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
18625–18648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2020
DePuy Corail AMT Hip Prosthesis
K203167 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Nov 18, 2020
Liebel-Flarsheim IBP Transfer Set
K193010 · PQH
Liebel-Flarsheim Company, LLC
General Hospital · 386d
Cleared Nov 18, 2020
Viveve System
K200472 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 266d
Cleared Nov 18, 2020
Freedom(R) - TiNbN Coated Knee
K200912 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 226d
Cleared Nov 18, 2020
Genius AI Detection
K201019 · QDQ
Hologic, Inc.
Radiology · 215d
Cleared Nov 18, 2020
syngo.via MI Workflows, syngo MBF
K201195 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared Nov 18, 2020
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy...
K201382 · OAS
De Gotzen S.R.L.
Radiology · 176d
Cleared Nov 18, 2020
GlidePath 7.5F Long-Term Dialysis Catheter
K202150 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 107d
Cleared Nov 18, 2020
Venue Go
K202233 · IYN
GE Medical Systems Ultrasound and...
Radiology · 103d
Cleared Nov 18, 2020
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with...
K202449 · KGO
Medline Industries, Inc.
General Hospital · 84d
Cleared Nov 18, 2020
Chrome
K202503 · GEX
Quanta System Spa
General & Plastic Surgery · 79d
Cleared Nov 18, 2020
Arthrex FastThread Interference Screw
K202535 · MAI
Arthrex, Inc.
Orthopedic · 78d
Cleared Nov 18, 2020
TrueView 100 Pro
K202713 · MWP
Compai Healthcare (Shenzhen) Co.,Ltd
Radiology · 63d
Cleared Nov 18, 2020
Pacific Plus PTA Catheter
K202800 · LIT
Medtronic Vascular,Inc(Formerly D.B.A...
Cardiovascular · 56d
Cleared Nov 18, 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · QEW
Penumbra, Inc.
Cardiovascular · 55d
Cleared Nov 18, 2020
FIREBIRD SI Fusion System
K203138 · OUR
Orthofix, Inc.
Orthopedic · 29d
Cleared Nov 18, 2020
HiRise
K203187 · JAK
Curvebeam, LLC
Radiology · 22d
Cleared Nov 18, 2020
DBSWIN, VISTAEASY
K203287 · LLZ
D?rr Dental SE
Radiology · 9d
Cleared Nov 17, 2020
PROView
K193306 · LLZ
GE Medical Systems SCS
Radiology · 354d
Cleared Nov 17, 2020
R501 aortic root cannula without vent line, R502 aortic root cannula with...
K200612 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 253d
Cleared Nov 17, 2020
S.I.N. Dental Implant System
K200992 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 216d
Cleared Nov 17, 2020
JETi AIO Peripheral Thrombectomy System
K201998 · QEZ
Walk Vascular, LLC
Cardiovascular · 120d
Cleared Nov 17, 2020
Activ Fuse
K202307 · HRS
Newclip Technics
Orthopedic · 95d
Cleared Nov 17, 2020
Knotless TensionTight Button Implant System
K202444 · MBI
Arthrex, Inc.
Orthopedic · 83d