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
18601–18624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2020
Vscan Air
K202035 · ITX
GE Medical Systems Ultrasound and...
Radiology · 120d
Cleared Nov 20, 2020
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Nov 20, 2020
Medical surgical mask
K202139 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 112d
Cleared Nov 20, 2020
FilmArray Global Fever Panel External Control Kit
K202382 · PMN
Biofire Defense, LLC
Microbiology · 92d
Cleared Nov 20, 2020
LC ResinCal PC
K202413 · EJK
S&C Polymer Silicon- Und Composite...
Dental · 88d
Cleared Nov 20, 2020
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device...
K202529 · LRK
Prosomnus Sleep Technologies, Inc.
Dental · 80d
Cleared Nov 20, 2020
Ortho Solutions Plating System
K202764 · HRS
Ortho Solutions UK , Ltd.
Orthopedic · 60d
Cleared Nov 20, 2020
Optimized Positioning System (OPS) Insight
K202805 · LLZ
Corin USA
Radiology · 58d
Cleared Nov 20, 2020
Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation...
K202962 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 51d
Cleared Nov 20, 2020
Arthrex Eclipse Titanium Humeral Head
K203100 · PKC
Arthrex, Inc.
Orthopedic · 37d
Cleared Nov 20, 2020
DTX Studio Clinic
K203156 · LLZ
Nobel Biocare AB
Radiology · 29d
Cleared Nov 20, 2020
Revolution Ascend
K203169 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Nov 20, 2020
Fortress Introducer Sheath System
K203179 · DYB
Contract Medical International, GmbH
Cardiovascular · 25d
Cleared Nov 19, 2020
GM501 Wash with Phenol Red and Gentamicin
K192503 · MQL
Hamilton Thorne Incorporated
Obstetrics & Gynecology · 434d
Cleared Nov 19, 2020
Sapphire Infusion Pump, Sapphire administration sets
K192860 · FRN
Q Core Medical , Ltd.
General Hospital · 412d
Cleared Nov 19, 2020
SMR TT Augmented Glenoid System
K200171 · PHX
Lima Corporate S.P.A.
Orthopedic · 301d
Cleared Nov 19, 2020
FotoDent denture
K200580 · EBI
Dreve Dentamid GmbH
Dental · 259d
Cleared Nov 19, 2020
K2 MOBILE
K200693 · GEX
Hulaser, Inc.
General & Plastic Surgery · 248d
Cleared Nov 19, 2020
Air Compression Therapy Device
K201694 · IRP
Shenzhen Dongjilian Electronics Co.,...
Physical Medicine · 150d
Cleared Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...
K201867 · FKX
Baxter Healthcare Corporation
Gastroenterology & Urology · 135d
Cleared Nov 19, 2020
StarWalker
K202172 · GEX
Fotona D.O.O.
General & Plastic Surgery · 108d
Cleared Nov 19, 2020
Carewear Firefly Wrinkle Reduction
K202442 · OHS
Carewear Corp.
General & Plastic Surgery · 85d
Cleared Nov 19, 2020
Laser Therapy Device
K202980 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 50d
Cleared Nov 19, 2020
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
K203008 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 49d