FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
24553–24576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2018
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck...
K180574 · ONB
J & J Solutions, Inc. D/B/A/ Corvida...
General Hospital · 165d
Cleared Aug 17, 2018
Watch-PAT300
K180775 · MNR
Itamar Medical , Ltd.
Anesthesiology · 147d
Cleared Aug 17, 2018
BioWaveGO
K180943 · GZJ
Biowave Corporation
Neurology · 129d
Cleared Aug 17, 2018
CBit Series Digital Color Doppler Ultrasound System
K180974 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 126d
Cleared Aug 17, 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
K181074 · FRO
Simple Science, LLC
General & Plastic Surgery · 115d
Cleared Aug 17, 2018
Actifuse Flow
K181306 · MQV
Baxter Healthcare Corporation
Orthopedic · 92d
Cleared Aug 17, 2018
Ultraxx Nephrostomy Balloon Catheter Set
K181713 · LJE
Cook Incorporated
Gastroenterology & Urology · 50d
Cleared Aug 17, 2018
Cios Select
K181767 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Aug 17, 2018
Quantum Workstation 12.1
K181923 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 30d
Cleared Aug 17, 2018
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
K181940 · OXC
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 29d
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 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 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