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
3649–3672 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2016
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel...
K162721 · NRB
Alliqua Biomedical, Inc.
General & Plastic Surgery · 84d
Cleared Dec 22, 2016
derma+flex QS High Viscosity Tissue Adhesive
K162352 · MPN
Chemence Medical, Inc.
General & Plastic Surgery · 121d
Cleared Dec 22, 2016
DynaMesh-VENTRAL
K161550 · FTL
Feg Textiltechnik Forschungs- Und...
General & Plastic Surgery · 202d
Cleared Dec 21, 2016
IntelliCartTM System
K162421 · JCX
Dornoch Medical Systems
General & Plastic Surgery · 113d
Not Cleared Dec 21, 2016
AeroForm Tissue Expander System
DEN150055 · PQN
Airxpanders, Inc.
General & Plastic Surgery · 380d
Cleared Dec 20, 2016
Endoform Plastics and Reconstructive Matrix
K162461 · FTM
Aroa Biosurgery (Formerly Mesynthes...
General & Plastic Surgery · 109d
Cleared Dec 19, 2016
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
K160854 · GAT
Biomet Manafacturing Corp.
General & Plastic Surgery · 266d
Cleared Dec 16, 2016
Zerona Z6 OTC
K162578 · OLI
Erchonia Corporation
General & Plastic Surgery · 92d
Not Cleared Dec 16, 2016
CleanCisionTM Wound Retraction and Protection System
DEN150038 · PQI
Prescient Surgical
General & Plastic Surgery · 491d
Cleared Dec 15, 2016
Pulsaderm ACE-All Blue
K162371 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 113d
Cleared Dec 15, 2016
PERMATAPE
K162247 · GAT
Medos International SARL
General & Plastic Surgery · 127d
Cleared Dec 12, 2016
PK AIM
K163373 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 11d
Cleared Dec 12, 2016
InMode RF System
K163190 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 28d
Cleared Dec 12, 2016
Photon, Photon Plus
K162114 · GEX
Zolar Technology & Mfg Co., Inc.
General & Plastic Surgery · 136d
Cleared Dec 12, 2016
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal...
K160969 · GDW
Shinemed, LLC
General & Plastic Surgery · 250d
Cleared Dec 09, 2016
truSculpt
K162512 · PBX
Cutera, Inc.
General & Plastic Surgery · 92d
Cleared Dec 09, 2016
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
K160487 · OMP
Kci USA, Inc.
General & Plastic Surgery · 291d
Cleared Dec 08, 2016
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
K161632 · GEX
Bios S.R.L.
General & Plastic Surgery · 178d
Cleared Dec 06, 2016
Emprint Ablation System
K163105 · NEY
Covidien, LLC
General & Plastic Surgery · 29d
Cleared Dec 06, 2016
Talymed Suspension
K160695 · FRO
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 267d
Cleared Dec 05, 2016
Discovery Pico Family
K163222 · GEX
Quanta System Spa
General & Plastic Surgery · 19d
Cleared Dec 05, 2016
Tri-Staple 2.0 Intelligent Cartridge
K163098 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Dec 05, 2016
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear...
K161757 · GDW
Victor Medical Instruments Co., Ltd.
General & Plastic Surgery · 161d
Cleared Dec 01, 2016
CODMAN Integrated Bipolar Cord and Tubing Set
K163106 · GEI
Medos International SARL
General & Plastic Surgery · 24d