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
18889–18912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2020
ARTHROTAP
K201816 · FMF
Accuro Technologies, Inc.
General Hospital · 107d
Cleared Oct 16, 2020
Disposable Vinyl Glove
K202010 · LYZ
Better Health Medical Products Co., Ltd.
General Hospital · 87d
Cleared Oct 16, 2020
Dall-Miles® Cable System
K202016 · JDQ
Howmedica Osteonics Corp., Dba...
Orthopedic · 87d
Cleared Oct 16, 2020
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP...
K202193 · MBI
S.B.M. Sas (Science & Bio Materials)
Orthopedic · 72d
Cleared Oct 16, 2020
Quantum Ventilation Module
K202733 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 16, 2020
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio...
K202737 · IYN
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 15, 2020
xPORT S Lens Fragmentation System
K200207 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d
Cleared Oct 15, 2020
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact...
K200296 · LPL
Pegavision Corporation
Ophthalmic · 252d
Cleared Oct 15, 2020
Arthrosurface WristMotion Total Wrist Arthroplasty System
K200718 · JWJ
Arthrosurface, Inc.
Orthopedic · 210d
Cleared Oct 15, 2020
Foley Catheter with Temperature Sensor
K200757 · EYC
Deroyal Industries, Inc.
Gastroenterology & Urology · 205d
Cleared Oct 15, 2020
STATSTIX
K200764 · MVL
Centrix Incorporated
Dental · 205d
Cleared Oct 15, 2020
SINUSPRIME Dilation System
K201398 · LRC
Stryker Ent
Ear, Nose, Throat · 140d
Cleared Oct 15, 2020
icotec Anterior Cervical Plate System
K201587 · KWQ
Icotec AG
Orthopedic · 126d
Cleared Oct 15, 2020
SIGNA 7.0T
K201615 · LNH
Ge Medical Systems, LLC
Radiology · 122d
Cleared Oct 15, 2020
LIAISON Testosterone xt
K201908 · CDZ
DiaSorin, Inc.
Chemistry · 98d
Cleared Oct 15, 2020
Opera Evo
K202041 · GEX
Quanta System Spa
General & Plastic Surgery · 84d
Cleared Oct 15, 2020
Invictus™ OsseoScrew® System
K202327 · NKB
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Oct 15, 2020
Droplet Pen Needle 30G & 33G
K202340 · FMI
Htl-Strefa S.A
General Hospital · 59d
Cleared Oct 15, 2020
Cartesion Prime, PCD-1000A, V10.7
K202349 · KPS
Canon Medical Systems Corporation
Radiology · 58d
Cleared Oct 15, 2020
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
K202364 · IYN
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 15, 2020
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters,...
K202665 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 31d
Cleared Oct 15, 2020
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
K202680 · HWC
Osteomed, LLC
Orthopedic · 30d
Cleared Oct 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic...
K202683 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 14, 2020
Z5-BL
K200386 · DZE
Z-Systems AG
Dental · 239d