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
3313–3336 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2017
PALLAS 308/311 Solid-State UV Laser System
K172639 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 63d
Cleared Nov 03, 2017
Geistlich Wound Matrix
K171842 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 136d
Cleared Nov 02, 2017
Valleylab FX8 Electrosurgical Platform
K172757 · GEI
Covidien, LLC
General & Plastic Surgery · 50d
Cleared Nov 02, 2017
Compound W Nitro-Freeze
K172373 · GEH
Medtech Products, Inc.
General & Plastic Surgery · 87d
Cleared Nov 01, 2017
CoolSculpting System
K172144 · OOK
Zeltiq Aesthetics
General & Plastic Surgery · 107d
Cleared Nov 01, 2017
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · GAQ
Ethicon, Inc.
General & Plastic Surgery · 232d
Cleared Oct 31, 2017
Cianna Medical SAVI Scout Reflector and SAVI Scout System
K171767 · NEU
Cianna Medical, Inc.
General & Plastic Surgery · 139d
Cleared Oct 27, 2017
Cutera enlighten III Laser System
K172077 · GEX
Cutera, Inc.
General & Plastic Surgery · 109d
Cleared Oct 27, 2017
Trocar
K172038 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 114d
Cleared Oct 26, 2017
Rhapsody H-30 Holmium Laser System
K172325 · GEX
Cook Incorporated
General & Plastic Surgery · 86d
Cleared Oct 25, 2017
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope...
K173242 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 19d
Cleared Oct 25, 2017
AtriClip LAA Exclusion System with Preloaded PRO·V Clip
K173031 · FZP
AtriCure, Inc.
General & Plastic Surgery · 27d
Cleared Oct 25, 2017
Colorado Therapeutics Xenograft Implant
K172937 · FTM
Colorado Therapeutics, LLC
General & Plastic Surgery · 29d
Cleared Oct 25, 2017
CleanCision Wound Retraction and Protection System
K172132 · PQI
Prescient Surgical, Inc.
General & Plastic Surgery · 103d
Cleared Oct 23, 2017
gi-4000 Electrosurgical Generator
K172805 · GEI
United States Endoscopy Group, Inc.
General & Plastic Surgery · 35d
Cleared Oct 23, 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · GAM
Aesculap, Inc.
General & Plastic Surgery · 202d
Cleared Oct 20, 2017
NeuroBlate System
K172881 · GEX
Monteris Medical,
General & Plastic Surgery · 29d
Cleared Oct 20, 2017
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non...
K172149 · GAP
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 95d
Cleared Oct 20, 2017
Ultimate Contour, Ultimate Contour Mini
K171052 · PBX
CAO Group, Inc.
General & Plastic Surgery · 193d
Cleared Oct 19, 2017
Discovery Pico, Discovery Pico Plus
K172376 · GEX
Quanta System Spa
General & Plastic Surgery · 73d
Cleared Oct 18, 2017
ANCHOR Tissue Retrieval System
K172940 · GCJ
Conmed Corporation
General & Plastic Surgery · 22d
Cleared Oct 18, 2017
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
K172608 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 48d
Cleared Oct 17, 2017
585
K172198 · GEX
Quanta System Spa
General & Plastic Surgery · 88d
Cleared Oct 17, 2017
X-SURGE
K171752 · GEI
Genicon, Inc.
General & Plastic Surgery · 126d