Orca1

Data catalog

De Novo classification requests

About 493 records

All records

Every De Novo record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. BR190330Sentosa SQ HIV Genotyping Assay
  2. BR220665Hemanext ONE
  3. BR220737SeCore CDx HLA Sequencing System
  4. DEN000001OHMEDA INOVENT DELIVERY SYSTEM
  5. DEN000002UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
  6. DEN000004QUICKAIR CHOKE RELIEVER, MODEL 59-001A
  7. DEN000006EROS-CLITORAL THERAPY DEVICE (CTD)
  8. DEN000007QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
  9. DEN000008DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
  10. DEN000010TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
  11. DEN010002GIVEN DIAGNOSTIC IMAGING SYSTEM
  12. DEN020001BREASTVIEW VISUAL MAPPING SYSTEM
  13. DEN020003RETROX
  14. DEN030001NIOX ARTICLE NO: 02-1000
  15. DEN030002ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
  16. DEN030004WEST NILE VIRUS IGM CAPTURE ELISA
  17. DEN030005FACTOR V LEIDEN KIT
  18. DEN040001CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
  19. DEN040002NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
  20. DEN040003GLUCATELL
  21. DEN040004CELLERATION MIST THERAPY SYSTEM
  22. DEN040007VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
  23. DEN040008CEDIA SIROLIMUS ASSAY
  24. DEN040009HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
  25. DEN040010VYSIS AUTOVYSION SYSTEM
  26. DEN040011AMPLICHIP CYP450 TEST, MODEL 04381866190
  27. DEN040012AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
  28. DEN050001DECAPINOL ORAL RINSE
  29. DEN050002LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
  30. DEN050003PAXGENE BLOOD RNA SYSTEM
  31. DEN050004TAG-IT CYSTIC FIBROSIS KIT
  32. DEN050006CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
  33. DEN050007HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
  34. DEN060001PHICAL TEST
  35. DEN060002INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
  36. DEN060003TEPHAFLEX ABSORBABLE SUTURE
  37. DEN060006COMPUTERIZED LABOR MONITORING SYSTEM
  38. DEN060007INTROL CF PANEL I CONTROL
  39. DEN060008INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
  40. DEN0600093M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR
  41. DEN070001NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
  42. DEN070002QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
  43. DEN070003NEUROSTAR TMS SYSTEM
  44. DEN070004XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145…
  45. DEN070006BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
  46. DEN070009MAMMAPRINT
  47. DEN070013ID-TAG RESPIRATORY VIRAL PANEL
  48. DEN070014MANDOMETER III
  49. DEN080006ULTHERA SYSTEM, MODEL 8850-0001
  50. DEN080007ALLOMAP MOLECULAR EXPRESSION TESTING
  51. DEN080009AIRPURGE
  52. DEN080011SNAP WOUND CARE DEVICE
  53. DEN080015NUCLEUS-X PTV CATHETER
  54. DEN090002ZELTIQ AESTHETICS DERMAL COOLING DEVICE
  55. DEN090004OVA1 TEST
  56. DEN090005PRINEO SKIN CLOSURE SYSTEM
  57. DEN090007BIO-SEAL LUNG BIOPSY TRACT SYSTEM
  58. DEN090008ERCHONIA ML SCANNER (MLS)
  59. DEN090011HEM-AVERT PERIANAL STABILIZER
  60. DEN090012VIRULITE COLD SORE MACHINE
  61. DEN100002INFRASCANNER, MODEL 1000
  62. DEN100013VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50
  63. DEN100016PROSTATE MECHANICAL IMAGER
  64. DEN100017LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
  65. DEN100020DENV DETECT IGM CAPTURE ELISA
  66. DEN100023AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
  67. DEN100024ZAP-IT!
  68. DEN100025WIDEXLINK IN CLEAR SERIES HEARING AIDS
  69. DEN100026APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE…
  70. DEN110001RIDASCREEN NOROVIRUS 3RD GENERATION EIA
  71. DEN110002SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
  72. DEN110004CABOCHON SYSTEM
  73. DEN110006VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
  74. DEN110009RESTLESS LEG DEVICE
  75. DEN110011SYMPHONY DEVICE
  76. DEN110012APTIMA TRICHOMONAS VAGINALIS ASSAY
  77. DEN110016PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
  78. DEN110019NEBA SYSTEM
  79. DEN120001IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE…
  80. DEN120008STRATIFY JCV(TM) ANTIBODY
  81. DEN120011PROTEUS INGESTION CONFINMATION SYSTEMS
  82. DEN120012CDC DENV-1-4 REAL TIME RT-PCT ASSAY
  83. DEN120013PORTRAIT ANALYZER
  84. DEN120014VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
  85. DEN120015EEVA 2.0
  86. DEN120016DEKA ARM SYSTEM
  87. DEN120017Medtronic DUET External Drainage and Monitoring System
  88. DEN120019CEFALY
  89. DEN120022X-RAY ATTENUATING CREAM
  90. DEN120023GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
  91. DEN130002TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
  92. DEN130003XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
  93. DEN130004MOERAE SURGICAL MARKING PEN
  94. DEN130005QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
  95. DEN130007AXIOS STENT AND DELIVERY SYSTEM
  96. DEN130010VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
  97. DEN130011ILLUMINA MISEQDX PLATFORM
  98. DEN130012FERRISCAN R2-MRI ANALYSIS SYSTEM
  99. DEN130013VITEK MS
  100. DEN130015PIXEL 3 SYSTEM
  101. DEN130016XSTAT
  102. DEN130018CYTOSCAN(R) DX
  103. DEN130019ZANZA-CLICK
  104. DEN130022NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
  105. DEN130023UROLIFT SYSTEM
  106. DEN130031NEPHROCHECK TEST SYSTEM
  107. DEN130032XPERT MTB/RIF ASSAY
  108. DEN130033COGNIVUE
  109. DEN130034REWALK
  110. DEN130036PROSTATE IMMOBILIZER RECTAL BALLOON
  111. DEN130039BRAINPORT V100 DEVICE
  112. DEN130040IOGYN SYSTEM
  113. DEN130042MISEQDX UNIVERSAL KIT 1.0
  114. DEN130044INFLOW INTRAURETHRAL VALVE-PUMP
  115. DEN130045HEARTFLOW FFRCT
  116. DEN130046REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
  117. DEN130047PROLONG
  118. DEN130049SIMPLEXA HSV 1&2 DIRECT
  119. DEN130051PEDIATRIC VISION SCANNER
  120. DEN140001ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
  121. DEN140002EUROIMMUN ANTI-PLA2R IFA
  122. DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
  123. DEN140005LYRA DIRECT STREP ASSAY
  124. DEN140009AMIGO REMOTE CATHETER SYSTEM
  125. DEN140010PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
  126. DEN140016STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
  127. DEN140017SENSIMED TRIGGERFISH
  128. DEN140018ESOPHAGEAL COOLING DEVICE
  129. DEN140019T2CANDIDA AND T2DX INSTRUMENT
  130. DEN140020ECLIPSE SYSTEM
  131. DEN140022GLAUCOMA COMPANION
  132. DEN140024cNEP Airway
  133. DEN140025BrainScope Ahead 100
  134. DEN140030SpaceOAR System
  135. DEN140032Cereve Sleep System
  136. DEN140033Companion
  137. DEN140038Dexcom Share Direct Secondary Displays
  138. DEN140039NOVA View Automated Fluorescense Microscope
  139. DEN140040Nautilus BrainPulse 1000
  140. DEN14004423ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
  141. DEN150001RELIZORB
  142. DEN150002EarLens Contact Hearing Device
  143. DEN150004EPIC ClearView System
  144. DEN150005Newa Skin Therapy System
  145. DEN150007Magnetic Surgical System
  146. DEN150008INVOcell
  147. DEN150009B.R.A.H.M.S PCT sensitive KRYPTOR
  148. DEN150010Dignitana AB DigniCap System
  149. DEN150011Sonablate 450
  150. DEN150013FilmArray Meningitis/Encephalitis(ME) Panel
  151. DEN150022Ultravision Visual Clearing System
  152. DEN150028PneumoLiner
  153. DEN150029Permaseal
  154. DEN150030KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
  155. DEN150033Sensor Monitored Alimentary Restriction Therapy (SMART) Device
  156. DEN150035SEEKER System
  157. DEN150037ImPACT Computerized Neurocognitive Concussion Management Aid
  158. DEN150038CleanCisionTM Wound Retraction and Protection System
  159. DEN150040WallFlex Biliary RX Fully Covered Stent System RMV
  160. DEN150048gammaCore Non-invasive Vagus Nerve Stimulator
  161. DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue…
  162. DEN150053FETAL PILLOW
  163. DEN150055AeroForm Tissue Expander System
  164. DEN150056Acclarent Aera Eustachian Tube Balloon Dilation System
  165. DEN150057Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
  166. DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and…
  167. DEN150059APAS Compact with Urine Analysis Module
  168. DEN160001BD MAX Vaginal Panel, BD MAX Instrument
  169. DEN160003Quantidex qPCR BCR-ABL IS Kit
  170. DEN160005Hem-Avert Perianal Stabilizer
  171. DEN160006everlinQ endoAVF System
  172. DEN160012D2 Dressing
  173. DEN160014remOVE System
  174. DEN160016Variola virus Real-Time PCR Assay
  175. DEN160018reSet
  176. DEN160019CINtec Histology (50 tests), CINtec Histology (250 tests)
  177. DEN160020CipherOx CRI Tablet
  178. DEN160025ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test…
  179. DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary…
  180. DEN160028ipsogen JAK2 RGQ PCR Kit
  181. DEN160029SkinPen Precision System
  182. DEN160030Oculeve Intranasal Tear Neurostimulator Device
  183. DEN160032Accelerate Pheno system, Accelerate Phenotest BC Kit
  184. DEN160033ARK Voriconazole II Assay Test System
  185. DEN160037dermaPACE System
  186. DEN160040Embosphere Microspheres
  187. DEN160043Sentinel Cerebral Protection System
  188. DEN160044Acumen Hypotension Prediction Index (HPI) Feature Software
  189. DEN160047ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
  190. DEN160048FilmArray NGDS Warrior Panel
  191. DEN160056Philips IntelliSite Pathology Solution
  192. DEN160062IlluminOss Bone Stabilization System
  193. DEN170001Precision Flow® HVNI
  194. DEN170004Ellipsys Vascular Access System
  195. DEN170009Bonebridge
  196. DEN170010LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
  197. DEN170015Hemospray Endoscopic Hemostat
  198. DEN170017FilmArray Respiratory Panel 2 plus (RP2plus)
  199. DEN170018NSS-2 System
  200. DEN170019Vitamin D 200M Assay for the Topaz System
  201. DEN170021SEM Scanner (Model 200)
  202. DEN170022QuantX
  203. DEN170023ThermoNeuroModulation Device, TNM Device
  204. DEN170024AQUABEAM System
  205. DEN170028Cala ONE
  206. DEN170029PrimeStore MTM
  207. DEN170030VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse…
  208. DEN170041GeneSTAT.MDx Coccidioides Assay
  209. DEN170043DreaMed Advisor Pro
  210. DEN170044ClearMate
  211. DEN170045Banyan BTI
  212. DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
  213. DEN170047Curetis Unyvero LRT Application
  214. DEN170049Innovo
  215. DEN170052Natural Cycles
  216. DEN170055Retrograde Intubation Set
  217. DEN170056Parathyroid Detection (Model PTeye) System
  218. DEN170058MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a…
  219. DEN170064Comaneci, Comaneci Petit, Comaneci 17
  220. DEN170070MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53)…
  221. DEN170072Enlight 1810
  222. DEN170073ContaCT
  223. DEN170075ContainOR
  224. DEN170078Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
  225. DEN170080Adaptive Biotechnologies clonoSEQ Assay
  226. DEN170081MALDI Biotyper CA System
  227. DEN170086TrueTear Intranasal Tear Neurostimulator
  228. DEN170088Dexcom G6 Continuous Glucose Monitoring System
  229. DEN170089Curve Positive Airway Pressure System
  230. DEN170090MATRx plus
  231. DEN170091EyeBOX
  232. DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
  233. DEN180001IDx-DR
  234. DEN180004picoAMH ELISA
  235. DEN180005OsteoDetect
  236. DEN180007Miris Human Milk Analyzer
  237. DEN180008MolecuLight i:X
  238. DEN180012LOADPRO™ Intraoperative Rod Strain Sensor
  239. DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy Units
  240. DEN180014WOUNDCHEK Bacterial Status
  241. DEN180017Quantra Hemostasis Analyzer, QPlus Cartridge
  242. DEN180021Early Bird Bleed Monitoring System
  243. DEN180024Leica FL400
  244. DEN180026Bose Hearing Aid
  245. DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic Reports
  246. DEN180030QMS Plazomicin Immunoassay
  247. DEN180032Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow…
  248. DEN180040Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
  249. DEN180041Monarch eTNS System
  250. DEN180042Irregular Rhythm Notification Feature
  251. DEN180044ECG App
  252. DEN180047Aptima Mycoplasma genitalium Assay
  253. DEN180055CARPEDIEM System
  254. DEN180056GSP Neonatal Creatine Kinase - MM kit
  255. DEN180057IB-Stim
  256. DEN180058t:slim X2 insulin pump with interoperable technology
  257. DEN180059Nerivio Migra
  258. DEN180060Plenity
  259. DEN180062EchoTip Insight Portosystemic Pressure Gradient Measuring System
  260. DEN180065OGmend Implant System
  261. DEN180067Mucosal Integrity Conductivity (MI) Test System
  262. DEN180069ZIKV Detect 2.0 IgM Capture ELISA
  263. DEN190016cobas vivoDx MRSA
  264. DEN190020iTind System
  265. DEN190022Hominis Surgical System
  266. DEN190023AmplideX Fragile X Dx & Carrier Screen Kit
  267. DEN190025OraQuick Ebola Rapid Antigen Test
  268. DEN190026iTEAR Neurostimulator
  269. DEN190028MyCare Psychiatry Clozapine Assay Kit
  270. DEN190029Acumen Assisted Fluid Management (AFM) Software Feature
  271. DEN190031NP Screen
  272. DEN190032HemosIL Liquid Anti-Xa
  273. DEN190034Control-IQ Technology
  274. DEN190035Helix Laboratory Platform
  275. DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
  276. DEN190038Surfacer Inside-Out Access Catheter System
  277. DEN190039ToothWave™
  278. DEN190040Caption Guidance
  279. DEN190042Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
  280. DEN190043SafeBreak Vascular
  281. DEN190047CADScor System
  282. DEN190055iotaSOFT Insertion System - Drive Unit, Controller and Accessories
  283. DEN190056ADVIA Centaur Enhanced Liver Fibrosis (ELF)
  284. DEN200001Cell-Free DNA BCT
  285. DEN200002Tangible Boost
  286. DEN200005Klox Biophotonic LumiHeal System
  287. DEN200006ClearUP Sinus Relief
  288. DEN200010Spineology Interbody Fusion System
  289. DEN200011Masimo SafetyNet
  290. DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
  291. DEN200016EndoRotor Device
  292. DEN200017Q-Collar
  293. DEN200018eXciteOSA with remote and eXciteOSA without remote
  294. DEN200019Oxehealth Vital Signs
  295. DEN200022Analytic for Hemodynamic Instability (AHI)
  296. DEN200026EndeavorRx
  297. DEN200028Lumenis Stellar M22
  298. DEN200029Parallel
  299. DEN200030FEops HEARTguide
  300. DEN200031BioFire Respiratory Panel 2.1 (RP2.1)
  301. DEN200033NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch…
  302. DEN200035BEAR (Bridge-Enhanced ACL Repair) Implant
  303. DEN200038Gili Pro BioSensor (also known as “Gili BioSensor System”)
  304. DEN200039InSpace Subacromial Tissue Spacer System
  305. DEN200040OMNIgene GUT Dx
  306. DEN200041Comfort Marker 2.0.
  307. DEN200042BrainTemp Neonate System (BTNeo System)
  308. DEN200043FilmArray Global Fever Panel
  309. DEN200044Eonis SCID-SMA Kit
  310. DEN200046Neurolutions Upper Extremity Rehabilitation System
  311. DEN200050Portable Neuromodulation Stimulator (PoNS)
  312. DEN200052KidneyIntelX.dkd
  313. DEN200055GI Genius
  314. DEN200059POMC/PCSK1/LEPR CDx Panel
  315. DEN200062Parsortix PC1 Device
  316. DEN200063Kerasave
  317. DEN200064Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
  318. DEN200066BioFire Joint Infection (JI) Panel
  319. DEN200067INNOVANCE VWF Ac
  320. DEN200069Cognoa ASD Diagnosis Aid
  321. DEN200070Simple 2 Test
  322. DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)
  323. DEN200076ORi
  324. DEN200080Paige Prostate
  325. DEN210003SureTune4 Software
  326. DEN210004Zuno Smart Sterilization Container
  327. DEN210005Luminopia One
  328. DEN210006Hemolung Respiratory Assist System
  329. DEN210011Invitae Common Hereditary Cancers Panel
  330. DEN210012vPatch
  331. DEN210013OsteoProbe
  332. DEN210014EaseVRx
  333. DEN210015Sunrise Sleep Disorder Diagnostic Aid
  334. DEN210022PMD-200
  335. DEN210024CavaClear Laser Sheath
  336. DEN210027The Cooral System
  337. DEN210032AccuMeasure System
  338. DEN210033Lenire Tinnitus Treatment Device
  339. DEN210034ONE Male Condom
  340. DEN210035“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
  341. DEN210037SoClean 3+ Bacterial Reduction Device
  342. DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic…
  343. DEN210039SNOO Smart Sleeper
  344. DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS…
  345. DEN210044CERAMENT G
  346. DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
  347. DEN210046Quell-FM
  348. DEN210049Medline ART Skin Harvesting System
  349. DEN210052Vibrant System
  350. DEN210055The N-SWEAT Patch
  351. DEN210056Procise IFX
  352. DEN210058ELEOSx™ Limb Salvage System
  353. DEN220006ProdiGI
  354. DEN220009VerTouch Spinal Imaging Device
  355. DEN220012Tornier Pyrocarbon Humeral Head
  356. DEN220014RefleXion Medical Radiotherapy System (RMRS)
  357. DEN220015Orthobond Mariner Pedicle Screw System
  358. DEN220017BioXmark
  359. DEN220023Procise ADL
  360. DEN220024ScanNav Anatomy Peripheral Nerve Block
  361. DEN220025Phagenyx System
  362. DEN220026VasQ
  363. DEN220027B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
  364. DEN220028Cue COVID-19 Molecular Test
  365. DEN220030RemeOs™ Screw LAG Solid
  366. DEN220033MISHA Knee System
  367. DEN220039Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
  368. DEN220040Fibresolve
  369. DEN220041Tristel Duo ULT
  370. DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon…
  371. DEN220044Active Anthrax DetectTM Plus Rapid Test
  372. DEN220047Galen ES Cooperative Surgical Assistant Platform, Galen ES
  373. DEN220048Neoasis
  374. DEN220052BrachyGel Vaginal Hydrogel Packing System
  375. DEN220058BT-001
  376. DEN220059NTX100 Tonic Motor Activation (NTX100 ToMAc) System
  377. DEN220063Caption Interpretation Automated Ejection Fraction Software
  378. DEN220065Pill Sense System
  379. DEN220066BrainSee
  380. DEN220073Revi System
  381. DEN220077ProSense System
  382. DEN220078Eroxon
  383. DEN220082Breast Implant Removal Device (BIRD)
  384. DEN220083Stanza
  385. DEN220087Edison System
  386. DEN220090EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
  387. DEN220091Dream Sock
  388. DEN230002DuraGraft
  389. DEN230003Viz HCM
  390. DEN230006esolution
  391. DEN230007LightStrike+ (MXSUV1-SL and MXSUV1-FT)
  392. DEN230008DermaSensor
  393. DEN230011OcuCool
  394. DEN230012Ruthless Spine RJB
  395. DEN230015Osteoboost Belt
  396. DEN230019AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent…
  397. DEN230020BioTraceIO Lite
  398. DEN230021ensoETM
  399. DEN230023Rho
  400. DEN230024Technozym ADAMTS13 Activity
  401. DEN230025MIRA Surgical System
  402. DEN230027NaviCam ProScan
  403. DEN230032Symani Surgical System
  404. DEN230034X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone…
  405. DEN230035DentalMonitoring
  406. DEN230036Sepsis ImmunoScore
  407. DEN230041Sleep Apnea Feature
  408. DEN230043Notal Vision Home Optical Coherence Tomography (OCT) System
  409. DEN230045Sonu
  410. DEN230046PGDx elio plasma focus Dx
  411. DEN230050Body Temperature Software (BTS)
  412. DEN230051Myocene
  413. DEN230052Eversense AP CGM System
  414. DEN230055FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
  415. DEN230061allay Nerve Cap
  416. DEN230064BraidE Embolization Assist Device
  417. DEN230067Chronos®
  418. DEN2300683M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™…
  419. DEN230069Mi-CHORD System
  420. DEN230076Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460…
  421. DEN230078Versius Surgical System
  422. DEN230081Hearing Aid Feature (HAF)
  423. DEN230082Stone Clear (SC-LP9-01)
  424. DEN230083Valeda Light Delivery System
  425. DEN230084Dexter L6 System
  426. DEN230085VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
  427. DEN230087AMStent® Tracheobronchial Covered Stent System
  428. DEN230090First To Know Syphilis Test
  429. DEN230092Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris…
  430. DEN240007BioHealx Anal Fistula Device
  431. DEN240013MagDI System
  432. DEN240014ARC-EX System
  433. DEN240016Xpert HCV; GeneXpert Xpress System
  434. DEN240017ShortCut
  435. DEN240018CORIS System
  436. DEN240020Visby Medical Women's Sexual Health Test
  437. DEN240021Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model…
  438. DEN240023SmartFlow Neuro Cannula
  439. DEN240025VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
  440. DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen Test
  441. DEN240031Prapela SVS hospital bassinet pad (model P01)
  442. DEN240032APO-Easy Genotyping kit
  443. DEN240035ConcizuTrace™ ELISA
  444. DEN240038Oxiplex®
  445. DEN240045Teal Wand
  446. DEN240047Allix5
  447. DEN240048Spur Peripheral Retrievable Stent System
  448. DEN240062Minder System
  449. DEN240064CT-132
  450. DEN240066COAPTIUM Connect with TISSIUM LIGHT
  451. DEN240067KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
  452. DEN240068ArteraAI Prostate
  453. DEN240071neuropacs
  454. DEN240073PainChek (PainChek Adult)
  455. DEN240074Pulsenmore ES
  456. DEN240075Prolystica Pass Thru Disinfectant Wipes
  457. DEN240076Modius Lean
  458. DEN240077MuReva OM™
  459. DEN240080Biolinq Shine Autonomous Time-in-Range Microsensor
  460. DEN250002Delphi-MD System
  461. DEN250004QIKCAP System
  462. DEN250005Sana Device
  463. DEN250006Amferia Wound Dressing
  464. DEN250007Delivery Date AI
  465. DEN250009VitaSmart Hypothermic Oxygenated Perfusion System
  466. DEN250012LifeVac
  467. DEN250013Modius Spero
  468. DEN250014Tyto Insights for Eardrum Bulging Detection
  469. DEN250015Neurolyser XR (NXR100)
  470. DEN250016Essilor® Stellest®
  471. DEN250023Aurie System
  472. DEN250025Syncron-E
  473. DEN250026Avulux
  474. DEN250028DeepView AI® System
  475. DEN250032LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
  476. DEN250033XplantR Explant Tool
  477. DEN250034Claria System
  478. DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
  479. DEN250040SportSuite Vision Software
  480. DEN250042CaRi-Heart
  481. DEN250043Qoramatic Automated Stool Management
  482. DEN250044STEMI AI ECG Model
  483. DEN250046Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
  484. DEN250049Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
  485. DEN250057PCWP Analysis Software
  486. DEN250067ReneuRx™ (Neural Ice)
  487. DEN250068OTTAVA™ Robotic Surgical System
  488. DEN260007SmartRead(TM) Medical Device Identifier (4100)
  489. DEN980001DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND
  490. DEN980003DIAMOND PROBE/PERIO 2000 SYSTEM
  491. DEN990002KAVO DIAGNODENT
  492. DEN990005THE 3PM EGG MACHINE
  493. DEN990008WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

About this dataset

The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.

Source: U.S. Food and Drug Administration (FDA), De Novo database