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