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
3961–3984 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2016
cryoFORM cryoICE cryoablation probe
K152337 · GEH
AtriCure, Inc.
General & Plastic Surgery · 216d
Cleared Mar 21, 2016
Venus Versa System
K153717 · ONF
Venus Concept , Ltd.
General & Plastic Surgery · 88d
Cleared Mar 18, 2016
Quanta System Surgical Laser fibers
K160513 · GEX
Quanta System Spa
General & Plastic Surgery · 23d
Cleared Mar 18, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Mar 18, 2016
SPINAUT-P
K150915 · GEI
Imedicom Co., Ltd.
General & Plastic Surgery · 347d
Cleared Mar 17, 2016
Endo Keeper
K152598 · OTJ
Nelis
General & Plastic Surgery · 188d
Cleared Mar 15, 2016
Endoform Reconstructive Template
K153633 · FTM
Aroa Biosurgery Limited (Formerly...
General & Plastic Surgery · 88d
Cleared Mar 15, 2016
PerioLase Nd:YAG Pulsed Dental Laser System
K151763 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 260d
Cleared Mar 14, 2016
MicroMatrix
K153754 · KGN
Acell, Inc.
General & Plastic Surgery · 76d
Cleared Mar 09, 2016
Family of CoolGlide Aesthetic Lasers
K153671 · GEX
Cutera, Inc.
General & Plastic Surgery · 79d
Cleared Mar 09, 2016
da Vinci Single-Site Instrument and Accessories
K152448 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 195d
Cleared Mar 08, 2016
SurgiPure XD Reconstructive Tissue Matrix
K152206 · FTM
Tissue Regenix Group Plc
General & Plastic Surgery · 215d
Cleared Mar 07, 2016
Cobbra RF Tissue Dissector
K160041 · GEI
Elliquence, LLC
General & Plastic Surgery · 59d
Cleared Mar 04, 2016
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
K152421 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 191d
Cleared Mar 04, 2016
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6,...
K152238 · LEJ
Sun Capsule, Inc.
General & Plastic Surgery · 207d
Cleared Mar 04, 2016
HARMONIC HOOK
K151136 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 310d
Cleared Mar 03, 2016
Dunamis Force DFX Tensile Tape
K153746 · GAT
Dunamis, LLC
General & Plastic Surgery · 65d
Cleared Mar 03, 2016
Tenex Health TX System
K153299 · LFL
Tenex Health, Inc.
General & Plastic Surgery · 111d
Cleared Mar 02, 2016
PicoWay Laser System
K153527 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 84d
Cleared Mar 02, 2016
Sentimag System, Sentimark Magnetic Marker Systerm
K153044 · PBY
Endomagnetics Ltd.,
General & Plastic Surgery · 135d
Cleared Mar 01, 2016
VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
K160230 · GCJ
Covidien
General & Plastic Surgery · 29d
Cleared Mar 01, 2016
3400E series
K151905 · LEJ
Heartland Tanning, Inc.
General & Plastic Surgery · 232d
Cleared Feb 29, 2016
Prevena Plus Incision Management System Kit with Peel & Place Dressing,...
K153199 · OMP
Kci USA, Inc.
General & Plastic Surgery · 119d
Cleared Feb 26, 2016
Novilase Laser Therapy System, Model LTS-2
K160392 · GEX
Novian Health, Inc.
General & Plastic Surgery · 15d