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
28657–28680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2017
CRESCENT™ Spinal System
K171031 · MAX
Medtronic Sofamor Danek
Orthopedic · 91d
Cleared CT Jul 06, 2017
Philips BlueControl
K171055 · ONE
Philips Electronics Nederland B.V.
General & Plastic Surgery · 87d
Cleared Jul 06, 2017
Dermal Cooling System
K171398 · GEH
R2 Dermatology ,Inc
General & Plastic Surgery · 55d
Cleared Jul 06, 2017
MPR2 logO DATALOGGER
K171666 · GWM
Raumedic AG
Neurology · 31d
Cleared Jul 05, 2017
Leica FL560
K170239 · IZI
Leica Microsystems (Schweiz) AG
Radiology · 160d
Cleared Jul 05, 2017
TOKUYAMA CUREGRACE
K170549 · EBI
Tokuyama Dental Corporation
Dental · 131d
Cleared Jul 05, 2017
Eclipse Treatment Planning System
K170969 · MUJ
Varian Medical Systems, Inc.
Radiology · 96d
Cleared Jul 05, 2017
g.Nautilus PRO
K171669 · GWL
G.Tec Medical Engineering GmbH
Neurology · 30d
Cleared Jul 03, 2017
Enterprise Imaging XERO Viewer 8.1
K170434 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Jul 03, 2017
Equashield Closed System drug Transfer Device (CSTD)
K170706 · ONB
Equashield Medical , Ltd.
General Hospital · 117d
Cleared Jul 03, 2017
Gemini-C Hybrid Cervical Interbody System
K170844 · ODP
Osseus Fusion Systems, LLC
Orthopedic · 104d
Cleared Jul 03, 2017
DigniCap Scalp Cooling System
K170871 · PMC
Dignitana AB
General & Plastic Surgery · 102d
Cleared Jul 03, 2017
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K170955 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 94d
Cleared Jul 03, 2017
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical...
K170974 · OYE
Becton, Dickinson and Company
Immunology · 91d
Cleared Jul 03, 2017
NavLock Trackers
K171267 · OLO
Medtronic Navigation
Orthopedic · 63d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Jul 01, 2017
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
K171613 · MOF
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jun 30, 2017
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy...
K160553 · HRS
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 487d
Cleared Jun 30, 2017
NextDent Denture, E-Denture
K162572 · EBI
Vertex-Dental B.V.
Dental · 288d
Cleared Jun 30, 2017
iVitri EZ
K162640 · MQK
Reprobitech Corp.
Obstetrics & Gynecology · 281d
Cleared Jun 30, 2017
Gelweave Vascular Grafts
K162794 · DSY
Vascutek, Ltd.
Cardiovascular · 269d
Cleared Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console...
K163624 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 190d
Cleared Jun 30, 2017
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
K170177 · JAK
Toshibamedical Systems Corporation
Radiology · 162d
Cleared Jun 30, 2017
GRAVITY™ Syndesmosis LP
K170249 · HTN
Wrightmedicaltechnologyinc
Orthopedic · 154d