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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: 04/25/2024
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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 N95 HOME RESPIRATOR WITH FLUID RESIST 3M COMPANY DEN060009 K062070 05/08/2007
THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN ABBOTT MOLECULAR, INC. DEN130010 K123951 07/29/2013
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
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
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI ADVANCED DIAGNOSTIC SYSTEMS DEN040001 K031588 01/21/2004
PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
ContainOR Advanced Surgical Concepts Ltd. DEN170075 12/19/2017
NIOX ARTICLE NO: 02-1000 AEROCRINE AB DEN030001 K021133 04/30/2003
AFFYMETRIX GENECHIP MICROARRAY INSTRUMEN Affymetrix, Inc. DEN040012 K042279 12/23/2004
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018 K130313 01/17/2014
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
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
AIRPURGE ANESTHESIA SAFETY PRODUCTS, LLC DEN080009 K080644 03/04/2014
BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH DEN090007 K082438 12/19/2012
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
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR APTUS ENDOSYSTEMS, INC. DEN100026 K102333 11/21/2011
REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC DEN160033 05/05/2017
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
GLUCATELL ASSOCIATES OF CAPE COD, INC. DEN040003 K032373 05/21/2004
BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL DEN020001 K010514 01/31/2003
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
RETROX AURIC HEARING SYSTEMS, INC. DEN020003 K013298 08/20/2002
EEVA 2.0 AUXOGYN, INC. DEN120015 K120427 06/06/2014
Ellipsys Vascular Access System Avenu Medical, Inc DEN170004 06/22/2018
B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GMBH DEN150009 02/20/2016
SEEKER System Baebies, Inc. DEN150035 02/03/2017
Banyan BTI Banyan Biomarkers, Inc. DEN170045 02/14/2018
COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. DEN060006 K060028 01/30/2007
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
VITEK MS BIOMERIEUX, INC. DEN130013 K124067 08/21/2013
RemeOs™ Screw LAG Solid Bioretec Ltd. DEN220030 03/29/2023
Sepax Cell Separation System and Single Biosafe SA BK060036 01/03/2007
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) BIOSITE INCORPORATED DEN000010 K003475 11/20/2000
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
X-RAY ATTENUATING CREAM BLOXR CORPORATION DEN120022 K123422 05/09/2013
Surfacer Inside-Out Access Catheter Syst Bluegrass Vascular Technologies, Inc. DEN190038 02/10/2020
Revi System 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 sFlt-1/ PlGF KRYPTOR Test Sy BRAHMS GmbH, Part of Thermo Fisher Scien DEN220027 05/18/2023
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
BrainScope Ahead 100 BRAINSCOPE COMPANY, INC DEN140025 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
CABOCHON SYSTEM CABOCHON AESTHETICS, INC. DEN110004 K101231 07/12/2013
Cala ONE Cala Health, Inc. DEN170028 04/26/2018
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
The N-SWEAT Patch Candesant Biomedical, Inc. DEN210055 04/07/2023
Caption Interpretation Automated Ejectio Caption Health, Inc DEN220063 02/24/2023
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST CARDIOMEMS INC DEN050006 K050939 10/28/2005
AMIGO REMOTE CATHETER SYSTEM CATHETER ROBOTICS INC DEN140009 12/18/2014
Synovasure Alpha Defensin Lateral Flow T CD Diagnostics Inc. DEN180032 05/23/2019
CELLERATION MIST THERAPY SYSTEM CELLERATION DEN040004 K032378 06/25/2004
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA CENTERS FOR DISEASE CONTROL AND PREVENTI DEN060008 K060159 02/03/2006
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR CENTERS FOR DISEASE CONTROL AND PREVENTI DEN070001 09/21/2018
CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTI DEN120012 K113336 05/24/2012
QUANTITATION OF ORGANOPHOSPHATE METABOL CENTERS FOR DISEASE CONTROL AND PREVENTI DEN130005 K122282 08/08/2013
Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTI DEN160016 02/06/2017
XPERT EV, MODEL GXEV-100N-10; GENEXPERT CEPHEID DEN070004 K061062 03/16/2007
XPERT MTB/RIF ASSAY CEPHEID DEN130032 K131706 07/25/2013
COGNIVUE CEREBRAL ASSESSMENT SYSTEMS, INC DEN130033 06/05/2015
Cereve Sleep System CEREVE, INC. DEN140032 05/13/2016
Sentinel Cerebral Protection System Claret Medical, Inc. DEN160043 06/01/2017
APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG DEN150059 10/06/2016
PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. DEN090005 K082289 04/30/2010
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 06/13/2022
DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC CRANIAL TECHNOLOGIES, INC. DEN980001 K964992 05/29/1998
Cue COVID-19 Molecular Test Cue Health Inc. DEN220028 06/06/2023
Curetis Unyvero LRT Application Curetis GmbH DEN170047 04/03/2018
MLL (KMT2A) Breakapart FISH Probe Kit; A Cytocell Ltd DEN170070 12/21/2018
BrainSee Darmiyan, Inc. DEN220066 01/11/2024
DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
DermaSensor DermaSensor Inc. DEN230008 01/12/2024
STUDIO ON THE CLOUD DATA MANAGEMENT SOFT DEXCOM, INC. DEN140016 08/19/2014
Dexcom Share Direct Secondary Displays DEXCOM, INC. DEN140038 01/23/2015
Dexcom G6 Continuous Glucose Monitoring Dexcom, Inc. DEN170088 03/27/2018
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASS DIAGNOSTIC HYBRIDS, INC. DEN140004 K133448 05/13/2014
DIAMOND PROBE/PERIO 2000 SYSTEM DIAMOND GENERAL DEVELOPMENT CORP. DEN980003 K980749 07/17/1998
VERICHIP HEALTH INFORMATION MICROTRANSPO DIGITAL ANGEL CORPORATION DEN040007 K033440 10/12/2004
Dignitana AB DigniCap System DIGNITANA AB DEN150010 12/08/2015
Mucosal Integrity Conductivity (MI) Test Diversatek Healthcare Inc. DEN180067 12/23/2019
OMNIgene GUT Dx DNA Genotek Inc. DEN200040 11/03/2021
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 04/14/2017
Newa Skin Therapy System EndyMed Medical Ltd. DEN150005 12/18/2015
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC ENEURA THERAPEUTICS DEN130022 K130556 12/13/2013
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
EPIC ClearView System EPIC RESEARCH & DIAGNOSTICS, INC. DEN150004 07/15/2016
ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL DEN090008 K082609 08/24/2010
PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10 ETHICON ENDO-SURGERY DEN110016 K110431 04/30/2012
EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US DEN140002 K132379 05/29/2014
FEops HEARTguide FEops NV DEN200030 09/08/2021
Analytic for Hemodynamic Instability (AH Fifth Eye Inc. DEN200022 03/01/2021
Body Temperature Software (BTS) Fitbit LLC DEN230050 12/15/2023
CipherOx CRI Tablet Flashback Technologies, Inc. DEN160020 12/21/2016
Fluobeam 800 Clinic Imaging Device used Fluoptics DEN170092 11/02/2018
HEALTHCHECK(TM) HOME TEST FOR LOSS OF TH FMG INNOVATIONS, INC. DEN050007 K051653 03/27/2006
SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS DEN130049 K133621 03/21/2014
STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. DEN120008 K112394 01/20/2012
Curve Positive Airway Pressure System FRESCA Medical DEN170089 06/05/2018
Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics, Inc. DEN200072 05/04/2022
Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
Galen ES Cooperative Surgical Assistant Galen Robotics DEN220047 07/19/2023
PIXEL 3 SYSTEM GAUSS SURGICAL, INC. DEN130015 K130190 05/09/2014
Breast Implant Removal Device (BIRD) Gaylord Solutions, LLC DEN220082 04/20/2023
Plenity Gelesis, Inc. DEN180060 04/12/2019
APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED DEN110012 K102911 04/19/2011
BD MAX Vaginal Panel, BD MAX Instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNO DEN160001 10/28/2016
PHICAL TEST GENOVA DIAGNOSTICS DEN060001 K050007 04/26/2006
GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. DEN010002 K010312 08/01/2001
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY GIVEN IMAGING LTD. DEN120023 K123666 01/29/2014
ONE Male Condom Global Protection Corp. DEN210034 02/23/2022
PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC DEN120013 K113358 04/30/2012
HAMILTON THORNE ZONA INFRARED LASER OPTI HAMILTON THORNE BIOSCIENCES DEN040009 K040045 11/04/2004
SNOO Smart Sleeper Happiest Baby, Inc. DEN210039 03/30/2023
HEARTFLOW FFRCT HEARTFLOW DEN130045 11/26/2014
Portable Neuromodulation Stimulator (PoN Helius Medical, Inc. DEN200050 03/26/2021
Helix Laboratory Platform Helix OpCo, LLC DEN190035 12/23/2020
Hemanext ONE Hemanext, Inc. BR220665 09/15/2023
Quantra Hemostasis Analyzer, QPlus Cartr HemoSonics, LLC DEN180017 03/12/2019
Edison System HistoSonics, Inc. DEN220087 10/06/2023
“Genius™ Digital Diagnostics System with Hologic Inc. DEN210035 01/31/2024
Aptima Mycoplasma genitalium Assay Hologic, Inc. DEN180047 01/23/2019
ToothWave™ Home Skinovations Ltd. DEN190039 09/17/2020
ID-FISH Plasmodium Genus Test Kit, ID-FI ID-FISH TECHNOLOGY, INC DEN160025 08/18/2017
IDx-DR IDx, LLC DEN180001 04/11/2018
IlluminOss Bone Stabilization System IllminOss Medical, Inc. DEN160062 12/19/2017
ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. DEN130011 K123989 11/19/2013
MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. DEN130042 K133136 11/19/2013
OsteoDetect Imagen Technologies, Inc. DEN180005 05/24/2018
ImPACT Computerized Neurocognitive Concu IMPACT APPLICATIONS, INC. DEN150037 08/22/2016
Fibresolve Imvaria, Inc DEN220040 01/12/2024
ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. DEN180069 05/23/2019
Active Anthrax DetectTM Plus Rapid Test InBios International, Inc. DEN220044 02/03/2023
DENV DETECT IGM CAPTURE ELISA INBIOS INTL., INC. DEN100020 K100534 04/08/2011
INFRASCANNER, MODEL 1000 INFRASCAN, INC. DEN100002 K080377 12/13/2011
GLAUCOMA COMPANION INNOVATEX, INC. DEN140022 04/20/2016
NSS-2 System Innovative Health Solutions (IHS), Inc. DEN170018 11/15/2017
IB-Stim Innovative Health Solutions (IHS), Inc. DEN180057 06/07/2019
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI INOVA DIAGNOSTICS, INC. DEN000007 K000732 08/16/2000
NOVA View Automated Fluorescense Microsc INOVA DIAGNOSTICS, INC. DEN140039 04/09/2015
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
HemosIL Liquid Anti-Xa Instrumentation Laboratory Co. DEN190032 09/17/2020
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
VerTouch Spinal Imaging Device IntuiTap Medical, Inc. DEN220009 01/19/2024
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
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
IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
iotaSOFT Insertion System - Drive Unit, IotaMotion, Inc. DEN190055 10/01/2021
Nautilus BrainPulse 1000 JAN MEDICAL, INC. DEN140040 08/01/2016
KAVO DIAGNODENT KAVO AMERICA DEN990002 K983658 02/22/2000
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
Klox Biophotonic LumiHeal System Klox Technlogies Inc. DEN200005 12/03/2021
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI KRONUS MARKET DEVELOPMENT ASSOCIATES, IN DEN140001 08/20/2014
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
NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC DEN110019 K112711 07/15/2013
Companion LGCH, INC DEN140033 02/16/2017
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
LZI Carisoprodol Metabolite (Meprobamate Lin-Zhi International, Inc. DEN170010 04/20/2018
PrimeStore MTM Longhorn Vaccines and Diagnostics LLC DEN170029 03/19/2018
Lumenis Stellar M22 Lumenis Ltd. DEN200028 02/23/2021
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 K993284 02/29/2000
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. DEN060007 K060070 10/12/2006
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEE DEN110009 K102707 12/18/2013
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 B.V. 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 11/15/2017
Alethia CMV DNA Amplification Assay, Ale Meridian Bioscience, Inc. DEN180040 11/30/2018
BEAR (Bridge-Enhanced ACL Repair) Implan Miach Orthopaedics, Inc. DEN200035 12/16/2020
Permaseal MICRO INTERVENTIONAL DEVICES, INC. DEN150029 07/27/2016
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 K034069 07/28/2004
QMS Plazomicin Immunoassay Microgenics Corporation DEN180030 11/19/2018
Miris Human Milk Analyzer Miris AB DEN180007 12/21/2018
Symani Surgical System MMI North America, Inc. DEN230032 04/05/2024
MOERAE SURGICAL MARKING PEN MOERAE MATRIX, INC. DEN130004 12/18/2014
MolecuLight i:X MolecuLight Inc. DEN180008 07/31/2018
MISHA Knee System Moximed, Inc. DEN220033 04/10/2023
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
BioXmark Nanovi A/S DEN220017 12/23/2022
AHIP INTERNAL TRIGGER POINT WAND MODEL: NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEN100023 K100934 11/20/2012
Natural Cycles Natural Cycles Nordic AB DEN170052 08/10/2018
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
Neurolutions Upper Extremity Rehabilitat 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
NEUROSTAR TMS SYSTEM NEURONETICS DEN070003 K061053 10/07/2008
Monarch eTNS System NeuroSigma, Inc DEN180041 04/19/2019
NightWare Kit, Apple iPhone, Apple Watch NightWare, Inc DEN200033 11/06/2020
NTX100 Tonic Motor Activation (NTX100 To Noctrix Health, Inc. DEN220059 04/17/2023
NUCLEUS-X PTV CATHETER NUMED, INC. DEN080015 K082776 06/11/2012
Oculeve Intranasal Tear Neurostimulator OCULEVE, INC. DEN160030 04/24/2017
EyeBOX Oculogica, Inc. DEN170091 12/28/2018
WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION DEN100025 K101699 03/31/2011
OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL DEN000001 K974562 01/11/2000
iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
ELEOSx™ Limb Salvage System Onkos Surgical DEN210058 04/05/2024
OraQuick Ebola Rapid Antigen Test OraSure Technologies, Inc. DEN190025 10/10/2019
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
InSpace Subacromial Tissue Spacer System 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 Baby Care, Inc. DEN220091 11/08/2023
Oxehealth Vital Signs Oxehealth Limited DEN200019 03/26/2021
Paige Prostate Paige.AI DEN200080 09/21/2021
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