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

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175,820 results
32521–32544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2016
ClearMet
K152051 · EBI
Mycone Dental Supply Co., T/A...
Dental · 243d
Cleared Mar 22, 2016
cryoFORM cryoICE cryoablation probe
K152337 · GEH
AtriCure, Inc.
General & Plastic Surgery · 216d
Cleared Mar 22, 2016
Great Basin Shiga Toxin Direct Test
K152955 · PCH
Great Basin Scientific, Inc.
Microbiology · 167d
Cleared Mar 22, 2016
Ingenia 1.5T and Ingenia 1.5T S R5.2
K153324 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 125d
Cleared Mar 22, 2016
Single Use Aspiration Needle NA-U401SX
K160098 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 63d
Cleared Mar 22, 2016
Z-Span Plate System
K160362 · KWQ
Zavation, LLC
Orthopedic · 42d
Cleared Mar 22, 2016
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter,...
K160521 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 26d
Cleared Mar 21, 2016
Oniris
K150566 · LRK
Sas Oniris
Dental · 381d
Cleared Mar 21, 2016
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
K153019 · GXY
Bio Protech, Inc.
Neurology · 158d
Cleared Mar 21, 2016
Powder Free Polychloroprene Examination Glove Green
K153510 · LZA
Terang Nusa Sdn Bhd
General Hospital · 105d
Cleared Mar 21, 2016
Genesis Low Temperature Reusable Rigid Container System
K153554 · KCT
Carefusion 2200, Inc.
General Hospital · 98d
Cleared Mar 21, 2016
Venus Versa System
K153717 · ONF
Venus Concept , Ltd.
General & Plastic Surgery · 88d
Cleared Mar 21, 2016
OS2(R)-VP Varisation Staple
K153770 · JDR
In2bones Sas
Orthopedic · 82d
Cleared Mar 21, 2016
D-SPECT Processing and Reviewing Workstation
K160120 · KPS
Spectrum Dynamics , Ltd.
Radiology · 62d
Cleared Mar 21, 2016
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip...
K160229 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 49d
Cleared Mar 21, 2016
SpeqT
K160420 · IYO
Signostics Limited
Radiology · 34d
Cleared Mar 18, 2016
OVA1 Next Generation
K150588 · ONX
Vermillion, Inc.
Immunology · 375d
Cleared Mar 18, 2016
SPINAUT-P
K150915 · GEI
Imedicom Co., Ltd.
General & Plastic Surgery · 347d
Cleared Mar 18, 2016
AUDICOR CA300/CC100 Analyzer with SDB
K151433 · MNR
Inovise Medical, Inc.
Anesthesiology · 295d
Cleared Mar 18, 2016
CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless...
K151499 · DXN
Caretaker Medical, LLC
Cardiovascular · 288d
Cleared Mar 18, 2016
Slim UP ULTRA
K151722 · NGX
Aime Medical, Inc.
Physical Medicine · 267d
Cleared Mar 18, 2016
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with...
K151749 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 263d
Cleared Mar 18, 2016
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · MPO
CooperSurgical, Inc.
Physical Medicine · 255d
Cleared Mar 18, 2016
DBB-06 Hemodialysis Delivery System
K152938 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 165d