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
4009–4032 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2016
ExpressBraid Graft Manipulation
K152868 · GAT
Biomet Manufacturing Corp
General & Plastic Surgery · 131d
Cleared Feb 05, 2016
Stryker CMF MEDPOR Customized Implant
K153508 · FWP
Stryker
General & Plastic Surgery · 60d
Cleared Feb 05, 2016
Cryocare CS Surgical System
K153489 · GEH
Healthtronics
General & Plastic Surgery · 63d
Cleared Feb 05, 2016
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX...
K151185 · FRO
Abl Medical, LLC
General & Plastic Surgery · 277d
Cleared Feb 04, 2016
DermaScalp Laser Cap
K152587 · OAP
Dermascalp, LLC
General & Plastic Surgery · 147d
Cleared Feb 04, 2016
NaturaLase CO2 Laser System
K152529 · GEX
Focus Medical, LLC
General & Plastic Surgery · 154d
Cleared Feb 01, 2016
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic...
K151036 · GCJ
Carefusion 2200, Inc.
General & Plastic Surgery · 287d
Cleared Jan 28, 2016
TACVAC
K153459 · BTA
Athena Gtx
General & Plastic Surgery · 58d
Cleared Jan 28, 2016
PICO Single Use Negative Pressure Wound Therapy System
K151436 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 245d
Cleared Jan 27, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500 · FZP
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jan 27, 2016
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New...
K152233 · LEJ
Sportarredo Group S.C.
General & Plastic Surgery · 173d
Cleared Jan 26, 2016
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue...
K151405 · NLQ
Surgical Instrument Services and...
General & Plastic Surgery · 245d
Cleared Jan 22, 2016
Stryker Neptune E-SEP Smoke Evacuation Pencil
K153679 · GEI
Stryker Corporation
General & Plastic Surgery · 32d
Cleared Jan 22, 2016
Mepiseal Soft Silicone Sealant
K152741 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 121d
Cleared Jan 22, 2016
General & Plastic Surgery Instruments
K152400 · GCJ
Sontec Instruments, Inc.
General & Plastic Surgery · 150d
Cleared Jan 22, 2016
VersaOne Bladed Trocar 5mm
K152149 · GCJ
Covidien
General & Plastic Surgery · 172d
Cleared Jan 21, 2016
AQUACEL Ag Surgical SP Dressing
K152926 · FRO
Convatec Limited
General & Plastic Surgery · 108d
Cleared Jan 20, 2016
PleuraFlow System
K153681 · OTK
Clearflow, Inc.
General & Plastic Surgery · 29d
Cleared Jan 20, 2016
Venus Versa System
K152790 · ONF
Venus Concept , Ltd.
General & Plastic Surgery · 117d
Cleared Jan 20, 2016
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
K152463 · FWP
Poriferous, LLC
General & Plastic Surgery · 145d
Cleared Jan 19, 2016
Capillus202
K153618 · OAP
Capillus, LLC
General & Plastic Surgery · 32d
Cleared Jan 19, 2016
Lustre PRO Light System
K143713 · GEX
Ambicare Health, Ltd.
General & Plastic Surgery · 386d
Cleared Jan 15, 2016
Paragon T2 Wand with Integrated Cable
K153675 · GEI
ArthroCare Corporation
General & Plastic Surgery · 25d
Cleared Jan 15, 2016
Bovie Disposable Bipolar Ablator
K152777 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 112d