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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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Decision Date To: 01/19/2021
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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
Medtronic DUET External Drainage and Mon MEDTRONIC NEUROSURGERY DEN120017 08/22/2014
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI KRONUS MARKET DEVELOPMENT ASSOCIATES, IN DEN140001 08/20/2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFT DEXCOM, INC. DEN140016 08/19/2014
REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
EEVA 2.0 AUXOGYN, INC. DEN120015 K120427 06/06/2014
EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US DEN140002 K132379 05/29/2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASS DIAGNOSTIC HYBRIDS, INC. DEN140004 K133448 05/13/2014
DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
PIXEL 3 SYSTEM GAUSS SURGICAL, INC. DEN130015 K130190 05/09/2014
LYRA DIRECT STREP ASSAY QUIDEL CORPORATION DEN140005 K133883 04/16/2014
XSTAT REVMEDX, INC. DEN130016 K130218 04/03/2014
IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS DEN130049 K133621 03/21/2014
CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
AIRPURGE ANESTHESIA SAFETY PRODUCTS, LLC DEN080009 K080644 03/04/2014
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY GIVEN IMAGING LTD. DEN120023 K123666 01/29/2014
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018 K130313 01/17/2014
RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEE DEN110009 K102707 12/18/2013
SYMPHONY DEVICE SENSORY MEDICAL, INC DEN110011 K102873 12/18/2013
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC ENEURA THERAPEUTICS DEN130022 K130556 12/13/2013
ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. DEN130011 K123989 11/19/2013
MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. DEN130042 K133136 11/19/2013
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
VITEK MS BIOMERIEUX, INC. DEN130013 K124067 08/21/2013
QUANTITATION OF ORGANOPHOSPHATE METABOL CENTERS FOR DISEASE CONTROL AND PREVENTI DEN130005 K122282 08/08/2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN ABBOTT MOLECULAR, INC. DEN130010 K123951 07/29/2013
XPERT MTB/RIF ASSAY CEPHEID DEN130032 K131706 07/25/2013
NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC DEN110019 K112711 07/15/2013
CABOCHON SYSTEM CABOCHON AESTHETICS, INC. DEN110004 K101231 07/12/2013
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL STERIS Corporation DEN110006 K102469 07/12/2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics DEN130002 K121291 05/23/2013
X-RAY ATTENUATING CREAM BLOXR CORPORATION DEN120022 K123422 05/09/2013
FERRISCAN R2-MRI ANALYSIS SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY L DEN130012 K124065 01/23/2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH DEN090007 K082438 12/19/2012
AHIP INTERNAL TRIGGER POINT WAND MODEL: NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEN100023 K100934 11/20/2012
VIRULITE COLD SORE MACHINE VIRULITE LLC DEN090012 K083767 10/18/2012
PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. DEN120011 K113070 07/10/2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
NUCLEUS-X PTV CATHETER NUMED, INC. DEN080015 K082776 06/11/2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTI DEN120012 K113336 05/24/2012
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10 ETHICON ENDO-SURGERY DEN110016 K110431 04/30/2012
PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC DEN120013 K113358 04/30/2012
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
SYSTEM 1E PROCESS BIOLOGICAL MONITORING STERIS Corporation DEN110002 K100049 03/30/2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C PHADIA US INC. DEN120001 K103039 02/15/2012
STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. DEN120008 K112394 01/20/2012
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL VIOGUARD DEN100013 K092996 12/20/2011
INFRASCANNER, MODEL 1000 INFRASCAN, INC. DEN100002 K080377 12/13/2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR APTUS ENDOSYSTEMS, INC. DEN100026 K102333 11/21/2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMER TEARSCIENCE, INC. DEN100017 K093937 06/28/2011
APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED DEN110012 K102911 04/19/2011
DENV DETECT IGM CAPTURE ELISA INBIOS INTL., INC. DEN100020 K100534 04/08/2011
MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION DEN100025 K101699 03/31/2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA R-Biopharm AG DEN110001 K093295 02/23/2011
HEM-AVERT PERIANAL STABILIZER PLEXUS BIOMEDICAL INC. DEN090011 K083692 01/13/2011
ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL DEN090008 K082609 08/24/2010
ZELTIQ AESTHETICS DERMAL COOLING DEVICE ZELTIQ AESTHETICS DEN090002 K080521 08/24/2010
PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. DEN090005 K082289 04/30/2010
ULTHERA SYSTEM, MODEL 8850-0001 ULTHERA, INC. DEN080006 K072505 09/11/2009
OVA1 TEST VERMILLION DEN090004 K081754 09/11/2009
SNAP WOUND CARE DEVICE SPIRACUR, INC. DEN080011 K081406 08/07/2009
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D QUICK-MED TECHNOLOGIES, INC. DEN070002 K060662 02/25/2009
NEUROSTAR TMS SYSTEM NEURONETICS DEN070003 K061053 10/07/2008
ALLOMAP MOLECULAR EXPRESSION TESTING XDX DEN080007 K073482 08/26/2008
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
3M N95 HOME RESPIRATOR WITH FLUID RESIST 3M COMPANY DEN060009 K062070 05/08/2007
XPERT EV, MODEL GXEV-100N-10; GENEXPERT CEPHEID DEN070004 K061062 03/16/2007
TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. DEN060003 K052225 02/08/2007
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. DEN060006 K060028 01/30/2007
INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. DEN060007 K060070 10/12/2006
PHICAL TEST GENOVA DIAGNOSTICS DEN060001 K050007 04/26/2006
HEALTHCHECK(TM) HOME TEST FOR LOSS OF TH FMG INNOVATIONS, INC. DEN050007 K051653 03/27/2006
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA CENTERS FOR DISEASE CONTROL AND PREVENTI DEN060008 K060159 02/03/2006
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST CARDIOMEMS INC DEN050006 K050939 10/28/2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L WAKO CHEMICALS, USA, INC. DEN050002 K041847 05/19/2005
TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION DEN050004 K043011 05/09/2005
PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH DEN050003 K042613 04/18/2005
DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED DEN050001 K041482 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
HAMILTON THORNE ZONA INFRARED LASER OPTI HAMILTON THORNE BIOSCIENCES DEN040009 K040045 11/04/2004
VERICHIP HEALTH INFORMATION MICROTRANSPO DIGITAL ANGEL CORPORATION DEN040007 K033440 10/12/2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES T PERKINELMER LIFE SCIENCES, INC. DEN040002 K031878 08/24/2004
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 K034069 07/28/2004
CELLERATION MIST THERAPY SYSTEM CELLERATION DEN040004 K032378 06/25/2004
GLUCATELL ASSOCIATES OF CAPE COD, INC. DEN040003 K032373 05/21/2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI ADVANCED DIAGNOSTIC SYSTEMS DEN040001 K031588 01/21/2004
FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP. DEN030005 K033607 12/17/2003
WEST NILE VIRUS IGM CAPTURE ELISA PANBIO LIMITED DEN030004 K031703 07/08/2003
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
BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL DEN020001 K010514 01/31/2003
RETROX AURIC HEARING SYSTEMS, INC. DEN020003 K013298 08/20/2002
GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. DEN010002 K010312 08/01/2001
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) BIOSITE INCORPORATED DEN000010 K003475 11/20/2000
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