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
6337–6360 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2008
VERTEBRAL ACCESS SYSTEM BY VIDACARE
K081713 · MOQ
Vidacare Corporation
General & Plastic Surgery · 157d
Cleared Nov 20, 2008
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
K082284 · JCT
Alveolus, Inc.
General & Plastic Surgery · 101d
Cleared Nov 17, 2008
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
K082568 · GEI
Bovie Medical
General & Plastic Surgery · 74d
Cleared Nov 14, 2008
ULTRAWAVE III EX 1320
K083207 · GEX
Quanta System Spa
General & Plastic Surgery · 14d
Cleared Nov 14, 2008
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
K082322 · GCJ
Covidien
General & Plastic Surgery · 93d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 100d
Cleared Nov 14, 2008
LTM-BPS SURGICAL MESH
K082176 · FTM
Lifecell Corp.
General & Plastic Surgery · 105d
Cleared Nov 14, 2008
TANDA SKINCARE SYSTEM, MODEL: PTSCS
K080591 · GEX
Pharos Life Corporation
General & Plastic Surgery · 256d
Cleared Nov 13, 2008
EZLASE 10W
K083069 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 29d
Cleared Nov 13, 2008
SERISCAFFOLD SURGICAL MESH
K080442 · FTL
Serica Technologies, Inc.
General & Plastic Surgery · 268d
Cleared Nov 12, 2008
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
K083190 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 14d
Cleared Nov 12, 2008
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
K082762 · JCX
Aardvark Medical
General & Plastic Surgery · 51d
Cleared Nov 12, 2008
BENACEL, MODELS C-001, C-002 AND C-005
K080532 · QSY
Unicare Biomedical, Inc.
General & Plastic Surgery · 260d
Cleared Nov 12, 2008
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
K080503 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 261d
Cleared Nov 10, 2008
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
K082876 · GEX
Sharplight Technologies, Ltd.
General & Plastic Surgery · 42d
Cleared Nov 07, 2008
SILS PORT, MODELS SILSPT5, SILSPT12
K082619 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 59d
Cleared Nov 05, 2008
ARTHROCARE ARTHROWANDS
K082980 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Nov 05, 2008
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
K082101 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 103d
Cleared Oct 31, 2008
ARAGON ONESHOT SYSTEM
K081312 · GEI
Aragon Surgical, Inc.
General & Plastic Surgery · 175d
Cleared Oct 30, 2008
CHROMOPHARE E 778 AND E 558
K083066 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 15d
Cleared Oct 30, 2008
TEPHAFLEX ABSORBABLE SUTURE
K082178 · NWJ
Tepha, Inc.
General & Plastic Surgery · 90d
Cleared Oct 30, 2008
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED...
K081724 · KGN
Applied Nutritionals
General & Plastic Surgery · 134d
Cleared Oct 28, 2008
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
K082721 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 41d
Cleared Oct 24, 2008
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
K082263 · GEX
Biolitec, Inc.
General & Plastic Surgery · 77d