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
21505–21528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2019
Engage™ Partial Knee System
K190439 · NJD
Engage Uni, LLC
Orthopedic · 269d
Cleared Nov 21, 2019
Asahi PTCA Guide Wire Asahi SION Series
K191464 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 171d
Cleared Nov 21, 2019
SAM IO Intraosseous Access System
K191488 · FMI
Sam? Medical Products, Inc.
General Hospital · 170d
Cleared Nov 21, 2019
SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open...
K192061 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Nov 21, 2019
Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
K192124 · GEI
Us Medical Innovations, LLC
General & Plastic Surgery · 107d
Cleared Nov 21, 2019
M. Blue Adjustable Shunt System
K192266 · JXG
Aesculap, Inc.
Neurology · 92d
Cleared Nov 21, 2019
LZI Cotinine II Enzyme Immunoassay
K192299 · MKU
Lin-Zhi International, Inc.
Toxicology · 90d
Cleared Nov 21, 2019
Torpedo Gelatin Foam
K192480 · KRD
Biosphere Medical, S.A.
Cardiovascular · 72d
Cleared Nov 21, 2019
Axis Plating System
K192592 · HRS
Extremity Medical, LLC
Orthopedic · 62d
Cleared Nov 21, 2019
PG Pro Microcatheter
K192625 · DQY
MicroVention, Inc. A TERUMO Group...
Cardiovascular · 59d
Cleared Nov 21, 2019
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
K192996 · DQY
Biotronik, Inc.
Cardiovascular · 24d
Cleared Nov 20, 2019
SDS1.2 dental implant
K181953 · DZE
Sds Swiss Dental Solutions AG
Dental · 485d
Cleared Nov 20, 2019
Ziehm 8000
K190497 · OWB
Ziehm Imaging GmbH
Radiology · 265d
Cleared Nov 20, 2019
SmartLite Pro Modular LED Curing Light
K191865 · EBZ
Dentsply Sirona
Dental · 131d
Cleared Nov 20, 2019
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior...
K192281 · MRW
Medos International SARL
Orthopedic · 90d
Cleared Nov 20, 2019
FUJIFILM Endoscope Model EC-760Z-V/L
K192664 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 56d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Shanghai United Imaging Healthcare...
Radiology · 55d
Cleared Nov 20, 2019
TranS1 AxiaLIF Plus System
K192792 · KWQ
Trans1
Orthopedic · 51d
Cleared Nov 20, 2019
Penumbra LP Coil System
K192955 · HCG
Penumbra, Inc.
Neurology · 30d
Cleared Nov 19, 2019
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550,...
K182979 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 389d
Cleared Nov 19, 2019
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K190816 · LHI
Avenir Performance Europeenne Medical...
General Hospital · 235d
Cleared Nov 19, 2019
RSI-MRI+
K191278 · LLZ
Multimodal Imaging Services...
Radiology · 190d
Cleared Nov 19, 2019
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal...
K192204 · NUC
Valencia Naturals, Inc.
Obstetrics & Gynecology · 97d
Cleared Nov 19, 2019
TwinScan 808/755 Laser System
K192269 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 90d