FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,288 results
3817–3840 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2016
IPL Therapy Machine
K161286 · ONF
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 87d
Cleared Aug 04, 2016
Microlyte Ag
K153756 · FRO
Imbed Biosciences, Inc.
General & Plastic Surgery · 218d
Cleared Aug 04, 2016
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,...
K153209 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 273d
Cleared Aug 03, 2016
DURAFIBER Ag
K161289 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 86d
Cleared Aug 01, 2016
EndyMed Contour Handpiece
K161199 · PBX
Endymed Medical, Ltd.
General & Plastic Surgery · 95d
Cleared Jul 29, 2016
Bright
K161849 · OHS
Tanda Beauty Canada, Inc.
General & Plastic Surgery · 24d
Cleared Jul 29, 2016
Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating,...
K161558 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 53d
Cleared Jul 28, 2016
Medilas H Laser Fibers
K161771 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 30d
Cleared Jul 28, 2016
Waterlase Express
K161669 · GEX
Biolase, Inc.
General & Plastic Surgery · 42d
Cleared Jul 28, 2016
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
K161020 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 107d
Cleared Jul 28, 2016
Atteris Antimicrobial Skin & Wound Cleanser
K160192 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 183d
Cleared Jul 26, 2016
VITRUVIAN ULTIMATE ASPIRATOR
K161722 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 34d
Cleared Jul 26, 2016
truFreeze System
K161557 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 50d
Cleared Jul 26, 2016
Atteris No-Sting Skin Protectant
K160684 · KMF
Rochal Industries, LLC
General & Plastic Surgery · 137d
Cleared Jul 26, 2016
DuraLazeTM HoLEP Laser Fiber
K153124 · GEX
Medkey, LLC
General & Plastic Surgery · 271d
Cleared Jul 21, 2016
SculpSure
K160470 · PKT
Cynosure, Inc.
General & Plastic Surgery · 153d
Cleared Jul 21, 2016
INTRAcel Premium Fractional RF Micro Needle (FRM) System
K153727 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 206d
Cleared Jul 21, 2016
Dakin's Skin and Wound Cleanser
K150208 · FRO
Century Pharmaceuticals, Inc.
General & Plastic Surgery · 538d
Cleared Jul 20, 2016
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved...
K161137 · GDW
Cardica, Inc.
General & Plastic Surgery · 89d
Cleared Jul 20, 2016
OsteoFab Patient Specific Facial Device
K161052 · KKY
Oxford Performance Materials, Inc.
General & Plastic Surgery · 97d
Cleared Jul 20, 2016
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
K160333 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 163d
Cleared Jul 20, 2016
XP1100 RF
K152731 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 302d
Cleared Jul 14, 2016
Biopor, AOC Porous Polyethylene, Cerepor
K160988 · KKY
Ceremed , Inc.
General & Plastic Surgery · 97d
Cleared Jul 14, 2016
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR...
K153087 · GAT
Ivy Sports Medicine, LLC
General & Plastic Surgery · 262d