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
3601–3624 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2017
ND YAG Q-switch Laser Therapy Machine
K161926 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 224d
Cleared Feb 17, 2017
ExpressBraid Graft Manipulation
K163651 · GAT
Biomet Manufacturing Corp
General & Plastic Surgery · 56d
Cleared Feb 16, 2017
Valleylab FT10 Electrosurgical Platform
K170170 · GEI
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Feb 16, 2017
Laparoscope Lens Shield Device (LENS)
K170103 · GCJ
Medeon Biodesign, Inc.
General & Plastic Surgery · 35d
Cleared Feb 16, 2017
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
K162965 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 115d
Cleared Feb 16, 2017
Miromatrix Biological Mesh TW
K162570 · FTM
Miromatrix Medical, Inc.
General & Plastic Surgery · 154d
Cleared Feb 16, 2017
T-Cuff
K162365 · KCY
Terumobct, Inc.
General & Plastic Surgery · 177d
Cleared Feb 14, 2017
ENSEAL X1 Large Jaw Tissue Sealer
K163548 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 60d
Cleared Feb 14, 2017
ClariFix Device
K162608 · GEH
Arrinex, Inc.
General & Plastic Surgery · 148d
Cleared Feb 13, 2017
KerraCel Ag Gelling Fiber Silver Dressing
K162508 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 158d
Cleared Feb 10, 2017
GORE BIO-A Tissue Reinforcement
K163217 · OXF
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 86d
Cleared Feb 10, 2017
CRYLREX
K161629 · GAM
Sm Eng Co., Ltd.
General & Plastic Surgery · 242d
Cleared Feb 09, 2017
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single...
K162710 · GDW
Tgs Medical Co., Ltd.
General & Plastic Surgery · 134d
Cleared Feb 08, 2017
Handheld Diode Laser for Hair Removal
K163173 · OHT
Liaoning Sidey Optoelectronics...
General & Plastic Surgery · 86d
Cleared Feb 08, 2017
MyNeWT Negative Pressure Wound Therapy System
K161432 · OMP
Stortford Medical, LLC
General & Plastic Surgery · 260d
Cleared Feb 06, 2017
EndoWrist Suction Irrigator
K162973 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 104d
Cleared Feb 03, 2017
CuraSeal Percutaneous Intraluminal Closure System for Anorectal...
K162388 · FTM
Curaseal, Inc.
General & Plastic Surgery · 162d
Cleared Feb 02, 2017
Q-Switched Nd:YAG Laser Therapy Systems
K163123 · GEX
Beijing Sincoheren Science and...
General & Plastic Surgery · 86d
Cleared Feb 01, 2017
Pre-Formed Penile Silicone Block
K162624 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 134d
Cleared Feb 01, 2017
PicoWay Laser System
K162454 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 153d
Cleared Jan 31, 2017
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302,...
K163170 · OAP
Capillus, LLC
General & Plastic Surgery · 78d
Cleared Jan 31, 2017
OsteoCool V-3 RF Ablation System
K161949 · GEI
Baylis Medical Company, Inc.
General & Plastic Surgery · 200d
Cleared Jan 30, 2017
LED Phototherapy Device
K162098 · OLP
Li-Tek Electronic Technology Corporation
General & Plastic Surgery · 185d
Cleared Jan 30, 2017
OBS Electrosurgical Generator (Model: OBS-350A)
K162034 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 192d