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
3361–3384 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2017
Exofin Fusion Skin Closure System
K171442 · OMD
Chemence Medical, Inc.
General & Plastic Surgery · 132d
Cleared Sep 22, 2017
SERI Contour
K172545 · OXF
Sofregen Medical, Inc.
General & Plastic Surgery · 30d
Cleared Sep 22, 2017
Sterling Supreme Diode Laser
K171986 · GEX
CAO Group, Inc.
General & Plastic Surgery · 81d
Cleared Sep 22, 2017
Occlusion Detection Dressing Kit
K171499 · OMP
Cardinalhealth
General & Plastic Surgery · 122d
Cleared Sep 22, 2017
TempSure
K171262 · GEI
Cynosure, Inc.
General & Plastic Surgery · 144d
Cleared Sep 22, 2017
Thermage FLX System and Accessories
K170758 · GEI
Solta Medical
General & Plastic Surgery · 193d
Cleared Sep 21, 2017
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9%...
K172486 · FRO
Anexa Biomedical, Inc.
General & Plastic Surgery · 35d
Cleared Sep 21, 2017
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist...
K170879 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 181d
Cleared Sep 21, 2017
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
K170641 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 203d
Cleared Sep 20, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 30d
Cleared Sep 19, 2017
da Vinci Xi Surgical System
K171632 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 109d
Cleared Sep 18, 2017
LightSheer Desire
K170179 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 242d
Cleared Sep 18, 2017
Winback Back 3SE
K162828 · PBX
Winback USA Corp
General & Plastic Surgery · 346d
Cleared Sep 15, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172519 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 25d
Cleared Sep 14, 2017
IntelliCart System
K172481 · JCX
Dornoch Medical Systems
General & Plastic Surgery · 29d
Cleared Sep 14, 2017
Amsel Occluder Device
K172479 · FZP
Amsel Medical
General & Plastic Surgery · 29d
Cleared Sep 13, 2017
Pollogen Legend+ System
K171359 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 127d
Cleared Sep 12, 2017
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site...
K170875 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 172d
Cleared Sep 12, 2017
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
K170409 · GEX
Topcon Medical Laser Systems, Inc....
General & Plastic Surgery · 214d
Cleared Sep 11, 2017
da Vinci Xi EndoWrist Instruments and Accessories
K170645 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 193d
Cleared Sep 11, 2017
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved...
K170644 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 193d
Cleared Sep 08, 2017
BM.IRIS
K171648 · GEX
Bluecore Co., Ltd.
General & Plastic Surgery · 95d
Cleared Sep 07, 2017
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
K170381 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 212d
Cleared Sep 01, 2017
Emprint SX Ablation Platform and Accessories
K171358 · NEY
Coviden, LLC
General & Plastic Surgery · 115d