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
6961–6984 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2007
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
K063536 · GAM
Tyco Healthcare Group
General & Plastic Surgery · 68d
Cleared Jan 29, 2007
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · FRO
Laboratoires Urgo
General & Plastic Surgery · 152d
Cleared Jan 26, 2007
ATRICURE ABLATION SYSTEM
K063630 · GEI
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jan 26, 2007
ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
K062712 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 137d
Cleared Jan 26, 2007
TISSUE SITE MARKING SYSTEM
K062528 · NEU
Suros Surgical Systems, Inc.
General & Plastic Surgery · 150d
Cleared Jan 26, 2007
EZLASE
K061898 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 207d
Cleared Jan 25, 2007
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
K070071 · GEX
Omniguide, Inc.
General & Plastic Surgery · 17d
Cleared Jan 25, 2007
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
K070010 · QSY
Z-Medica Corporation
General & Plastic Surgery · 22d
Cleared Jan 25, 2007
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
K063834 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 30d
Cleared Jan 25, 2007
DIOMED DELTA 25
K063828 · GEX
Diomed, Ltd.
General & Plastic Surgery · 30d
Cleared Jan 25, 2007
V.A.C. FREEDOM CANISTER, MODEL M6275421
K063590 · OMP
Kci USA, Inc.
General & Plastic Surgery · 55d
Cleared Jan 25, 2007
CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330
K062082 · GEI
Conmed Corporation
General & Plastic Surgery · 188d
Cleared Jan 25, 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · FRO
Molnlycke Health Care
General & Plastic Surgery · 234d
Cleared Jan 24, 2007
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
K063235 · QPB
Cytori Therapeutics, Inc.
General & Plastic Surgery · 91d
Cleared Jan 18, 2007
HAIRMAX LASERCOMB
K060305 · OAP
Lexington International, LLC
General & Plastic Surgery · 346d
Cleared Jan 17, 2007
SEPRAMESH, MODEL 5959-1214
K063739 · FTL
Genzyme Corporation
General & Plastic Surgery · 30d
Cleared Jan 17, 2007
3 SERIES PHOTOTHERAPY CABINET
K063621 · FTC
Daavlin Co.
General & Plastic Surgery · 43d
Cleared Jan 17, 2007
TROCASYS
K063528 · GCJ
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 56d
Cleared Jan 17, 2007
VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
K063396 · GEX
Lasering S.R.L.
General & Plastic Surgery · 69d
Cleared Jan 17, 2007
BEAMAX
K063249 · GEX
Medic Sharplight , Ltd.
General & Plastic Surgery · 83d
Cleared Jan 17, 2007
SOCK IT! ORAL PAIN GEL
K063148 · OLR
Merlin Group Dba Mcmerlin Dental Company
General & Plastic Surgery · 93d
Cleared Jan 17, 2007
BWF-5 MEDICAL LASER SERIES, 810 NM
K062363 · GEX
B&W Tek, Inc.
General & Plastic Surgery · 160d
Cleared Jan 17, 2007
PREMIO
K060465 · MXW
Peters Surgical
General & Plastic Surgery · 329d
Cleared Jan 12, 2007
POWER EXTENDERS MODEL# PEC200, PES200,PES200S
K063746 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 25d