FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25153–25176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2018
OSCAR (OSCAR Prime, OSCAR Classic)
K181943 · OWB
Genoray Co., Ltd.
Radiology · 28d
Cleared Aug 17, 2018
SmartPerfusion
K181966 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 25d
Cleared Aug 17, 2018
PreXion 3D Excelsior
K181983 · OAS
Prexion Corporation
Radiology · 23d
Cleared Aug 16, 2018
Multi-parameter Patient Monitor, models C30
K173454 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 283d
Cleared Aug 16, 2018
NeuroQ 3.8
K180077 · KPS
Syntermed
Radiology · 218d
Cleared Aug 16, 2018
IGTFusion
K180522 · LLZ
Igi Technologies
Radiology · 170d
Cleared CT Aug 16, 2018
Bongo
K180619 · OHP
Innomed Healthscience, Inc.
Ear, Nose, Throat · 160d
Cleared Aug 16, 2018
Cytosponge Cell Collection Device
K181020 · EOX
Covidien, LLC
Gastroenterology & Urology · 121d
Cleared Aug 16, 2018
GentleCath Glide Intermittent Urinary Catheter
K181206 · GBM
Convatec Limited
Gastroenterology & Urology · 101d
Cleared Aug 16, 2018
Luminelle DTx Hysteroscopy System
K181909 · FAJ
Uvision360, Inc.
Obstetrics & Gynecology · 30d
Cleared CT Aug 15, 2018
Sonata Sonography-Guided Transcervical Fibroid Ablation System
K173703 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 254d
Cleared Aug 15, 2018
Stat Profile Prime Plus Analyzer System
K180428 · JGS
Nova Biomedical Corporation
Chemistry · 180d
Cleared Aug 15, 2018
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K181289 · OCC
Cepheid
Microbiology · 91d
Cleared Aug 15, 2018
SuperGrow 272, Ultimate 272
K181308 · OAP
Super Grow Lasers
General & Plastic Surgery · 90d
Cleared Aug 15, 2018
Aries® Lumbar Interbodies
K181347 · MAX
Osseus Fusion Systems, LLC
Orthopedic · 86d
Cleared Aug 15, 2018
InterActive SMARTBase Abutments
K181359 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 85d
Cleared Aug 15, 2018
Artis zee/zeego & Artis Q/Q.zen
K181407 · OWB
Siemens Medical Solution USA, Inc.
Radiology · 77d
Cleared Aug 15, 2018
BRILLIANT Crios
K181500 · EBF
Coltene/Whaledent AG
Dental · 69d
Cleared Aug 15, 2018
RAIN Sheath Transradial
K181592 · DYB
Cordis Corporation
Cardiovascular · 58d
Cleared Aug 15, 2018
Mini Ridge Filter and auxiliary functions for PROBEAT-V
K181676 · LHN
Hitachi Ltd. Healthcare Hitachi Works
Radiology · 51d
Cleared Aug 15, 2018
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K181711 · PMN
Microbiologics, Inc.
Microbiology · 48d
Cleared Aug 14, 2018
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K173620 · OBP
Tonica Elektronik A/S
Neurology · 265d
Cleared Aug 14, 2018
Vicks RapidRead Digital Thermometer
K180131 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 209d
Cleared Aug 14, 2018
uCT 530, uCT 550
K181414 · JAK
Shanghai United Imaging Healthcare...
Radiology · 76d