Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
33865–33888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2015
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
K152550 · DSI
Medicalgorithmics S.A.
Cardiovascular · 30d
Cleared Oct 08, 2015
ULTRASOUND SYSTEM SONIMAGE HS 1
K152577 · IYN
Konica Minolta, Inc.
Radiology · 29d
Cleared Oct 08, 2015
Medilas H RFID Laser Fibers
K152591 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 28d
Cleared Oct 07, 2015
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam...
K151261 · OMP
Medela AG
General & Plastic Surgery · 148d
Cleared Oct 07, 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
K151375 · NHA
Prismatik Dentalcraft, Inc.
Dental · 138d
Cleared Oct 07, 2015
Etest Ceftaroline (0.002 - 32ug/ml)
K151873 · JWY
Biomerieux S.A.
Microbiology · 90d
Cleared Oct 07, 2015
DEXIS Webview
K151941 · LLZ
Imaging Sciences International...
Radiology · 85d
Cleared Oct 06, 2015
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR...
K150209 · MAI
Depuy Mitek, A Johnson and Johnson...
Orthopedic · 249d
Cleared Oct 06, 2015
NuBrilliance Light Pain Therapy
K150554 · ILY
Wellquest International, Inc.
Physical Medicine · 216d
Cleared Oct 06, 2015
Physica CR Knee System
K151266 · JWH
Lima Corporate S.P.A.
Orthopedic · 146d
Cleared Oct 06, 2015
Inion Spinal Graft Containment System
K151360 · OJB
Inion OY
Orthopedic · 139d
Cleared Oct 06, 2015
Arcos One-piece Femoral Revision System
K151603 · LPH
Biomet, Inc.
Orthopedic · 116d
Cleared Oct 06, 2015
Comet Pressure Guidewire
K151610 · DXO
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Oct 06, 2015
iLab Polaris Multi-Modality Guidance System
K151613 · DQK
Boston Scientific Corporation
Cardiovascular · 113d
Cleared CT Oct 06, 2015
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay...
K151906 · PGI
Luminex Corporation
Microbiology · 85d
Cleared Oct 06, 2015
ARIES System
K151917 · OOI
Luminex Corporation
Chemistry · 85d
Cleared Oct 06, 2015
ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
K152369 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 46d
Cleared Oct 06, 2015
AXIOS Stent and Delivery System
K152572 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Oct 05, 2015
ADX6000 Portable X-Ray System
K143494 · IZL
Dexcowin Co., Ltd.
Radiology · 300d
Cleared Oct 05, 2015
CygneX I System
K143560 · IYE
Accuthera, Inc.
Radiology · 293d
Cleared Oct 05, 2015
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
K151500 · KWS
Custom Orthopaedic Solutions
Orthopedic · 123d
Cleared Oct 05, 2015
STERISPINE PS
K151747 · NKB
Safe Orthopaedics
Orthopedic · 98d
Cleared Oct 05, 2015
Ultraviolet Sunlamps
K151841 · LEJ
Wolff System Technology Corp.
General & Plastic Surgery · 91d
Cleared Oct 05, 2015
Ultrasound Scanner System BK2300
K151910 · IYN
Bk Medical Aps
Radiology · 84d