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
2521–2544 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2020
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
K192951 · GEX
Ellipse A/S
General & Plastic Surgery · 157d
Cleared Mar 26, 2020
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
K191749 · OWT
Novus Scientific AB
General & Plastic Surgery · 269d
Cleared Mar 25, 2020
TempSure System
K200241 · PBX
Cynosure, LLC
General & Plastic Surgery · 54d
Cleared Mar 25, 2020
Shapiro MD model laser 272
K193667 · OAP
Conversion Labs, Pr, LLC
General & Plastic Surgery · 85d
Cleared Mar 25, 2020
LightWalker Laser System Family
K193661 · GEX
Fotona D.O.O.
General & Plastic Surgery · 86d
Cleared Mar 25, 2020
Cry-Ac®, Cry-Ac-3®, Cry-Baby
K193619 · GEH
Brymill Cryogenic Systems
General & Plastic Surgery · 90d
Cleared Mar 25, 2020
IPL + Diode Laser Machine
K193328 · ONF
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 114d
Cleared Mar 25, 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · NEW
Ethicon, Inc.
General & Plastic Surgery · 230d
Cleared Mar 24, 2020
PlasmaBlade X 3.0S LIGHT
K193579 · GEI
Medtronic Navigation
General & Plastic Surgery · 92d
Cleared Mar 24, 2020
Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
K193145 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 132d
Cleared Mar 20, 2020
Q Switched Nd: YAG Laser machine
K193609 · GEX
Beijing Lead Beauty S & T Co., Ltd.
General & Plastic Surgery · 85d
Cleared Mar 20, 2020
EnlightenVue Microendoscopy System
K192300 · GCJ
Enlightenvue, Inc.
General & Plastic Surgery · 210d
Cleared Mar 20, 2020
Encision AEM Monopolar Laparoscopic Instruments and Accessories
K191612 · GEI
Encision Incorporated
General & Plastic Surgery · 277d
Cleared Mar 19, 2020
Deklene MAXX
K193530 · GAW
Teleflex Medical
General & Plastic Surgery · 90d
Cleared Mar 17, 2020
Wolf445nm
K192272 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 208d
Cleared Mar 16, 2020
SANDRO Dual
K200110 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 59d
Cleared Mar 16, 2020
Epic 980
K193486 · GEX
Biolase, Inc.
General & Plastic Surgery · 90d
Cleared Mar 13, 2020
GIA Stapler with Tri-Staple Technology
K192720 · GDW
Covidien
General & Plastic Surgery · 168d
Cleared Mar 13, 2020
MeDioStar
K192483 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 185d
Cleared Mar 12, 2020
elysion-pro
K193367 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 99d
Cleared Mar 11, 2020
AC5 Topical Gel
K190129 · FRO
Arch Therapeutics, Inc.
General & Plastic Surgery · 408d
Cleared Mar 10, 2020
Rapid Acoustic Pulse Device
K200331 · GEX
Soliton, Inc.
General & Plastic Surgery · 29d
Cleared Mar 10, 2020
Bare: 808
K193446 · GEX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Mar 09, 2020
Senhance Surgical System
K200049 · NAY
Transenterix, Inc.
General & Plastic Surgery · 60d