
K050007 |
04/26/2006 |
|
TAG-IT CYSTIC FIBROSIS KIT
|
Tm Bioscience Corporation |
DEN050004 |
K043011 |
05/09/2005 |
|
PAXGENE BLOOD RNA SYSTEM
|
Preanalytix GmbH |
DEN050003 |
K042613 |
04/18/2005 |
|
AFFYMETRIX GENECHIP MICROARRAY INSTRUMEN
|
Affymetrix, Inc. |
DEN040012 |
K042279 |
12/23/2004 |
|
AMPLICHIP CYP450 TEST, MODEL 04381866190
|
Roche Molecular Systems, Inc. |
DEN040011 |
K042259 |
12/23/2004 |
|
VYSIS AUTOVYSION SYSTEM
|
Vysis |
DEN040010 |
K041875 |
12/13/2004 |
|
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L
|
Wako Chemicals USA, Inc. |
DEN050002 |
K041847 |
05/19/2005 |
|
DECAPINOL ORAL RINSE
|
Sinclair Pharmaceuticals Limited |
DEN050001 |
K041482 |
04/18/2005 |
|
HAMILTON THORNE ZONA INFRARED LASER OPTI
|
Hamilton Thorne Biosciences |
DEN040009 |
K040045 |
11/04/2004 |
|
CEDIA SIROLIMUS ASSAY
|
Microgenics Corp. |
DEN040008 |
K034069 |
07/28/2004 |
|
FACTOR V LEIDEN KIT
|
Roche Diagnostics Corp. |
DEN030005 |
K033607 |
12/17/2003 |
|
VERICHIP HEALTH INFORMATION MICROTRANSPO
|
Digital Angel Corporation |
DEN040007 |
K033440 |
10/12/2004 |
|
CELLERATION MIST THERAPY SYSTEM
|
Celleration |
DEN040004 |
K032378 |
06/25/2004 |
|
GLUCATELL
|
Associates OF Cape Cod, Inc. |
DEN040003 |
K032373 |
05/21/2004 |
|
NEOGRAM AMINO ACIDS AND ACYLCARNITINES T
|
Perkinelmer Life Sciences, Inc. |
DEN040002 |
K031878 |
08/24/2004 |
|
WEST NILE VIRUS IGM CAPTURE ELISA
|
Panbio Limited |
DEN030004 |
K031703 |
07/08/2003 |
|
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI
|
Advanced Diagnostic Systems |
DEN040001 |
K031588 |
01/21/2004 |
|
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
|
Spectral Diagnostics, Inc. |
DEN030002 |
K021885 |
06/16/2003 |
|
NIOX ARTICLE NO: 02-1000
|
Aerocrine AB |
DEN030001 |
K021133 |
04/30/2003 |
|
RETROX
|
Auric Hearing Systems, Inc. |
DEN020003 |
K013298 |
08/20/2002 |
|
BREASTVIEW VISUAL MAPPING SYSTEM
|
Assurance Medical |
DEN020001 |
K010514 |
01/31/2003 |
|
GIVEN DIAGNOSTIC IMAGING SYSTEM
|
Given Imaging , Ltd. |
DEN010002 |
K010312 |
08/01/2001 |
|
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP)
|
Biosite Incorporated |
DEN000010 |
K003475 |
11/20/2000 |
|
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
|
Life Technologies, Inc. |
DEN000008 |
K001447 |
02/16/2001 |
|
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI
|
Inova Diagnostics, Inc. |
DEN000007 |
K000732 |
08/16/2000 |
|
EROS-CLITORAL THERAPY DEVICE (CTD)
|
Urometrics, Inc. |
DEN000006 |
K000280 |
04/28/2000 |
|
Sepax Cell Separation System and Single
|
Biosafe SA |
|
BK060036 |
01/03/2007 |
|
TrueGene HIV Genotyping Kit and OpenGene
|
Visible Genetics, Inc. |
|
BK000038 |
06/27/2001 |
|
Rho
|
16 Bit, Inc. |
DEN230023 |
|
04/09/2024 |
|
23ANDME PERSONAL GENOME SERVICE (HEREINA
|
23AndMe |
DEN140044 |
|
02/19/2015 |
|
23andMe Personal Genome Service (PGS) Ge
|
23AndMe, Inc. |
DEN160026 |
|
04/06/2017 |
|
23andMe PGS Genetic Health Risk Report f
|
23AndMe, Inc. |
DEN170046 |
|
03/06/2018 |
|
23andMe Personal Genome Service (PGS) Ph
|
23AndMe, Inc. |
DEN180028 |
|
10/31/2018 |
|
3M™ Attest™ eBowie-Dick Test Card 10135
|
3M Company |
DEN230068 |
|
05/21/2024 |
|
Vitamin D 200M Assay for the Topaz Syste
|
Ab Sciex, LLC |
DEN170019 |
|
05/18/2017 |
|
CADScor System
|
Acarix A/S |
DEN190047 |
|
11/24/2020 |
|
Accelerate Pheno system, Accelerate Phen
|
Accelerate Diagnotics |
DEN160032 |
|
02/23/2017 |
|
Acclarent Aera Eustachian Tube Balloon D
|
Acclarent, Inc. |
DEN150056 |
|
09/16/2016 |
|
OsteoProbe
|
Active Life Scientific, Inc. |
DEN210013 |
|
08/19/2021 |
|
Tango® Belt (Model SAS-001-01 (XS); Mode
|
Active Protective Technologies, Inc. |
DEN240021 |
|
04/09/2025 |
|
Adaptive Biotechnologies clonoSEQ Assay
|
Adaptive Biotechnologies Corporation |
DEN170080 |
|
09/28/2018 |
|
NP Screen
|
Advance Sentry Corporation |
DEN190031 |
|
05/11/2020 |
|
ensoETM
|
Advanced Cooling Therapy, Inc. D/B/A Att |
DEN230021 |
|
09/13/2023 |
|
ESOPHAGEAL COOLING DEVICE
|
Advanced Cooling Therapy, LLC |
DEN140018 |
|
06/23/2015 |
|
PneumoLiner
|
Advanced Surgical Concepts, Ltd. |
DEN150028 |
|
04/07/2016 |
|
ContainOR
|
Advanced Surgical Concepts, Ltd. |
DEN170075 |
|
12/19/2017 |
|
Parathyroid Detection (Model PTeye) Syst
|
Aibiomed, Corp. |
DEN170056 |
|
11/02/2018 |
|
AeroForm Tissue Expander System
|
Airxpanders, Inc. |
DEN150055 |
|
12/21/2016 |
|
EndeavorRx
|
Akili Interactive Labs, Inc. |
DEN200026 |
|
06/15/2020 |
|
Kerasave
|
Al.Chi.Mi.A. S.R.L |
DEN200063 |
|
05/02/2022 |
|
RELIZORB
|
Alcresta, Inc. |
DEN150001 |
|
11/20/2015 |
|
WOUNDCHEK Bacterial Status
|
Alere Scarborough, Inc. |
DEN180014 |
|
12/02/2019 |
|
Ultravision Visual Clearing System
|
Alesi Surgical, Ltd. |
DEN150022 |
|
12/20/2016 |
|
TrueTear Intranasal Tear Neurostimulator
|
Allergan |
DEN170086 |
|
05/17/2018 |
|
Hemolung Respiratory Assist System
|
Alung Technologies, Inc. |
DEN210006 |
|
11/13/2021 |
|
Parsortix PC1 Device
|
Angle Europe , Ltd. |
DEN200062 |
|
05/24/2022 |
|
NaviCam ProScan
|
Ankon Technologies Co., Ltd. |
DEN230027 |
|
12/12/2023 |
|
picoAMH ELISA
|
Ansh Labs, LLC |
DEN180004 |
|
10/24/2018 |
|
NaviCam Capsule Endoscope System with Na
|
Anx Robotica, Inc. |
DEN190037 |
|
05/22/2020 |
|
APOLLO ESG System, APOLLO ESG SX System,
|
Apollo Endosurgery, Inc. |
DEN210045 |
|
07/12/2022 |
|
Irregular Rhythm Notification Feature
|
Apple, Inc. |
DEN180042 |
|
09/11/2018 |
|
ECG App
|
Apple, Inc. |
DEN180044 |
|
09/11/2018 |
|
Hearing Aid Feature (HAF)
|
Apple, Inc. |
DEN230081 |
|
09/12/2024 |
|
EaseVRx
|
Appliedvr, Inc. |
DEN210014 |
|
11/16/2021 |
|
ARK Voriconazole II Assay Test System
|
Ark Diagnostics, Inc. |
DEN160033 |
|
05/05/2017 |
|
ArteraAI Prostate
|
Artera, Inc. |
DEN240068 |
|
07/31/2025 |
|
NEPHROCHECK TEST SYSTEM
|
Astute Medical, Inc. |
DEN130031 |
|
09/05/2014 |
|
Quantidex qPCR BCR-ABL IS Kit
|
Asuragen, Inc. |
DEN160003 |
|
07/22/2016 |
|
AmplideX Fragile X Dx & Carrier Screen K
|
Asuragen, Inc. |
DEN190023 |
|
02/21/2020 |
|
SpaceOAR System
|
Augmenix, Inc. |
DEN140030 |
|
04/01/2015 |
|
Ellipsys Vascular Access System
|
Avenu Medical, Inc. |
DEN170004 |
|
06/22/2018 |
|
SEEKER System
|
Baebies, Inc. |
DEN150035 |
|
02/03/2017 |
|
FSYX™ Ocular Pressure Adjusting Pump (FS
|
Balance Ophthalmics, Inc. |
DEN230055 |
|
06/27/2024 |
|
Banyan BTI
|
Banyan Biomarkers, Inc. |
DEN170045 |
|
02/14/2018 |
|
Theranova Dialyzers, Theranova 400 Dialy
|
Baxter Healthcare Corporation |
DEN190042 |
|
08/28/2020 |
|
Caption Guidance
|
Bay Labs, Inc. |
DEN190040 |
|
02/07/2020 |
|
ClearLLab T1, ClearLLab T2, ClearLLab B1
|
Beckman Coulter |
DEN160047 |
|
06/29/2017 |
|
CARPEDIEM System
|
Bellco Srl (Now Part OF Medtronic, Inc) |
DEN180055 |
|
04/29/2020 |
|
SkinPen Precision System
|
Bellus Medical, LLC |
DEN160029 |
|
03/01/2018 |
|
BT-001
|
Better Therapeutics |
DEN220058 |
|
07/07/2023 |
|
Innovo
|
Bio-Medical Research, Ltd. |
DEN170049 |
|
11/06/2018 |
|
Amplichek II, Negative and Amplichek II,
|
Bio-Rad Laboratories |
DEN150058 |
|
03/28/2016 |
|
FilmArray NGDS Warrior Panel
|
Biofire Defense, LLC |
DEN160048 |
|
02/14/2017 |
|
FilmArray Global Fever Panel
|
Biofire Defense, LLC |
DEN200043 |
|
11/20/2020 |
|
FilmArray Meningitis/Encephalitis(ME) Pa
|
Biofire Diagnostics, LLC |
DEN150013 |
|
10/08/2015 |
|
FilmArray Respiratory Panel 2 plus (RP2p
|
Biofire Diagnostics, LLC |
DEN170017 |
|
11/24/2017 |
|
BioFire Respiratory Panel 2.1 (RP2.1)
|
Biofire Diagnostics, LLC |
DEN200031 |
|
03/17/2021 |
|
BioFire Joint Infection (JI) Panel
|
Biofire Diagnostics, LLC |
DEN200066 |
|
04/29/2022 |
|
Biolinq Shine Autonomous Time-in-Range M
|
Biolinq Incorporated |
DEN240080 |
|
09/23/2025 |
|
RemeOs™ Screw LAG Solid
|
Bioretec , Ltd. |
DEN220030 |
|
03/29/2023 |
|
Embosphere Microspheres
|
Biosphere Medical, S.A. |
DEN160040 |
|
06/21/2017 |
|
Surfacer Inside-Out Access Catheter Syst
|
Bluegrass Vascular Technologies, Inc. |
DEN190038 |
|
02/10/2020 |
|
Revi System
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Bluewind Medical , Ltd. |
DEN220073 |
|
08/16/2023 |
|
Osteoboost Belt
|
Bone Health Technologies, Inc. |
DEN230015 |
|
01/12/2024 |
|
CERAMENT G
|
Bonesupport AB |
DEN210044 |
|
05/17/2022 |
|
Bose Hearing Aid
|
Bose Corporation |
DEN180026 |
|
10/05/2018 |
|
WallFlex Biliary RX Fully Covered Stent
|
Boston Scientific |
DEN150040 |
|
06/03/2016 |
|
AXIOS Stent and Electrocautery-Enhanced
|
Boston Scientific Corporation |
DEN230019 |
|
08/18/2023 |
|
BrachyGel Vaginal Hydrogel Packing Syste
|
Brachyfoam, Inc. D/B/A Advaray |
DEN220052 |
|
08/22/2023 |
|
B.R.A.H.M.S PCT sensitive KRYPTOR
|
Brahms GmbH |
DEN150009 |
|
02/20/2016 |
|
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy
|
Brahms GmbH, Part OF Thermo Fisher Scien |
DEN220027 |
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05/18/2023 |
|
BrainTemp Neonate System (BTNeo System)
|
Brain Temp, Inc. |
DEN200042 |
|
03/29/2022 |
|
The Cooral System
|
Braincool AB |
DEN210027 |
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10/14/2022 |
|
BrainScope Ahead 100
|
Brainscope Company, Inc. |
DEN140025 |
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11/17/2014 |
|
Brainsway Deep Transcranial Magnetic Sti
|
Brainways , Ltd. |
DEN170078 |
|
08/17/2018 |
|
SEM Scanner (Model 200)
|
Bruin Biometrics, LLC |
DEN170021 |
|
12/20/2018 |
|
MALDI Biotyper CA System
|
Bruker Daltonik GmbH |
DEN170081 |
|
04/20/2018 |
|
Cala ONE
|
Cala Health, Inc. |
DEN170028 |
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04/26/2018 |
|
Canary Tibial Extension with Canary Heal
|
Canary Medical, Inc. |
DEN200064 |
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08/27/2021 |
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The N-SWEAT Patch
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Candesant Biomedical, Inc. |
DEN210055 |
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04/07/2023 |
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Caption Interpretation Automated Ejectio
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Caption Health, Inc. |
DEN220063 |
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02/24/2023 |
|
AMIGO REMOTE CATHETER SYSTEM
|
Catheter Robotics, Inc. |
DEN140009 |
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12/18/2014 |
|
Synovasure Alpha Defensin Lateral Flow T
|
Cd Diagnostics, Inc. |
DEN180032 |
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05/23/2019 |
|
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR
|
Centers For Disease Control and Preventi |
DEN070001 |
|
09/21/2018 |
|
Variola virus Real-Time PCR Assay
|
Centers For Disease Control and Preventi |
DEN160016 |
|
02/06/2017 |
|
Xpert HCV; GeneXpert Xpress System
|
Cepheid |
DEN240016 |
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06/27/2024 |
|
COGNIVUE
|
Cerebral Assessment Systems, Inc. |
DEN130033 |
|
06/05/2015 |
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Cereve Sleep System
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Cereve, Inc. |
DEN140032 |
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05/13/2016 |
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Allix5
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Clairity, Inc. |
DEN240047 |
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05/30/2025 |
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Sentinel Cerebral Protection System
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Claret Medical, Inc. |
DEN160043 |
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06/01/2017 |
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SmartFlow Neuro Cannula
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Clearpoint Neuro, Inc. |
DEN240023 |
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11/13/2024 |
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APAS Compact with Urine Analysis Module
|
Clever Culture Systems AG |
DEN150059 |
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10/06/2016 |
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CT-132
|
Click Therapeutics, Inc. |
DEN240064 |
|
04/11/2025 |
|
Versius Surgical System
|
Cmr Surgical Limited |
DEN230078 |
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10/11/2024 |
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Cognoa ASD Diagnosis Aid
|
Cognoa, Inc. |
DEN200069 |
|
06/02/2021 |
|
Modified Trevo ProVue Retriever, Trevo X
|
Concentric Medical, Inc. |
DEN150049 |
|
09/02/2016 |
|
Gili Pro BioSensor (also known as “Gili
|
Continuse Biometrics , Ltd. |
DEN200038 |
|
04/01/2021 |
|
Retrograde Intubation Set
|
Cook Incorporated |
DEN170055 |
|
12/12/2018 |
|
EchoTip Insight Portosystemic Pressure G
|
Cook Ireland, Ltd. |
DEN180062 |
|
11/20/2019 |
|
GI Genius
|
Cosmo Artificial Intelligence - Ai, Ltd. |
DEN200055 |
|
04/09/2021 |
|
ProdiGI
|
Covidien, LLC |
DEN220006 |
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06/13/2022 |
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Cue COVID-19 Molecular Test
|
Cue Health, Inc. |
DEN220028 |
|
06/06/2023 |
|
Curetis Unyvero LRT Application
|
Curetis GmbH |
DEN170047 |
|
04/03/2018 |
|
KMT2A Breakapart FISH Probe Kit PDx (CDA
|
Cytocell Limited |
DEN240067 |
|
09/19/2025 |
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MLL (KMT2A) Breakapart FISH Probe Kit; A
|
Cytocell, Ltd. |
DEN170070 |
|
12/21/2018 |
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BrainSee
|
Darmiyan, Inc. |
DEN220066 |
|
01/11/2024 |
|
DentalMonitoring
|
Dental Monitoring Sas |
DEN230035 |
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05/17/2024 |
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DermaSensor
|
Dermasensor, Inc. |
DEN230008 |
|
01/12/2024 |
|
STUDIO ON THE CLOUD DATA MANAGEMENT SOFT
|
Dexcom, Inc. |
DEN140016 |
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08/19/2014 |
|
Dexcom Share Direct Secondary Displays
|
Dexcom, Inc. |
DEN140038 |
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01/23/2015 |
|
Dexcom G6 Continuous Glucose Monitoring
|
Dexcom, Inc. |
DEN170088 |
|
03/27/2018 |
|
Simplexa C. auris Direct, Simplexa C. au
|
Diasorin Molecular, LLC |
DEN230092 |
|
07/15/2024 |
|
Dignitana AB DigniCap System
|
Dignitana AB |
DEN150010 |
|
12/08/2015 |
|
Dexter L6 System
|
Distalmotion SA |
DEN230084 |
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10/25/2024 |
|
Mucosal Integrity Conductivity (MI) Test
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Diversatek Healthcare, Inc. |
DEN180067 |
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12/23/2019 |
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OMNIgene GUT Dx
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Dna Genotek, Inc. |
DEN200040 |
|
11/03/2021 |
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DreaMed Advisor Pro
|
Dreamed Diabetes , Ltd. |
DEN170043 |
|
06/12/2018 |
|
GeneSTAT.MDx Coccidioides Assay
|
Dxna, LLC |
DEN170041 |
|
11/29/2017 |
|
EarLens Contact Hearing Device
|
Earlens Corporation |
DEN150002 |
|
09/29/2015 |
|
ZAP-IT!
|
Ecobrands , Ltd. |
DEN100024 |
|
11/07/2014 |
|
Acumen Assisted Fluid Management (AFM) S
|
Edwards Lifesciences |
DEN190029 |
|
11/13/2020 |
|
Acumen Hypotension Prediction Index (HPI
|
Edwards Lifesciences, LLC |
DEN160044 |
|
03/16/2018 |
|
gammaCore Non-invasive Vagus Nerve Stimu
|
Electrocore, LLC |
DEN150048 |
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04/14/2017 |
|
Newa Skin Therapy System
|
Endymed Medical, Ltd. |
DEN150005 |
|
12/18/2015 |
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Pill Sense System
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Enterasense , Ltd. |
DEN220065 |
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02/24/2023 |
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Minder System
|
Epi-Minder Pty, Ltd. |
DEN240062 |
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04/17/2025 |
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EPIC ClearView System
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Epic Research & Diagnostics, Inc. |
DEN150004 |
|
07/15/2016 |
|
PROLONG
|
Ergon Medical , Ltd. |
DEN130047 |
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03/20/2015 |
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Essilor® Stellest®
|
Essilor OF America, Inc. |
DEN250016 |
|
09/25/2025 |
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FEops HEARTguide
|
Feops NV |
DEN200030 |
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09/08/2021 |
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Analytic for Hemodynamic Instability (AH
|
Fifth Eye, Inc. |
DEN200022 |
|
03/01/2021 |
|
APO-Easy Genotyping kit
|
Firalis SA |
DEN240032 |
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06/12/2025 |
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Body Temperature Software (BTS)
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Fitbit, LLC |
DEN230050 |
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12/15/2023 |
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CipherOx CRI Tablet
|
Flashback Technologies, Inc. |
DEN160020 |
|
12/21/2016 |
|
Fluobeam 800 Clinic Imaging Device used
|
Fluoptics |
DEN170092 |
|
11/02/2018 |
|
Curve Positive Airway Pressure System
|
Fresca Medical |
DEN170089 |
|
06/05/2018 |
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Lumipulse G ß-Amyloid Ratio (1-42/1-40)
|
Fujirebio Diagnostics,Inc. |
DEN200072 |
|
05/04/2022 |
|
Neurolyser XR (NXR100)
|
Fusmobile, Inc. |
DEN250015 |
|
11/14/2025 |
|
Eroxon
|
Futura Medical Developments Limited |
DEN220078 |
|
06/09/2023 |
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Oxiplex®
|
Fziomed, Inc. |
DEN240038 |
|
06/17/2025 |
|
Galen ES Cooperative Surgical Assistant
|
Galen Robotics |
DEN220047 |
|
07/19/2023 |
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Breast Implant Removal Device (BIRD)
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Gaylord Solutions, LLC |
DEN220082 |
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04/20/2023 |
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Plenity
|
Gelesis, Inc. |
DEN180060 |
|
04/12/2019 |
|
BD MAX Vaginal Panel, BD MAX Instrument
|
Geneohm Sciences Canada, Inc. (Bd Diagno |
DEN160001 |
|
10/28/2016 |
|
Chronos®
|
Germitec |
DEN230067 |
|
08/28/2024 |
|
ONE Male Condom
|
Global Protection Corp. |
DEN210034 |
|
02/23/2022 |
|
MagDI System
|
Gt Metabolic Solutions, Inc. |
DEN240013 |
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07/02/2024 |
|
SNOO Smart Sleeper
|
Happiest Baby, Inc. |
DEN210039 |
|
03/30/2023 |
|
Healgen Rapid Check COVID-19/Flu A&B Ant
|
Healgen |
DEN240029 |
|
10/07/2024 |
|
HEARTFLOW FFRCT
|
Heartflow |
DEN130045 |
|
11/26/2014 |
|
Portable Neuromodulation Stimulator (PoN
|
Helius Medical, Inc. |
DEN200050 |
|
03/26/2021 |
|
Helix Laboratory Platform
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Helix Opco, LLC |
DEN190035 |
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12/23/2020 |
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Hemanext ONE
|
Hemanext, Inc. |
BR220665 |
|
09/15/2023 |
|
Quantra Hemostasis Analyzer, QPlus Cartr
|
Hemosonics, LLC |
DEN180017 |
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03/12/2019 |
|
Edison System
|
Histosonics, Inc. |
DEN220087 |
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10/06/2023 |
|
Aptima Mycoplasma genitalium Assay
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Hologic, Inc. |
DEN180047 |
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01/23/2019 |
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“Genius™ Digital Diagnostics System with
|
Hologic, Inc. |
DEN210035 |
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01/31/2024 |
|
ToothWave™
|
Home Skinovations , Ltd. |
DEN190039 |
|
09/17/2020 |
|
ProSense™ System
|
Icecure Medical |
DEN220077 |
|
10/03/2025 |
|
ID-FISH Plasmodium Genus Test Kit, ID-FI
|
Id-Fish Technology, Inc. |
DEN160025 |
|
08/18/2017 |
|
IDx-DR
|
Idx, LLC |
DEN180001 |
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04/11/2018 |
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IlluminOss Bone Stabilization System
|
Illminoss Medical, Inc. |
DEN160062 |
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12/19/2017 |
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OsteoDetect
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Imagen Technologies, Inc. |
DEN180005 |
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05/24/2018 |
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ImPACT Computerized Neurocognitive Concu
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Impact Applications, Inc. |
DEN150037 |
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08/22/2016 |
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Fibresolve
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Imvaria, Inc. |
DEN220040 |
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01/12/2024 |
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ZIKV Detect 2.0 IgM Capture ELISA
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Inbios International, Inc. |
DEN180069 |
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05/23/2019 |
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Active Anthrax DetectTM Plus Rapid Test
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Inbios International, Inc. |
DEN220044 |
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02/03/2023 |
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GLAUCOMA COMPANION
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Innovatex, Inc. |
DEN140022 |
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04/20/2016 |
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NSS-2 System
|
Innovative Health Solutions (Ihs), Inc. |
DEN170018 |
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11/15/2017 |
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IB-Stim
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Innovative Health Solutions (Ihs), Inc. |
DEN180057 |
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06/07/2019 |
|
NOVA View Automated Fluorescense Microsc
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Inova Diagnostics, Inc. |
DEN140039 |
|
04/09/2015 |
|
HemosIL Liquid Anti-Xa
|
Instrumentation Laboratory CO |
DEN190032 |
|
09/17/2020 |
|
ScanNav Anatomy Peripheral Nerve Block
|
Intelligent Ultrasound Limited |
DEN220024 |
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10/18/2022 |
|
LOADPRO™ Intraoperative Rod Strain Senso
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Intellirod Spine, Inc. |
DEN180012 |
|
03/28/2019 |
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EndoRotor Device
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Interscope, Inc. |
DEN200016 |
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12/23/2020 |
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VerTouch Spinal Imaging Device
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Intuitap Medical, Inc. |
DEN220009 |
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01/19/2024 |
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Neoasis
|
Invictus Medical, Inc. |
DEN220048 |
|
06/16/2023 |
|
Invitae Common Hereditary Cancers Panel
|
Invitae Corporation |
DEN210011 |
|
09/29/2023 |
|
INVOcell
|
Invo Bioscience |
DEN150008 |
|
11/02/2015 |
|
iotaSOFT Insertion System - Drive Unit,
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Iotamotion, Inc. |
DEN190055 |
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10/01/2021 |
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Nautilus BrainPulse 1000
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Jan Medical, Inc. |
DEN140040 |
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08/01/2016 |
|
PREVENA 125 and PREVENA PLUS 125 Therapy
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Kci USA, Inc. |
DEN180013 |
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04/19/2019 |
|
Klox Biophotonic LumiHeal System
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Klox Technlogies, Inc. |
DEN200005 |
|
12/03/2021 |
|
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI
|
Kronus Market Development Associates, In |
DEN140001 |
|
08/20/2014 |
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KRONUS Aquaporin-4 Autoantibody (AQP4Ab)
|
Kronus, Inc. |
DEN150030 |
|
04/25/2016 |
|
VasQ
|
Laminate Medical Technologies , Ltd. |
DEN220026 |
|
09/26/2023 |
|
Leica FL400
|
Leica Microsystems (Schweiz) AG |
DEN180024 |
|
03/28/2019 |
|
Simple 2 Test
|
Letsgetchecked Inc. (Formerly Privapath |
DEN200070 |
|
11/15/2023 |
|
Magnetic Surgical System
|
Levita Magnetics International Corp |
DEN150007 |
|
06/13/2016 |
|
Companion
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Lgch, Inc. |
DEN140033 |
|
02/16/2017 |
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LZI Carisoprodol Metabolite (Meprobamate
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Lin-Zhi International, , Inc. |
DEN170010 |
|
04/20/2018 |
|
PrimeStore MTM
|
Longhorn Vaccines and Diagnostics, LLC |
DEN170029 |
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03/19/2018 |
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Mi-CHORD System
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Lsi Solutions, Inc. |
DEN230069 |
|
06/11/2024 |
|
Lumenis Stellar M22
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Lumenis, Ltd. |
DEN200028 |
|
02/23/2021 |
|
Luminopia One
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Luminopia, Inc. |
DEN210005 |
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10/20/2021 |
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Valeda Light Delivery System
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Lumithera, Inc. |
DEN230083 |
|
11/04/2024 |
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Parallel
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Mahana Therapeutics, Inc. |
DEN200029 |
|
11/25/2020 |
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DuraGraft
|
Marizyme, Inc. |
DEN230002 |
|
10/04/2023 |
|
Masimo SafetyNet
|
Masimo Corporation |
DEN200011 |
|
03/31/2023 |
|
ORi
|
Masimo Corporation |
DEN200076 |
|
10/12/2023 |
|
Bonebridge
|
Med-El Elektromedizinische Geraete GmbH |
DEN170009 |
|
07/20/2018 |
|
PMD-200
|
Medasense Biometrics , Ltd. |
DEN210022 |
|
02/17/2023 |
|
iTind System
|
Medi-Tate , Ltd. |
DEN190020 |
|
02/25/2020 |
|
Comfort Marker 2.0.
|
Medical Precision BV |
DEN200041 |
|
12/10/2021 |
|
Medline ART Skin Harvesting System
|
Medline Industries, Inc. |
DEN210049 |
|
03/27/2024 |
|
SureTune4 Software
|
Medtronic Neuromodulation |
DEN210003 |
|
08/23/2021 |
|
Medtronic DUET External Drainage and Mon
|
Medtronic Neurosurgery |
DEN120017 |
|
08/22/2014 |
|
Hominis Surgical System
|
Memic Innovative Surgery , Ltd. |
DEN190022 |
|
02/26/2021 |
|
MSK-IMPACT (Integrated Mutation Profilin
|
Memorial Sloan-Kettering Cancer Center |
DEN170058 |
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11/15/2017 |
|
Alethia CMV DNA Amplification Assay, Ale
|
Meridian Bioscience, Inc. |
DEN180040 |
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11/30/2018 |
|
BEAR (Bridge-Enhanced ACL Repair) Implan
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Miach Orthopaedics, Inc. |
DEN200035 |
|
12/16/2020 |
|
Permaseal
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Micro Interventional Devices,Inc. |
DEN150029 |
|
07/27/2016 |
|
QMS Plazomicin Immunoassay
|
Microgenics Corporation |
DEN180030 |
|
11/19/2018 |
|
Miris Human Milk Analyzer
|
Miris AB |
DEN180007 |
|
12/21/2018 |
|
Symani Surgical System
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Mmi North America, Inc. |
DEN230032 |
|
04/05/2024 |
|
MOERAE SURGICAL MARKING PEN
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Moerae Matrix, Inc. |
DEN130004 |
|
12/18/2014 |
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MolecuLight i:X
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Moleculight, Inc. |
DEN180008 |
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07/31/2018 |
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MISHA Knee System
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Moximed, Inc. |
DEN220033 |
|
04/10/2023 |
|
MuReva OM™
|
Mureva Phototherapy, Inc. |
DEN240077 |
|
11/26/2025 |
|
Myocene
|
Myocene |
DEN230051 |
|
01/17/2025 |
|
CORIS System
|
Nanosonics Limited |
DEN240018 |
|
03/19/2025 |
|
BioXmark
|
Nanovi A/S |
DEN220017 |
|
12/23/2022 |
|
Natural Cycles
|
Natural Cycles Nordic AB |
DEN170052 |
|
08/10/2018 |
|
Neurolutions Upper Extremity Rehabilitat
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Neurolutions, Inc. |
DEN200046 |
|
04/23/2021 |
|
Quell-FM
|
Neurometrix, Inc. |
DEN210046 |
|
05/18/2022 |
|
Lenire Tinnitus Treatment Device
|
Neuromod Devices Limited |
DEN210033 |
|
03/06/2023 |
|
Monarch eTNS System
|
Neurosigma, Inc. |
DEN180041 |
|
04/19/2019 |
|
Modius Lean
|
Neurovalens Limited |
DEN240076 |
|
10/17/2025 |
|
NightWare Kit, Apple iPhone, Apple Watch
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Nightware, Inc. |
DEN200033 |
|
11/06/2020 |
|
NTX100 Tonic Motor Activation (NTX100 To
|
Noctrix Health, Inc. |
DEN220059 |
|
04/17/2023 |
|
Notal Vision Home Optical Coherence Tomo
|
Notal Vision, Inc. |
DEN230043 |
|
05/15/2024 |
|
First To Know Syphilis Test
|
Nowdiagnostics |
DEN230090 |
|
08/16/2024 |
|
Oculeve Intranasal Tear Neurostimulator
|
Oculeve, Inc. |
DEN160030 |
|
04/24/2017 |
|
EyeBOX
|
Oculogica, Inc. |
DEN170091 |
|
12/28/2018 |
|
iTEAR Neurostimulator
|
Olympic Ophthalmics, Inc. |
DEN190026 |
|
05/01/2020 |
|
Omron Blood Pressure Monitor with Atrial
|
Omron Healthcare, Inc. |
DEN230076 |
|
10/08/2024 |
|
SeCore CDx HLA Sequencing System
|
One Lambda, Inc. |
BR220737 |
|
11/28/2022 |
|
ELEOSx™ Limb Salvage System
|
Onkos Surgical |
DEN210058 |
|
04/05/2024 |
|
ARC-EX System
|
Onward Medical, Inc. |
DEN240014 |
|
12/19/2024 |
|
OraQuick Ebola Rapid Antigen Test
|
Orasure Technologies, Inc. |
DEN190025 |
|
10/10/2019 |
|
VITROS Immunodiagnostic Products Anti-SA
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Ortho-Clinical Diagnostics, Inc. |
DEN210038 |
|
05/05/2023 |
|
VITROS Immunodiagnostic Products Anti-SA
|
Ortho-Clinical Diagnostics, Inc. |
DEN210040 |
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05/05/2023 |
|
InSpace Subacromial Tissue Spacer System
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Ortho-Space , Ltd. |
DEN200039 |
|
07/12/2021 |
|
Orthobond Mariner Pedicle Screw System
|
Orthobond Coporation |
DEN220015 |
|
04/05/2024 |
|
remOVE System
|
Ovesco Endoscopy AG |
DEN160014 |
|
12/22/2017 |
|
Dream Sock
|
Owlet Babycare, Inc. |
DEN220091 |
|
11/08/2023 |
|
Oxehealth Vital Signs
|
Oxehealth Limited |
DEN200019 |
|
03/26/2021 |
|
Paige Prostate
|
Paige.Ai |
DEN200080 |
|
09/21/2021 |
|
PainChek (PainChek Adult)
|
Painchek Limited (Ltd.) |
DEN240073 |
|
10/06/2025 |
|
reSet
|
Pear Therapeutics, Inc. |
DEN160018 |
|
09/14/2017 |
|
ECLIPSE SYSTEM
|
Pelvalon |
DEN140020 |
|
02/12/2015 |
|
GSP Neonatal Creatine Kinase - MM kit
|
Perkinelmer, Inc. |
DEN180056 |
|
12/12/2019 |
|
Eonis SCID-SMA Kit
|
Perkinelmer, Inc. |
DEN200044 |
|
11/09/2022 |
|
PGDx elio plasma focus Dx
|
Personal Genome Diagnostics, Inc. |
DEN230046 |
|
08/01/2024 |
|
AMStent® Tracheobronchial Covered Stent
|
Peytant Solutions, Inc. |
DEN230087 |
|
10/16/2024 |
|
Phagenyx System
|
Phagenesis Limited |
DEN220025 |
|
09/16/2022 |
|
Philips IntelliSite Pathology Solution
|
Philips Medical Systems Nederland B.V. |
DEN160056 |
|
04/12/2017 |
|
ShortCut
|
Pi-Cardia, Ltd. |
DEN240017 |
|
09/27/2024 |
|
Prapela SVS hospital bassinet pad (model
|
Prapela, Inc. |
DEN240031 |
|
04/04/2025 |
|
Sepsis ImmunoScore
|
Prenosis, Inc. |
DEN230036 |
|
04/02/2024 |
|
CleanCisionTM Wound Retraction and Prote
|
Prescient Surgical |
DEN150038 |
|
12/16/2016 |
|
POMC/PCSK1/LEPR CDx Panel
|
Preventiongenetics, LLC |
DEN200059 |
|
01/21/2022 |
|
AQUABEAM System
|
Procept Biorobotics, Corporation |
DEN170024 |
|
12/21/2017 |
|
Procise IFX
|
Procisedx, Inc. |
DEN210056 |
|
09/29/2023 |
|
Procise ADL
|
Procisedx, Inc. |
DEN220023 |
|
09/29/2023 |
|
Pulsenmore ES
|
Pulsenmore, Ltd. |
DEN240074 |
|
10/31/2025 |
|
Q-Collar
|
Q30 Sports Science, LLC |
DEN200017 |
|
02/26/2021 |
|
ipsogen JAK2 RGQ PCR Kit
|
Qiagen, Inc. |
DEN160028 |
|
03/27/2017 |
|
Delphi-MD System
|
Quantalx Neuroscience, Ltd. |
DEN250002 |
|
08/20/2025 |
|
QuantX
|
Quantitative Insights, Inc. |
DEN170022 |
|
07/19/2017 |
|
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS
|
Quidel Corporation |
DEN220039 |
|
03/08/2023 |
|
ConcizuTrace™ ELISA
|
Randox Laboratories, Ltd. |
DEN240035 |
|
05/22/2025 |
|
BraidE Embolization Assist Device
|
Rapid Medical , Ltd. |
DEN230064 |
|
02/21/2024 |
|
Comaneci, Comaneci Petit, Comaneci 17
|
Rapid-Medical , Ltd. |
DEN170064 |
|
04/24/2019 |
|
PEDIATRIC VISION SCANNER
|
Rebiscan, Inc. |
DEN130051 |
|
06/08/2016 |
|
OcuCool
|
Recensmedical, Inc. |
DEN230011 |
|
09/30/2024 |
|
RefleXion Medical Radiotherapy System (R
|
Reflexion Medical, Inc. |
DEN220014 |
|
02/01/2023 |
|
Spur Peripheral Retrievable Stent System
|
Reflow Medical, Inc. |
DEN240048 |
|
05/29/2025 |
|
KidneyIntelX.dkd
|
Renalytix Ai, Inc. |
DEN200052 |
|
06/29/2023 |
|
Elecsys AMH, AMH CalSet, PreciControl AM
|
Roche Diagnostics |
DEN150057 |
|
12/19/2016 |
|
cobas vivoDx MRSA
|
Roche Molecular Systems, Inc. |
DEN190016 |
|
12/05/2019 |
|
cobas EBV, cobas EBV/BKV Control Kit, co
|
Roche Molecular Systems, Inc. |
DEN200015 |
|
07/30/2020 |
|
AccuMeasure System
|
Rqmis, Inc. |
DEN210032 |
|
07/26/2022 |
|
Ruthless Spine RJB
|
Ruthless, LLC Dba Ruthless Spine |
DEN230012 |
|
07/14/2023 |
|
esolution
|
S4 Medical Corp. |
DEN230006 |
|
09/06/2023 |
|
FETAL PILLOW
|
Safe Obstetric Systems, Ltd. |
DEN150053 |
|
07/27/2017 |
|
MyCare Psychiatry Clozapine Assay Kit
|
Saladax Biomedical, Inc. |
DEN190028 |
|
04/16/2020 |
|
Sleep Apnea Feature
|
Samsung Electronics Co., Ltd. |
DEN230041 |
|
02/06/2024 |
|
dermaPACE System
|
Sanuwave, Inc. |
DEN160037 |
|
12/28/2017 |
|
Early Bird Bleed Monitoring System
|
Saranas, Inc. |
DEN180021 |
|
03/01/2019 |
|
Sensor Monitored Alimentary Restriction
|
Scientific Intake |
DEN150033 |
|
09/26/2016 |
|
ThermoNeuroModulation Device, TNM Device
|
Scion Neurostim, LLC |
DEN170023 |
|
03/26/2018 |
|
X100 with Full Field Bone Marrow Aspirat
|
Scopio Labs , Ltd. |
DEN230034 |
|
03/22/2024 |
|
Eversense AP CGM System
|
Senseonics, Incorporated |
DEN230052 |
|
04/29/2024 |
|
SENSIMED TRIGGERFISH
|
Sensimed AG |
DEN140017 |
|
03/04/2016 |
|
INNOVANCE VWF Ac
|
Siemens Healthcare Diagnostics Products |
DEN200067 |
|
09/29/2022 |
|
ADVIA Centaur Enhanced Liver Fibrosis (E
|
Siemens Healthcare Diagnostics, Inc. |
DEN190056 |
|
08/20/2021 |
|
eXciteOSA with remote and eXciteOSA with
|
Signifier Medical Technologies |
DEN200018 |
|
02/05/2021 |
|
BioHealx Anal Fistula Device
|
Signum Surgical Limited |
DEN240007 |
|
07/01/2024 |
|
SafeBreak Vascular
|
Site Saver, Inc. D/B/A Lineus Medical |
DEN190043 |
|
05/27/2021 |
|
SoClean 3+ Bacterial Reduction Device
|
Soclean, Inc. |
DEN210037 |
|
08/12/2024 |
|
cNEP Airway
|
Sommetrics |
DEN140024 |
|
12/23/2015 |
|
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH
|
Somna Therapeutics, LLC |
DEN130046 |
|
03/06/2015 |
|
Sonablate 450
|
Sonacare Medical, LLC |
DEN150011 |
|
10/09/2015 |
|
Stone Clear (SC-LP9-01)
|
Sonomotion, Inc. |
DEN230082 |
|
10/30/2024 |
|
Sonu
|
Sound Health Systems, Inc. |
DEN230045 |
|
12/04/2023 |
|
CavaClear Laser Sheath
|
Spectranetics, Inc. |
DEN210024 |
|
12/21/2021 |
|
Spineology Interbody Fusion System
|
Spineology, Inc. |
DEN200010 |
|
09/18/2020 |
|
EasySep™ Human Bone Marrow CD138 Positiv
|
Stemcell Technologies Canada, Inc. |
DEN220090 |
|
11/06/2023 |
|
VERIFY RESI-TEST SLIDE-THRU Cleaning Pro
|
Steris |
DEN230085 |
|
11/12/2024 |
|
Hem-Avert Perianal Stabilizer
|
Stetrix, Inc. |
DEN160005 |
|
12/19/2016 |
|
Cell-Free DNA BCT
|
Streck, Inc. |
DEN200001 |
|
08/07/2020 |
|
Sunrise Sleep Disorder Diagnostic Aid
|
Sunrise |
DEN210015 |
|
01/07/2022 |
|
Stanza
|
Swing Therapeutics, Inc. |
DEN220083 |
|
05/09/2023 |
|
T2CANDIDA AND T2DX INSTRUMENT
|
T2biosystems, Inc. |
DEN140019 |
|
09/22/2014 |
|
t:slim X2 insulin pump with interoperabl
|
Tandem Diabetes Care, Inc. |
DEN180058 |
|
02/14/2019 |
|
Control-IQ Technology
|
Tandem Diabetes Care, Inc. |
DEN190034 |
|
12/13/2019 |
|
Tangible Boost
|
Tangible Science, Inc. |
DEN200002 |
|
09/24/2020 |
|
Teal Wand
|
Teal Health, Inc. |
DEN240045 |
|
05/09/2025 |
|
Technozym ADAMTS13 Activity
|
Technoclone Herstellung Von Diagnostika |
DEN230024 |
|
02/28/2024 |
|
BioTraceIO Lite
|
Techsomed Medical Technologies , Ltd. |
DEN230020 |
|
12/22/2023 |
|
ZANZA-CLICK
|
Tecnimed S.R.L. |
DEN130019 |
|
11/07/2014 |
|
Terragene Bionova Photon Biological Indi
|
Terragene S.A. |
DEN220042 |
|
07/12/2024 |
|
Nerivio Migra
|
Theranica Bioelectronics , Ltd. |
DEN180059 |
|
05/20/2019 |
|
ClearMate
|
Thornhill Research, Inc. |
DEN170044 |
|
03/14/2019 |
|
Enlight 1810
|
Timpel, Inc. |
DEN170072 |
|
12/20/2018 |
|
COAPTIUM Connect with TISSIUM LIGHT
|
Tissium SA |
DEN240066 |
|
06/17/2025 |
|
ClearUP Sinus Relief
|
Tivic Health Systems, Inc. |
DEN200006 |
|
03/05/2021 |
|
Tornier Pyrocarbon Humeral Head
|
Tornier S.A.S. |
DEN220012 |
|
12/16/2022 |
|
Tristel Duo ULT
|
Tristel Solutions Limited |
DEN220041 |
|
06/02/2023 |
|
allay Nerve Cap
|
Tulavi Therapeutics |
DEN230061 |
|
07/16/2024 |
|
everlinQ endoAVF System
|
Tva Medical, Inc. |
DEN160006 |
|
06/22/2018 |
|
Precision Flow® HVNI
|
Vapotherm, Inc. |
DEN170001 |
|
04/10/2018 |
|
Sentosa SQ HIV Genotyping Assay
|
Vela Diagnostics USA Inc |
BR190330 |
|
11/05/2019 |
|
VENTANA anti-MLH-1(M1) Mouse Monoclonal
|
Ventana Medical Systems |
DEN170030 |
|
10/27/2017 |
|
CINtec Histology (50 tests), CINtec Hist
|
Ventana Medical Systems, Inc. |
DEN160019 |
|
03/04/2017 |
|
VENTANA Kappa and Lambda Dual ISH mRNA P
|
Ventana Medical Systems, Inc. |
DEN240025 |
|
12/05/2024 |
|
INFLOW INTRAURETHRAL VALVE-PUMP
|
Vesiflo, Inc. |
DEN130044 |
|
10/14/2014 |
|
Vibrant System
|
Vibrant, Ltd. |
DEN210052 |
|
08/26/2022 |
|
vPatch
|
Virility Medical |
DEN210012 |
|
11/23/2021 |
|
MIRA Surgical System
|
Virtual Incision |
DEN230025 |
|
02/23/2024 |
|
Visby Medical Women's Sexual Health Test
|
Visby Medical, Inc. |
DEN240020 |
|
03/28/2025 |
|
Viz HCM
|
Viz. Ai, Inc. |
DEN230003 |
|
08/03/2023 |
|
ContaCT
|
Viz.Al, Inc. |
DEN170073 |
|
02/13/2018 |
|
PERKINELMER ENLITE NEONATAL TREC TEST SY
|
Wallac OY |
DEN140010 |
|
12/15/2014 |
|
BRAINPORT V100 DEVICE
|
Wicab, Inc. |
DEN130039 |
|
06/18/2015 |
|
Hemospray Endoscopic Hemostat
|
Wilson-Cook Medical, Inc. |
DEN170015 |
|
05/07/2018 |
|
OGmend Implant System
|
Woven Orthopedic Technologies, LLC |
DEN180065 |
|
05/01/2020 |
|
LightStrike+ (MXSUV1-SL and MXSUV1-FT)
|
Xenex Disinfection Services, Inc. |
DEN230007 |
|
09/01/2023 |
|
D2 Dressing
|
Z-Medica, LLC |
DEN160012 |
|
06/30/2017 |
|
MATRx plus
|
Zephyr Sleep Technologies |
DEN170090 |
|
08/23/2018 |
|
Zuno Smart Sterilization Container
|
Zuno Medical, Inc. |
DEN210004 |
|
06/17/2022 |
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