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
20401–20424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2020
Patient Monitor
K192514 · MHX
Edan Instruments, Inc.
Cardiovascular · 203d
Cleared Apr 02, 2020
SYMPHONY™ OCT System
K192646 · NKG
Medos International SARL
Orthopedic · 191d
Cleared Apr 02, 2020
TwitchView System
K192958 · KOI
Blink Device Company
Anesthesiology · 163d
Cleared Apr 02, 2020
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal...
K193027 · BZT
Deroyal Industries, Inc.
Anesthesiology · 155d
Cleared Apr 02, 2020
Ambu aScope 4 Cysto
K193095 · FAJ
Ambu A/S
Gastroenterology & Urology · 147d
Cleared CT Apr 02, 2020
NovaCross CTO Microcatheter
K193322 · DQY
Nitiloop , Ltd.
Cardiovascular · 122d
Cleared Apr 02, 2020
CS Model+
K193390 · PNN
Trophy
Dental · 118d
Cleared Apr 02, 2020
ARC 400
K193591 · GEI
Bowa-Electronics GmbH & Co. KG
General & Plastic Surgery · 101d
Cleared Apr 02, 2020
FilmArray BCID2 Control Panel M416
K200010 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 91d
Cleared Apr 02, 2020
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
K200251 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Apr 02, 2020
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin...
K200319 · FMT
Deroyal Industries, Inc.
General Hospital · 55d
Cleared Apr 02, 2020
EVOS Lumbar Interbody System
K200552 · MAX
Cutting Edge Spine, LLC
Orthopedic · 30d
Cleared Apr 02, 2020
FIREBIRD SI Fusion System
K200696 · OUR
Orthofix, Inc.
Orthopedic · 16d
Cleared Apr 01, 2020
Venus VivaTM
K191065 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 345d
Cleared Apr 01, 2020
Magnetic Surgical System
K191762 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 275d
Cleared Apr 01, 2020
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical...
K192228 · PSW
Cs Medical, LLC
General Hospital · 229d
Cleared Apr 01, 2020
Manual Wheelchair
K192658 · IOR
Jerry Medical Instrument (Shanghai)...
Physical Medicine · 189d
Cleared Apr 01, 2020
Introcan Safety 2 IV Catheter 18-24 gauge
K192676 · FOZ
B.Braun Medical, Inc.
General Hospital · 188d
Cleared Apr 01, 2020
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove...
K192988 · KGO
Medline Industries, Inc.
General Hospital · 159d
Cleared Apr 01, 2020
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer...
K193580 · ONN
Orthosensor, Inc.
Orthopedic · 100d
Cleared Apr 01, 2020
LOGIQ E10s
K200119 · IYN
GE Medical Systems Ultrasound and...
Radiology · 71d
Cleared Apr 01, 2020
DSI Dental Implant System
K200188 · DZE
Dsi Dental Solutions, Ltd.
Dental · 68d
Cleared Apr 01, 2020
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All,...
K200524 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Apr 01, 2020
Focus 43C detector, TRIMAX 43C detector
K200622 · MQB
Iray Technology Taicang , Ltd.
Radiology · 23d