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  1. CDRH Transparency

Evaluation of Automatic Class III Designation (De Novo) Summaries

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).

There are two options for De Novo classification for novel devices of low to moderate risk.

  • Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
  • Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.

Links to all available De Novo summary documents can be found in the table below.

Device Name DEN# Classification Order Decision Summary
X100 with Full Field Bone Marrow Aspirate (BMA) Application, X100HT with Full Field Bone Marrow Aspirate (BMA) Application DEN230034 Classification Order  
Sonu DEN230045 Classification Order  
Body Temperature Software (BTS) DEN230050 Classification Order  
GeniusTM Digital Diagnostics System with the GeniusTM Cervial AI algorithm  DEN210035 Classification Order  
MIRA Surgical System DEN230025 Classification Order  
BraidE Embolization Assist Device DEN230064 Classification Order  
Technozym ADAMS13 Activity DEN230024 Classification Order  
Sleep Apnea Feature DEN230041 Classification Order  
BioTraceIO Lite DEN230020 Classification Order  
Osteoboost Belt DEN230015 Classification Order  
DermaSensor DEN230008 Classification Order  
BrainSee DEN220066 Classification Order  
Fibresolve DEN220040 Classification Order  
VerTouch Spinal Imaging Device DEN220009 Classification Order  
Edison System DEN220087 Classification Order  
EasySep Human Bone Marrow CD138 Positive Selection Kit DEN220090 Classification Order  
Dream Sock DEN220091 Classification Order  
DuraGraft Vascular Conduit Solution DEN230002 Classification Order  
LightStrike+ DEN230007 Classification Order  
AXIOS Stent and Electrocautery-Enhanced Delivery System (10 mm x 10 mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15 mm x 10 mm Stent) DEN230019 Classification Order  
ensoETM™ DEN230021 Classification Order  
Invitae Common Hereditary Cancers Panel DEN210011 Classification Order Decision Summary
Procise IFX DEN210056 Classification Order  
Procise ADL DEN220023 Classification Order  
VasQ DEN220026 Classification Order  
BrachyGel Vaginal Hydrogel Packing System DEN220052 Classification Order  
Revi System DEN220073 Classification Order  
esolution® Esophageal Retractor DEN230006 Classification Order  
Ruthless Spine RJB DEN230012 Classification Order  
KidneyIntelX.dkd DEN200052 Classification Order  
Galen ES Robotic Surgical Assistant Platform, Galen ES DEN220047 Classification Order  
BT-001 DEN220058 Classification Order  
Viz HCM DEN230003 Classification Order  
Neoasis DEN220048 Classification Order  
Eroxon DEN220078 Classification Order  
Cue COVID-19 Molecular Test DEN220028 Classification Order Decision Summary
Tristel Duo ULT DEN220041 Classification Order  
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System DEN220027 Classification Order  
Stanza DEN220083 Classification Order  
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, 
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
DEN210038 Classification Order Decision Summary
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, 
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator
DEN210040 Classification Order Decision Summary
N-SWEAT Patch DEN210055 Classification Order  
MISHA™ Knee System DEN220033 Classification Order  
NTX100 Tonic Motor Activation (NTX100 ToMAc) System DEN220059 Classification Order  
Bateman™ Bottle DEN220082 Classification Order  
Masimo SafetyNet Opioid System DEN200011 Classification Order  
RemeOsTM Screw LAG Solid DEN220030 Classification Order  
SNOO Smart Sleeper DEN210039 Classification Order  
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set DEN220039 Classification Order Decision Summary
Lenire DEN210033 Classification Order  
Caption Interpretation Automated Ejection Fraction Software DEN220063 Classification Order  
Pill Sense System DEN220065 Classification Order  
PMD-200 DEN210022 Classification Order  
Active Anthrax Detect Plus Rapid Test DEN220044 Classification Order  
RefleXion Medical Radiotherapy System (RMRS) DEN220014 Classification Order  
BioXmark DEN220017 Classification Order  
Tornier Pyrocarbon Humeral Head DEN220012 Classification Order Decision Summary  
BrainTemp Neonate (BTNeo) System DEN200042 Classification Order Decision Summary
Eonis™ SCID-SMA Kit DEN200044 Classification Order  
ScanNav Anatomy Peripheral Nerve Block DEN220024 Classification Order  
The Cooral System DEN210027 Classification Order  
Phagenyx System DEN220025 Classification Order  
Vibrant System DEN210052 Classification Order Decision Summary  
AccuMeasure™ System DEN210032 Classification Order Decision Summary 
APOLLO ESG System, APOLLO ESG SX System,
APOLLO REVISE System, APOLLO REVISE SX System
DEN210045 Classification Order Decision Summary 
Zuno Smart Sterilization Container DEN210004 Classification Order Decision Summary
ProdiGI DEN220006 Classification Order Decision Summary
Parsortix® PC1 Device DEN200062 Classification Order  
Quell-FM DEN210046 Classification Order Decision Summary
CERAMENT G DEN210044 Classification Order  
Lumipulse G β-Amyloid Ratio (1-42/1-40) DEN200072 Classification Order Decision Summary
Kerasave DEN200063 Classification Order Decision Summary
BioFire Joint Infection (JI) Panel DEN200066 Classification Order Decision Summary
ONE Male Condom DEN210034 Classification Order Decision Summary
CavaClear Laser Sheath DEN210024 Classification Order Decision Summary
POMC/PCSK1/LEPR CDx Panel DEN200059 Classification Order Decision Summary
Sunrise Sleep Disorder Diagnostic Aid DEN210015 Classification Order Decision Summary  
Comfort Marker 2.0. DEN200041 Classification Order Decision Summary
Klox Biophotonic LumiHeal System DEN200005 Classification Order Decision Summary
vPatch DEN210012 Classification Order Decision Summary
EaseVRx DEN210014 Classification Order Decision Summary
Hemolung Respiratory Assist System DEN210006 Classification Order Decision Summary
OMNIgene•GUT Dx DEN200040 Classification Order Decision Summary
MyCare Psychiatry Clozapine Assay Kit, Saladax Biomedical, Inc. DEN190028 Classification Order Decision Summary
Luminopia One DEN210005 Classification Order Decision Summary
iotaSOFT Insertion System - Drive Unit, Controller and Accessories DEN190055 Classification Order Decision Summary
Paige Prostate DEN200080 Classification Order Decision Summary
FEops HEARTguide DEN200030 Classification Order Decision Summary
OsteoProbe DEN210013 Classification Order Decision Summary
SureTune4 Software DEN210003 Classification Order Decision Summary
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System DEN200064 Classification Order Decision Summary
ADVIA Centaur Enhanced Liver Fibrosis (ELF) DEN190056 Classification Order Decision Summary
InSpace™ Subacromial Tissue Spacer System DEN200039 Classification Order Decision Summary
Portable Neuromodulation Stimulator (PoNS) DEN200050 Classification Order Decision Summary  
Cognoa ASD Diagnosis Aid DEN200069 Classification Order Decision Summary
SafeBreak® Vascular DEN190043 Classification Order Decision Summary
Oxehealth Vital Signs DEN200019 Classification Order Decision Summary
Neurolutions IpsiHand Upper Extremity Rehabilitation System DEN200046 Classification Order Decision Summary
GI Genius DEN200055 Classification Order Decision Summary
Gili Pro BioSensor DEN200038 Classification Order Decision Summary
ClearUP Sinus Relief DEN200006 Classification Order Decision Summary
Analytic for Hemodynamic Instability (AHI) DEN200022 Classification Order Decision Summary
Hominis Surgical System DEN190022 Classification Order Decision Summary
Q-Collar DEN200017 Classification Order Decision Summary
Lumenis Stellar M22 DEN200028 Classification Order Decision Summary
eXciteOSA without remote control, eXciteOSA with remote control DEN200018 Classification Order Decision Summary
EndoRotor DEN200016 Classification Order Decision Summary
Helix Laboratory Platform DEN190035 Classification Order  
BEAR® (Bridge-Enhanced ACL Repair) Implant DEN200035 Classification Order Decision Summary
Parallel DEN200029 Classification Order  
CADScor System DEN190047 Classification Order Decision Summary
FilmArray Global Fever Panel DEN200043 Classification Order Decision Summary
Acumen Assisted Fluid Management (AFM) Software Feature DEN190029 Classification Order Decision Summary
NightWare Kit (Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable) DEN200033 Classification Order Decision Summary
Theranova Dialyzers (Theranova 400, Theranova 500) DEN190042 Classification Order Decision Summary
Cell-Free DNA BCT DEN200001 Classification Order Decision Summary
cobas EBV DEN200015 Classification Order Decision Summary
EndeavorRx DEN200026 Classification Order Decision Summary
NP Screen DEN190031 Classification Order Decision Summary
CARPEDIEM System DEN180055 Classification Order  
OGmend® Implant System DEN180065 Classification Order Decision Summary
iTEAR100 Neurostimulator DEN190026 Classification Order Decision Summary
OraQuick Ebola Rapid Antigen Test DEN190025 Classification Order Decision Summary
QMS Plazomicin Immunoassay DEN180030 Classification Order Decision Summary
iTind System DEN190020 Classification Order Decision Summary
AmplideX Fragile X Dx & Carrier Screen Kit DEN190023 Classification Order Decision Summary
Caption Guidance DEN190040 Classification Order Decision Summary
The Quantra QPlus System DEN180017 Classification Order Decision Summary
Control-IQ Technology DEN190034 Classification Order Decision Summary
Surfacer Inside-Out Access Catheter System DEN190038 Classification Order  
GSP Neonatal Creatine Kinase - MM kit DEN180056 Classification Order Decision Summary
EchoTip® Insight™ Portosystemic Pressure Gradient Measuring System DEN180062 Classification Order Decision Summary
t:Slim X2 insulin pump with interoperable technology DEN180058 Classification Order Decision Summary
WOUNDCHEK Bacterial Status DEN180014 Classification Order Decision Summary
ContaCT DEN170073 Classification Order Decision Summary
QuantX DEN170022 Classification Order Decision Summary
Mucosal Integrity Conductivity (MI) Test System DEN180067 Classification Order Decision Summary
cobas vivoDx MRSA DEN190016 Classification Order Decision Summary
IB-Stim DEN180057 Classification Order Decision Summary
STUDIO on the Cloud Data Management Software DEN140016 Classification Order Decision Summary
Plenity DEN180060 Classification Order Decision Summary
Nerivio Migra DEN180059 Classification Order Decision Summary
Monarch eTNS System DEN180041 Classification Order Decision Summary
Bose Hearing Aid DEN180026 Classification Order Decision Summary
PREVENA 125 and PREVENA PLUS 125 Therapy Units DEN180013 Classification Order Decision Summary
Aptima Mycoplasma genitalium Assay DEN180047 Classification Order Decision Summary
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
DEN180032 Classification Order Decision Summary
ClearMate DEN170044 Classification Order Decision Summary
Comaneci Embolization Assist Device DEN170064 Classification Order Decision Summary
Early Bird Bleed Monitoring System DEN180021 Classification Order Decision Summary
Leica FL400 DEN180024 Classification Order Decision Summary
LOADPRO™ Intraoperative Rod Strain Sensor DEN180012 Classification Order Decision Summary
ZIKV Detect 2.0 IgM Capture ELISA DEN180069 Classification Order Decision Summary
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports DEN180028 Classification Order Decision Summary
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) DEN170046 Classification Order Decision Summary
Irregular Rhythm Notification Feature DEN180042 Classification Order Decision Summary
ECG App DEN180044 Classification Order Decision Summary
EyeBOX DEN170091 Classification Order Decision Summary
SEM Scanner DEN170021 Classification Order Decision Summary
Innovo DEN170049 Classification Order Decision Summary
Medtronic DUET™ External Drainage and Monitoring System (EDMS) DEN120017 Classification Order Decision Summary
Percutaneous Surgical Set with 5 mm or 10 mm Attachments DEN110016 Classification Order Decision Summary
ViruLite Cold Sore Machine DEN090012 Classification Order Decision Summary
picoAMH ELISA DEN180004 Classification Order Decision Summary
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System DEN170092 Classification Order Decision Summary
Alethia CMV Assay Test System DEN180040 Classification Order Decision Summary
Retrograde Intubation Set DEN170055 Classification Order Decision Summary
ENLIGHT 1810 DEN170072 Classification Order Decision Summary
MLL (KMT2A) Breakapart FISH Probe Kit
P53 (TP53) Deletion FISH Probe Kit
Del(20q) Deletion FISH Probe Kit
CBFβ (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit
Del(5q) Deletion FISH Probe Kit
Del(7q) Deletion FISH Probe Kit
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit
EVI1 (MECOM) Breakapart FISH Probe Kit
DEN170070 Classification Order Decision Summary
Miris Human Milk Analyzer DEN180007 Classification Order Decision Summary
Dexcom G6 Continuous Glucose Monitoring System DEN170088 Classification Order Decision Summary
BONEBRIDGE DEN170009 Classification Order Decision Summary
MALDI Biotyper CA System DEN170081 Classification Order Decision Summary
Hemospray® Endoscopic Hemostat DEN170015 Classification Order Decision Summary
Parathyroid Detection (Model PTeye) System DEN170056 Classification Order Decision Summary
Adaptive Biotechnologies clonoSEQ Assay DEN170080 Classification Order Decision Summary
Precision Flow® HVNI DEN170001 Classification Order Decision Summary
Acumen Hypotension Prediction Index (HPI) Feature Software DEN160044 Classification Order Decision Summary
Ellipsys Vascular Access System DEN170004 Classification Order Decision Summary
everlinQ endoAVF System DEN160006 Classification Order Decision Summary
CURVE™ Positive Airway Pressure System DEN170089 Classification Order Decision Summary
SkinPen Precision System DEN160029 Classification Order Decision Summary
dermPACE System DEN160037 Classification Order Decision Summary
PrimeStore MTM DEN170029 Classification Order Decision Summary
GeneSTAT.MDx Coccidioides Assay DEN170041 Classification Order Decision Summary
DreaMed Advisor Pro DEN170043 Classification Order Decision Summary
OsteoDetect DEN180005 Classification Order Decision Summary
MolecuLight i:X DEN180008 Classification Order Decision Summary
TrueTear Intranasal Tear Neurostimulator DEN170086 Classification Order Decision Summary
Unyvero LRT Application DEN170047 Classification Order Decision Summary
Brainsway Deep Transcranial Magnetic Stimulation System DEN170078 Classification Order Decision Summary
MATRx plus DEN170090 Classification Order Decision Summary
IDx-DR DEN180001 Classification Order Decision Summary
Cala ONE DEN170028 Classification Order Decision Summary
ThermoNeuroModulation (TNM) Device DEN170023 Classification Order Decision Summary
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay DEN170010 Classification Order Decision Summary
Natural Cycles DEN170052 Classification Order Decision Summary
IlluminOss Photodynamic Bone Stabilization System DEN160062 Classification Order Decision Summary
AQUABEAM System DEN170024 Classification Order Decision Summary
remOVE System DEN160014 Classification Order Decision Summary
NSS-2 BRIDGE DEN170018 Classification Order Decision Summary
CipherOx CRI™ Tablet DEN160020 Classification Order Decision Summary
Banyan BTI DEN170045 Classification Order Decision Summary
FilmArray Respiratory Panel 2 plus (RP2plus) DEN170017 Classification Order Decision Summary
ContainOR DEN170075 Classification Order Decision Summary
Ventana MMR IHC Panel DEN170030 Classification Order Decision Summary
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit DEN160025 Classification Order Decision Summary
reSET DEN160018 Classification Order Decision Summary
Fetal Pillow DEN150053 Classification Order Decision Summary
ClearLLab Reagents (T1, T2, B1, B2, M) DEN160047 Classification Order Decision Summary
D2 Dressing DEN160012 Classification Order  
gammaCore Non-invasive Vagus Nerve Stimulator DEN150048 Classification Order Decision Summary
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) DEN170058 Classification Order Decision Summary
23andMe Personal Genome Service (PGS) Test DEN160026 Classification Order Decision Summary
Philips IntelliSite Pathology Solution (PIPS) DEN160056 Classification Order Decision Summary
MiSeqDx Universal Kit 1.0 DEN130042 Classification Order Decision Summary
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS DEN130005 Classification Order Decision Summary
ARK Voriconazole II Assay Test System DEN160033 Classification Order Decision Summary
Embosphere Microspheres DEN160040 Classification Order Decision Summary
Sentinel® Cerebral Protection System DEN160043 Classification Order Decision Summary
Vitamin D 200M Assay for the Topaz System DEN170019 Classification Order Decision Summary
AeroForm® Tissue Expander System DEN150055 Classification Order Decision Summary
Intranasal Tear Neurostimulator DEN160030 Classification Order Decision Summary
ipsogen® JAK2 RGQ PCR Kit DEN160028 Classification Order Decision Summary
Accelerate PhenoTest BC Kit DEN160032 Classification Order Decision Summary
Brain Sentinel Monitoring and Alerting System DEN140033 Classification Order Decision Summary
CINtec Histology DEN160019 Classification Order Decision Summary
Illumina MiSeqDx Platform DEN130011 Classification Order Decision Summary
Dexcom Share Direct Secondary Displays DEN140038 Classification Order Decision Summary
SEEKER System DEN150035 Classification Order Decision Summary
Levita Magnetic Surgical System DEN150007 Classification Order Decision Summary
CleanCision™ Wound Retraction and Protection System DEN150038 Classification Order Decision Summary
Elecsys AMH System DEN150057 Classification Order Decision Summary
SENSIMED Triggerfish® DEN140017 Classification Order Decision Summary
cNEP Airway Management System DEN140024 Classification Order Decision Summary
Sensor Monitored Alimentary Restriction Therapy (SMART) Device DEN150033 Classification Order Decision Summary
Hem-Avert Perianal Stabilizer DEN160005 Classification Order Decision Summary
Ultravision™ Visual Field Clearing System DEN150022 Classification Order Decision Summary
ACCLARENT AERA™ Eustachian Tube Balloon Dilation System DEN150056 Classification Order Decision Summary
Tear Duct Occluder DEN140022 Classification Order Decision Summary
Vioguard Self-Sanitizing Keyboard (Model UVKB50) DEN100013 Classification Order Decision Summary
BD MAX Vaginal Panel DEN160001 Classification Order Decision Summary
APAS Compact DEN150059 Classification Order Decision Summary
BrainPulse, Model 1100 DEN140040 Classification Order Decision Summary
Symphony Device (Models 09-0002-01, 09-0003-01, and 09-0004-01) DEN110011 Classification Order Decision Summary
Trevo ProVue and XP ProVue Retrievers DEN150049 Classification Order Decision Summary
ImPACT and ImPACT Pediatric DEN150037 Classification Order Decision Summary
Permaseal DEN150029 Classification Order Decision Summary
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay DEN150030 Classification Order Decision Summary
QuantideX qPCR BCR-ABL IS Kit DEN160003 Classification Order Decision Summary
EPIC ClearViewTM System DEN150004 Classification Order Decision Summary
Pediatric Vision Scanner DEN130051 Classification Order Decision Summary
WallFlex Biliary RX Fully Covered Stent System RMV DEN150040 Classification Order Decision Summary
Cerêve Sleep System DEN140032 Classification Order Decision Summary
B·R·A·H·M·S PCT sensitive KRYPTOR® DEN150009 Classification Order Decision Summary
Esophageal Cooling Device DEN140018 Classification Order Decision Summary
PneumoLiner DEN150028 Classification Order Decision Summary
Amplichek II DEN150058 Classification Order Decision Summary
RELIZORB™ DEN150001 Classification Order Decision Summary
Sonablate® 450 DEN150011 Classification Order Decision Summary
EarLens™ Contact Hearing Device DEN150002 Classification Order Decision Summary
Newa™ DEN150005 Classification Order Decision Summary
INVOcell™ Intravaginal Culture System DEN150008 Classification Order Decision Summary
FilmArray® Meningitis/Encephalitis (ME) Panel DEN150013 Classification Order Decision Summary
BrainScope Ahead 100, Models CV-100 and M-100 DEN140025 Classification Order Decision Summary
EnLite™ Neonatal TREC Kit DEN140010 Classification Order Decision Summary
DigniCap™ Scalp Cooling System DEN150010 Classification Order Decision Summary
Eclipse System DEN140020 Classification Order Decision Summary
NOVA View® Automated Fluorescence Microscope DEN140039 Classification Order Decision Summary
23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom Syndrome DEN140044 Classification Order Decision Summary
Amigo® Remote Catheter System (Amigo RCS) DEN140009 Classification Order Decision Summary
Prostate Mechanical Imager (PMI) DEN100016 Classification Order Decision Summary
Cognivue DEN130033 Classification Order Decision Summary
Zanza-Click, Mini-Click, Disc-o-Click DEN130019 Classification Order Decision Summary
Reza Band® Upper Esophageal Sphincter (UES) Assist Device DEN130046 Classification Order Decision Summary
SpaceOAR System DEN140030 Classification Order Decision Summary
VasoPrep Surgical Marking Pen DEN130004 Classification Order Decision Summary
Zap-It! DEN100024 Classification Order Decision Summary
HeartFlow FFRCT v.1.4 DEN130045 Classification Order Decision Summary
Eeva® System DEN120015 Classification Order Decision Summary
Infrascanner Model 1000 DEN100002 Classification Order Decision Summary
Zeltiq™ Dermal Cooling Device DEN090002 Classification Order  
AirPurge System DEN080009 Classification Order Decision Summary
Bio-Seal Lung Biopsy Tract Plug System DEN090007 Classification Order Decision Summary
Erchonia ML Scanner DEN090008 Classification Order  
NuMED NuCLEUS and NuCLEUS-X BAV Catheters DEN080015 Classification Order Decision Summary
Hem-Avert Perianal Stabilizer DEN090011 Classification Order Decision Summary
RIDASCREEN Norovirus 3rd Generation EIA DEN110001 Classification Order  
Prostate Mechanical Imager DEN100016 Classification Order Decision Summary
LipiFlow Thermal Pulsation System DEN100017 Classification Order Decision Summary
Steris Verify Spore Test Strip for S40 DEN110002 Classification Order Decision Summary
InBios DENV Detect IgM Capture ELISA DEN100020 Classification Order Decision Summary
AHIP Internal Trigger Point Wand DEN100023 Classification Order Decision Summary
Cabochon System DEN110004 Classification Order Decision Summary
Widex C4-PA Wireless Air-Conduction Hearing Aid DEN100025 Classification Order Decision Summary
Aptus Endovascular Suturing System DEN100026 Classification Order Decision Summary
Restiffic™ Restless Leg Relaxer Foot Wrap DEN110009 Classification Order Decision Summary
ImmunoCAP Tryptase DEN120001 Classification Order Decision Summary
STRATIFY JCV Antibody ELISA DEN120008 Classification Order Decision Summary
Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System DEN110019 Classification Order Decision Summary
Proteus Personal Monitor Including Ingestion Event Marker DEN120011 Classification Order Decision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAY DEN120013 Classification Order Decision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) DEN120014 Classification Order Decision Summary
DEKA Arm System DEN120016 Classification Order Decision Summary
COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay DEN130002 Classification Order Decision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP) DEN130003 Classification Order Decision Summary
Cefaly - Transcutaneous Electrical Nerve Stimulator DEN120019 Classification Order Decision Summary
AXIOS Stent and Delivery System DEN130007 Classification Order Decision Summary
X-ray Attenuating Cream DEN120022 Classification Order Decision Summary
PillCam® COLON 2 Capsule Endoscopy System DEN120023 Classification Order Decision Summary
Vysis EGR1 FISH Probe Kit DEN130010 Classification Order Decision Summary
FerriScan R2-MRI Analysis System DEN130012 Classification Order Decision Summary
VITEK®MS DEN130013 Classification Order Decision Summary
NEPHROCHECK® Test System DEN130031 Classification Order Decision Summary
Pixel 3 System DEN130015 Classification Order Decision Summary
XSTAT DEN130016 Classification Order Decision Summary
CytoScan® Dx Assay DEN130018 Classification Order Decision Summary
Cerena Transcranial Magnetic Stimulator DEN130022 Classification Order Decision Summary
NeoTract UroLift System, Model REF UL400 DEN130023 Classification Order Decision Summary
Xpert MTB/RIF Assay DEN130032 Classification Order Decision Summary
ReWalk™ DEN130034 Classification Order Decision Summary
Prostate Immobilizer Rectal Balloon DEN130036 Classification Order Decision Summary
EUROIMMUN Anti-PLA2R IFA DEN140002 Classification Order Decision Summary
IOGYN System DEN130040 Classification Order Decision Summary
Lyra™ Direct HSV 1 + 2/VZV Assay DEN140004 Classification Order Decision Summary
Simplexa™ HSV 1 & 2 Direct DEN130049 Classification Order Decision Summary
Lyra Direct Strep Assay DEN140005 Classification Order Decision Summary
KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay DEN140001 Classification Order Decision Summary
T2Candida Panel and T2Dx® Instrument DEN140019 Classification Order Decision Summary
inFlow™ Intraurethral Valve-Pump and Activator DEN130044 Classification Order Decision Summary
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule DEN190037 Classification Order Decision Summary
ToothWave™ DEN190039 Classification Order Decision Summary
HemosIL Liquid Anti-Xa DEN190032 Classification Order Decision Summary
Spineology Interbody Fusion System DEN200010 Classification Order Decision Summary
Tangible Boost DEN200002 Classification Order Decision Summary
BioFire Respiratory Panel 2.1 (RP2.1) DEN200031 Classification Order Decision Summary

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