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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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1 to 437 of 437 results
Decision Date To: 08/18/2023
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Stone Clear (SC-LP9-01) SonoMotion, Inc. DEN230082 10/30/2024
Dexter L6 System Distalmotion, SA DEN230084 10/25/2024
AMStent® Tracheobronchial Covered Stent Peytant Solutions, Inc. DEN230087 10/16/2024
Versius Surgical System CMR Surgical Limited DEN230078 10/11/2024
Omron Blood Pressure Monitor with Atrial Omron Healthcare, Inc. DEN230076 10/08/2024
Healgen Rapid Check COVID-19/Flu A&B Ant Healgen DEN240029 10/07/2024
OcuCool RecensMedical, Inc. DEN230011 09/30/2024
ShortCut Pi-Cardia Ltd. DEN240017 09/27/2024
Hearing Aid Feature (HAF) Apple Inc. DEN230081 09/12/2024
Chronos® Germitec DEN230067 08/28/2024
First To Know Syphilis Test NOWDiagnostics DEN230090 08/16/2024
SoClean 3+ Bacterial Reduction Device SoClean, Inc. DEN210037 08/12/2024
PGDx elio plasma focus Dx Personal Genome Diagnostics, Inc. DEN230046 08/01/2024
allay Nerve Cap Tulavi Therapeutics DEN230061 07/16/2024
Simplexa C. auris Direct, Simplexa C. au DiaSorin Molecular LLC DEN230092 07/15/2024
Terragene Bionova Photon Biological Indi Terragene SA DEN220042 07/12/2024
MagDI System GT Metabolic Solutions, Inc. DEN240013 07/02/2024
BioHealx Anal Fistula Device Signum Surgical Limited DEN240007 07/01/2024
FSYX™ Ocular Pressure Adjusting Pump (FS Balance Ophthalmics, Inc. DEN230055 06/27/2024
Xpert HCV; GeneXpert Xpress System Cepheid DEN240016 06/27/2024
Mi-CHORD System LSI SOLUTIONS, Inc. DEN230069 06/11/2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M Company DEN230068 05/21/2024
DentalMonitoring Dental Monitoring SAS DEN230035 05/17/2024
Notal Vision Home Optical Coherence Tomo Notal Vision Inc DEN230043 05/15/2024
Eversense AP CGM System Senseonics, Incorporated DEN230052 04/29/2024
Rho 16 Bit Inc DEN230023 04/09/2024
Symani Surgical System MMI North America, Inc. DEN230032 04/05/2024
ELEOSx™ Limb Salvage System Onkos Surgical DEN210058 04/05/2024
Orthobond Mariner Pedicle Screw System Orthobond Coporation DEN220015 04/05/2024
Sepsis ImmunoScore Prenosis, Inc. DEN230036 04/02/2024
Medline ART Skin Harvesting System Medline Industries, Inc DEN210049 03/27/2024
X100 with Full Field Bone Marrow Aspirat Scopio Labs Ltd. DEN230034 03/22/2024
Technozym ADAMTS13 Activity Technoclone Herstellung von Diagnostika DEN230024 02/28/2024
MIRA Surgical System Virtual Incision DEN230025 02/23/2024
BraidE Embolization Assist Device Rapid Medical Ltd. DEN230064 02/21/2024
Sleep Apnea Feature Samsung Electronics Co., Ltd DEN230041 02/06/2024
“Genius™ Digital Diagnostics System with Hologic Inc. DEN210035 01/31/2024
VerTouch Spinal Imaging Device IntuiTap Medical, Inc. DEN220009 01/19/2024
Osteoboost Belt Bone Health Technologies, Inc DEN230015 01/12/2024
DermaSensor DermaSensor Inc. DEN230008 01/12/2024
Fibresolve Imvaria, Inc DEN220040 01/12/2024
BrainSee Darmiyan, Inc. DEN220066 01/11/2024
BioTraceIO Lite TechsoMed Medical Technologies Ltd. DEN230020 12/22/2023
Body Temperature Software (BTS) Fitbit LLC DEN230050 12/15/2023
NaviCam ProScan Ankon Technologies Co., Ltd DEN230027 12/12/2023
Sonu Sound Health Systems, Inc. DEN230045 12/04/2023
Simple 2 Test LetsGetChecked Inc. (formerly PrivaPath DEN200070 11/15/2023
Dream Sock Owlet Baby Care, Inc. DEN220091 11/08/2023
EasySep™ Human Bone Marrow CD138 Positiv STEMCELL Technologies Canada Inc. DEN220090 11/06/2023
ORi Masimo Corporation DEN200076 10/12/2023
Edison System HistoSonics, Inc. DEN220087 10/06/2023
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
Invitae Common Hereditary Cancers Panel Invitae Corporation DEN210011 09/29/2023
Procise IFX ProciseDx Inc. DEN210056 09/29/2023
Procise ADL ProciseDx Inc. DEN220023 09/29/2023
VasQ Laminate Medical Technologies Ltd. DEN220026 09/26/2023
Hemanext ONE Hemanext, Inc. BR220665 09/15/2023
ensoETM Advanced Cooling Therapy, Inc. d/b/a Att DEN230021 09/13/2023
esolution S4 Medical Corp DEN230006 09/06/2023
LightStrike+ (MXSUV1-SL and MXSUV1-FT) Xenex Disinfection Services, Inc. DEN230007 09/01/2023
BrachyGel Vaginal Hydrogel Packing Syste BrachyFoam, Inc. d/b/a Advaray DEN220052 08/22/2023
AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
Viz HCM Viz.ai, Inc. DEN230003 08/03/2023
Galen ES Cooperative Surgical Assistant Galen Robotics DEN220047 07/19/2023
Ruthless Spine RJB Ruthless, LLC dba Ruthless Spine DEN230012 07/14/2023
BT-001 Better Therapeutics DEN220058 07/07/2023
KidneyIntelX.dkd Renalytix AI, Inc. DEN200052 06/29/2023
Neoasis Invictus Medical, Inc. DEN220048 06/16/2023
Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
Cue COVID-19 Molecular Test Cue Health Inc. DEN220028 06/06/2023
Tristel Duo ULT Tristel Solutions Limited DEN220041 06/02/2023
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy BRAHMS GmbH, Part of Thermo Fisher Scien DEN220027 05/18/2023
Stanza Swing Therapeutics, Inc. DEN220083 05/09/2023
VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210038 05/05/2023
VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210040 05/05/2023
Breast Implant Removal Device (BIRD) Gaylord Solutions, LLC DEN220082 04/20/2023
NTX100 Tonic Motor Activation (NTX100 To Noctrix Health, Inc. DEN220059 04/17/2023
MISHA Knee System Moximed, Inc. DEN220033 04/10/2023
The N-SWEAT Patch Candesant Biomedical, Inc. DEN210055 04/07/2023
Masimo SafetyNet Masimo Corporation DEN200011 03/31/2023
SNOO Smart Sleeper Happiest Baby, Inc. DEN210039 03/30/2023
RemeOs™ Screw LAG Solid Bioretec Ltd. DEN220030 03/29/2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Quidel Corporation DEN220039 03/08/2023
Lenire Tinnitus Treatment Device Neuromod Devices Limited DEN210033 03/06/2023
Caption Interpretation Automated Ejectio Caption Health, Inc DEN220063 02/24/2023
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
Active Anthrax DetectTM Plus Rapid Test InBios International, Inc. DEN220044 02/03/2023
RefleXion Medical Radiotherapy System (R RefleXion Medical Inc DEN220014 02/01/2023
BioXmark Nanovi A/S DEN220017 12/23/2022
Tornier Pyrocarbon Humeral Head Tornier SAS DEN220012 12/16/2022
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
Eonis SCID-SMA Kit PerkinElmer Inc. DEN200044 11/09/2022
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products DEN200067 09/29/2022
Phagenyx System Phagenesis Limited DEN220025 09/16/2022
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
Zuno Smart Sterilization Container Zuno Medical, Inc. DEN210004 06/17/2022
ProdiGI Covidien LLC DEN220006 06/13/2022
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
Quell-FM NeuroMetrix, Inc. DEN210046 05/18/2022
CERAMENT G BoneSupport AB DEN210044 05/17/2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics, Inc. DEN200072 05/04/2022
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066 04/29/2022
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
ONE Male Condom Global Protection Corp. DEN210034 02/23/2022
POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059 01/21/2022
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
CavaClear Laser Sheath Spectranetics, Inc. DEN210024 12/21/2021
Comfort Marker 2.0. Medical Precision B.V. DEN200041 12/10/2021
Klox Biophotonic LumiHeal System Klox Technlogies Inc. DEN200005 12/03/2021
vPatch Virility Medical DEN210012 11/23/2021
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
Hemolung Respiratory Assist System ALung Technologies, Inc. DEN210006 11/13/2021
OMNIgene GUT Dx DNA Genotek Inc. DEN200040 11/03/2021
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
iotaSOFT Insertion System - Drive Unit, IotaMotion, Inc. DEN190055 10/01/2021
Paige Prostate Paige.AI DEN200080 09/21/2021
FEops HEARTguide FEops NV DEN200030 09/08/2021
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
SureTune4 Software Medtronic Neuromodulation DEN210003 08/23/2021
ADVIA Centaur Enhanced Liver Fibrosis (E Siemens Healthcare Diagnostics Inc. DEN190056 08/20/2021
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
InSpace Subacromial Tissue Spacer System Ortho-Space Ltd. DEN200039 07/12/2021
Cognoa ASD Diagnosis Aid Cognoa, Inc. DEN200069 06/02/2021
SafeBreak Vascular Site Saver, Inc. d/b/a Lineus Medical DEN190043 05/27/2021
Neurolutions Upper Extremity Rehabilitat Neurolutions, Inc. DEN200046 04/23/2021
GI Genius Cosmo Artificial Intelligence - AI, LTD DEN200055 04/09/2021
Gili Pro BioSensor (also known as “Gili ContinUse Biometrics Ltd. DEN200038 04/01/2021
Portable Neuromodulation Stimulator (PoN Helius Medical, Inc. DEN200050 03/26/2021
Oxehealth Vital Signs Oxehealth Limited DEN200019 03/26/2021
BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC DEN200031 03/17/2021
ClearUP Sinus Relief Tivic Health Systems Inc. DEN200006 03/05/2021
Analytic for Hemodynamic Instability (AH Fifth Eye Inc. DEN200022 03/01/2021
Hominis Surgical System Memic Innovative Surgery Ltd. DEN190022 02/26/2021
Q-Collar Q30 Sports Science, LLC DEN200017 02/26/2021
Lumenis Stellar M22 Lumenis Ltd. DEN200028 02/23/2021
eXciteOSA with remote and eXciteOSA with Signifier Medical Technologies DEN200018 02/05/2021
Helix Laboratory Platform Helix OpCo, LLC DEN190035 12/23/2020
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
BEAR (Bridge-Enhanced ACL Repair) Implan Miach Orthopaedics, Inc. DEN200035 12/16/2020
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
CADScor System Acarix A/S DEN190047 11/24/2020
FilmArray Global Fever Panel BioFire Defense, LLC DEN200043 11/20/2020
Acumen Assisted Fluid Management (AFM) S Edwards Lifesciences DEN190029 11/13/2020
NightWare Kit, Apple iPhone, Apple Watch NightWare, Inc DEN200033 11/06/2020
Tangible Boost Tangible Science, Inc. DEN200002 09/24/2020
Spineology Interbody Fusion System Spineology, Inc. DEN200010 09/18/2020
ToothWave™ Home Skinovations Ltd. DEN190039 09/17/2020
HemosIL Liquid Anti-Xa Instrumentation Laboratory Co. DEN190032 09/17/2020
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
Cell-Free DNA BCT Streck, Inc. DEN200001 08/07/2020
cobas EBV, cobas EBV/BKV Control Kit, co Roche Molecular Systems, Inc. DEN200015 07/30/2020
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
NP Screen Advance Sentry Corporation DEN190031 05/11/2020
iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
OGmend Implant System Woven Orthopedic Technologies, LLC DEN180065 05/01/2020
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
MyCare Psychiatry Clozapine Assay Kit Saladax Biomedical Inc DEN190028 04/16/2020
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
AmplideX Fragile X Dx & Carrier Screen K Asuragen, Inc. DEN190023 02/21/2020
Surfacer Inside-Out Access Catheter Syst Bluegrass Vascular Technologies, Inc. DEN190038 02/10/2020
Caption Guidance Bay Labs, Inc. DEN190040 02/07/2020
Mucosal Integrity Conductivity (MI) Test Diversatek Healthcare Inc. DEN180067 12/23/2019
Control-IQ Technology Tandem Diabetes Care, Inc. DEN190034 12/13/2019
GSP Neonatal Creatine Kinase - MM kit PerkinElmer Inc. DEN180056 12/12/2019
cobas vivoDx MRSA Roche Molecular Systems, Inc. DEN190016 12/05/2019
WOUNDCHEK Bacterial Status Alere Scarborough, Inc. DEN180014 12/02/2019
EchoTip Insight Portosystemic Pressure G Cook Ireland Ltd. DEN180062 11/20/2019
Sentosa SQ HIV Genotyping Assay Vela Diagnostics USA Inc BR190330 11/05/2019
OraQuick Ebola Rapid Antigen Test OraSure Technologies, Inc. DEN190025 10/10/2019
IB-Stim Innovative Health Solutions (IHS), Inc. DEN180057 06/07/2019
Synovasure Alpha Defensin Lateral Flow T CD Diagnostics Inc. DEN180032 05/23/2019
ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. DEN180069 05/23/2019
Nerivio Migra Theranica Bioelectronics ltd DEN180059 05/20/2019
Comaneci, Comaneci Petit, Comaneci 17 Rapid-Medical Ltd. DEN170064 04/24/2019
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
Monarch eTNS System NeuroSigma, Inc DEN180041 04/19/2019
Plenity Gelesis, Inc. DEN180060 04/12/2019
LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
Leica FL400 Leica Microsystems (Schweiz) AG DEN180024 03/28/2019
ClearMate Thornhill Research, Inc. DEN170044 03/14/2019
Quantra Hemostasis Analyzer, QPlus Cartr HemoSonics, LLC DEN180017 03/12/2019
Early Bird Bleed Monitoring System Saranas, Inc. DEN180021 03/01/2019
t:slim X2 insulin pump with interoperabl Tandem Diabetes Care, Inc. DEN180058 02/14/2019
Aptima Mycoplasma genitalium Assay Hologic, Inc. DEN180047 01/23/2019
EyeBOX Oculogica, Inc. DEN170091 12/28/2018
MLL (KMT2A) Breakapart FISH Probe Kit; A Cytocell Ltd DEN170070 12/21/2018
Miris Human Milk Analyzer Miris AB DEN180007 12/21/2018
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
Enlight 1810 Timpel Inc. DEN170072 12/20/2018
Retrograde Intubation Set Cook Incorporated DEN170055 12/12/2018
Alethia CMV DNA Amplification Assay, Ale Meridian Bioscience, Inc. DEN180040 11/30/2018
QMS Plazomicin Immunoassay Microgenics Corporation DEN180030 11/19/2018
Innovo Bio-Medical Research Ltd. DEN170049 11/06/2018
Parathyroid Detection (Model PTeye) Syst AiBiomed, Corp. DEN170056 11/02/2018
Fluobeam 800 Clinic Imaging Device used Fluoptics DEN170092 11/02/2018
23andMe Personal Genome Service (PGS) Ph 23andMe, Inc. DEN180028 10/31/2018
picoAMH ELISA Ansh Labs LLC DEN180004 10/24/2018
Bose Hearing Aid Bose Corporation DEN180026 10/05/2018
Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation DEN170080 09/28/2018
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR CENTERS FOR DISEASE CONTROL AND PREVENTI DEN070001 09/21/2018
Irregular Rhythm Notification Feature Apple Inc DEN180042 09/11/2018
ECG App Apple Inc DEN180044 09/11/2018
MATRx plus Zephyr Sleep Technologies DEN170090 08/23/2018
Brainsway Deep Transcranial Magnetic Sti Brainways Ltd. DEN170078 08/17/2018
Natural Cycles Natural Cycles Nordic AB DEN170052 08/10/2018
MolecuLight i:X MolecuLight Inc. DEN180008 07/31/2018
Bonebridge MED-EL Elektromedizinische Geraete GmbH DEN170009 07/20/2018
Ellipsys Vascular Access System Avenu Medical, Inc DEN170004 06/22/2018
everlinQ endoAVF System TVA Medical, Inc. DEN160006 06/22/2018
DreaMed Advisor Pro DreaMed Diabetes, Ltd. DEN170043 06/12/2018
Curve Positive Airway Pressure System FRESCA Medical DEN170089 06/05/2018
OsteoDetect Imagen Technologies, Inc. DEN180005 05/24/2018
TrueTear Intranasal Tear Neurostimulator Allergan DEN170086 05/17/2018
Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc DEN170015 05/07/2018
Cala ONE Cala Health, Inc. DEN170028 04/26/2018
MALDI Biotyper CA System Bruker Daltonik GmbH DEN170081 04/20/2018
LZI Carisoprodol Metabolite (Meprobamate Lin-Zhi International, Inc. DEN170010 04/20/2018
IDx-DR IDx, LLC DEN180001 04/11/2018
Precision Flow® HVNI VAPOTHERM, INC. DEN170001 04/10/2018
Curetis Unyvero LRT Application Curetis GmbH DEN170047 04/03/2018
Dexcom G6 Continuous Glucose Monitoring Dexcom, Inc. DEN170088 03/27/2018
ThermoNeuroModulation Device, TNM Device Scion NeuroStim, LLC DEN170023 03/26/2018
PrimeStore MTM Longhorn Vaccines and Diagnostics LLC DEN170029 03/19/2018
Acumen Hypotension Prediction Index (HPI Edwards Lifesciences LLC DEN160044 03/16/2018
23andMe PGS Genetic Health Risk Report f 23andMe, Inc. DEN170046 03/06/2018
SkinPen Precision System BELLUS MEDICAL, LLC. DEN160029 03/01/2018
Banyan BTI Banyan Biomarkers, Inc. DEN170045 02/14/2018
ContaCT Viz.Al, Inc. DEN170073 02/13/2018
dermaPACE System SANUWAVE, INC. DEN160037 12/28/2017
remOVE System OVESCO ENDOSCOPY AG DEN160014 12/22/2017
AQUABEAM System PROCEPT BioRobotics Corporation DEN170024 12/21/2017
ContainOR Advanced Surgical Concepts Ltd. DEN170075 12/19/2017
IlluminOss Bone Stabilization System IllminOss Medical, Inc. DEN160062 12/19/2017
GeneSTAT.MDx Coccidioides Assay DxNA, LLC DEN170041 11/29/2017
FilmArray Respiratory Panel 2 plus (RP2p BioFire Diagnostics, LLC DEN170017 11/24/2017
NSS-2 System Innovative Health Solutions (IHS), Inc. DEN170018 11/15/2017
MSK-IMPACT (Integrated Mutation Profilin Memorial Sloan-Kettering Cancer Center DEN170058 11/15/2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Ventana Medical Systems DEN170030 10/27/2017
reSet PEAR THERAPEUTICS, INC. DEN160018 09/14/2017
ID-FISH Plasmodium Genus Test Kit, ID-FI ID-FISH TECHNOLOGY, INC DEN160025 08/18/2017
FETAL PILLOW SAFE OBSTETRIC SYSTEMS LTD DEN150053 07/27/2017
QuantX Quantitative Insights, Inc DEN170022 07/19/2017
D2 Dressing Z-MEDICA, LLC DEN160012 06/30/2017
ClearLLab T1, ClearLLab T2, ClearLLab B1 Beckman Coulter DEN160047 06/29/2017
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
Sentinel Cerebral Protection System Claret Medical, Inc. DEN160043 06/01/2017
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC DEN160033 05/05/2017
Oculeve Intranasal Tear Neurostimulator OCULEVE, INC. DEN160030 04/24/2017
gammaCore Non-invasive Vagus Nerve Stimu electroCore, LLC DEN150048 04/14/2017
Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. DEN160056 04/12/2017
23andMe Personal Genome Service (PGS) Ge 23andMe, Inc. DEN160026 04/06/2017
ipsogen JAK2 RGQ PCR Kit QIAGEN INC DEN160028 03/27/2017
CINtec Histology (50 tests), CINtec Hist VENTANA MEDICAL SYSTEMS, INC DEN160019 03/04/2017
Accelerate Pheno system, Accelerate Phen ACCELERATE DIAGNOTICS DEN160032 02/23/2017
Companion LGCH, INC DEN140033 02/16/2017
FilmArray NGDS Warrior Panel BioFire Defense, LLC DEN160048 02/14/2017
Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTI DEN160016 02/06/2017
SEEKER System Baebies, Inc. DEN150035 02/03/2017
AeroForm Tissue Expander System AIRXPANDERS, INC DEN150055 12/21/2016
CipherOx CRI Tablet Flashback Technologies, Inc. DEN160020 12/21/2016
Ultravision Visual Clearing System Alesi Surgical Ltd. DEN150022 12/20/2016
Elecsys AMH, AMH CalSet, PreciControl AM ROCHE DIAGNOSTICS DEN150057 12/19/2016
Hem-Avert Perianal Stabilizer STETRIX, INC. DEN160005 12/19/2016
CleanCisionTM Wound Retraction and Prote Prescient Surgical DEN150038 12/16/2016
BD MAX Vaginal Panel, BD MAX Instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNO DEN160001 10/28/2016
APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG DEN150059 10/06/2016
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
Acclarent Aera Eustachian Tube Balloon D ACCLARENT, INC. DEN150056 09/16/2016
Modified Trevo ProVue Retriever, Trevo X CONCENTRIC MEDICAL, INC. DEN150049 09/02/2016
ImPACT Computerized Neurocognitive Concu IMPACT APPLICATIONS, INC. DEN150037 08/22/2016
Nautilus BrainPulse 1000 JAN MEDICAL, INC. DEN140040 08/01/2016
Permaseal MICRO INTERVENTIONAL DEVICES, INC. DEN150029 07/27/2016
Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. DEN160003 07/22/2016
EPIC ClearView System EPIC RESEARCH & DIAGNOSTICS, INC. DEN150004 07/15/2016
Magnetic Surgical System Levita Magnetics International Corp. DEN150007 06/13/2016
PEDIATRIC VISION SCANNER REBISCAN, INC. DEN130051 06/08/2016
WallFlex Biliary RX Fully Covered Stent BOSTON SCIENTIFIC DEN150040 06/03/2016
Cereve Sleep System CEREVE, INC. DEN140032 05/13/2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) KRONUS, INC. DEN150030 04/25/2016
GLAUCOMA COMPANION INNOVATEX, INC. DEN140022 04/20/2016
PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
Amplichek II, Negative and Amplichek II, Bio-Rad Laboratories DEN150058 03/28/2016
SENSIMED TRIGGERFISH SENSIMED AG DEN140017 03/04/2016
B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GMBH DEN150009 02/20/2016
cNEP Airway Sommetrics DEN140024 12/23/2015
Newa Skin Therapy System EndyMed Medical Ltd. DEN150005 12/18/2015
Dignitana AB DigniCap System DIGNITANA AB DEN150010 12/08/2015
RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
INVOcell INVO BIOSCIENCE DEN150008 11/02/2015
Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
FilmArray Meningitis/Encephalitis(ME) Pa BioFire Diagnostics, LLC DEN150013 10/08/2015
EarLens Contact Hearing Device EARLENS CORPORATION DEN150002 09/29/2015
ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC DEN140018 06/23/2015
BRAINPORT V100 DEVICE WICAB, INC DEN130039 06/18/2015
COGNIVUE CEREBRAL ASSESSMENT SYSTEMS, INC DEN130033 06/05/2015
NOVA View Automated Fluorescense Microsc INOVA DIAGNOSTICS, INC. DEN140039 04/09/2015
SpaceOAR System AUGMENIX , INC. DEN140030 04/01/2015
PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH SOMNA THERAPEUTICS, LLC DEN130046 03/06/2015
23ANDME PERSONAL GENOME SERVICE (HEREINA 23andMe DEN140044 02/19/2015
ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
Dexcom Share Direct Secondary Displays DEXCOM, INC. DEN140038 01/23/2015
AMIGO REMOTE CATHETER SYSTEM CATHETER ROBOTICS INC DEN140009 12/18/2014
MOERAE SURGICAL MARKING PEN MOERAE MATRIX, INC. DEN130004 12/18/2014
PERKINELMER ENLITE NEONATAL TREC TEST SY WALLAC OY DEN140010 12/15/2014
HEARTFLOW FFRCT HEARTFLOW DEN130045 11/26/2014
BrainScope Ahead 100 BRAINSCOPE COMPANY, INC DEN140025 11/17/2014
ZAP-IT! ECOBRANDS LTD. DEN100024 11/07/2014
ZANZA-CLICK TECNIMED S.R.L. DEN130019 11/07/2014
INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
T2CANDIDA AND T2DX INSTRUMENT T2 BIOSYSTEMS, INC DEN140019 09/22/2014
NEPHROCHECK TEST SYSTEM ASTUTE MEDICAL, INC DEN130031 09/05/2014
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INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA CENTERS FOR DISEASE CONTROL AND PREVENTI DEN060008 K060159 02/03/2006
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AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. DEN040011 K042259 12/23/2004
VYSIS AUTOVYSION SYSTEM VYSIS DEN040010 K041875 12/13/2004
HAMILTON THORNE ZONA INFRARED LASER OPTI HAMILTON THORNE BIOSCIENCES DEN040009 K040045 11/04/2004
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NIOX ARTICLE NO: 02-1000 AEROCRINE AB DEN030001 K021133 04/30/2003
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TrueGene HIV Genotyping Kit and OpenGene Visible Genetics, Inc. BK000038 06/27/2001
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TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) BIOSITE INCORPORATED DEN000010 K003475 11/20/2000
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