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
4489–4512 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 125d
Cleared Oct 15, 2014
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · NEW
Ethicon, Inc.
General & Plastic Surgery · 105d
Cleared Oct 15, 2014
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER,...
K140470 · GEX
Oberon GmbH Fiber Technologies
General & Plastic Surgery · 232d
Cleared Oct 15, 2014
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
K134009 · FTC
Medtek Lighting
General & Plastic Surgery · 289d
Cleared Oct 15, 2014
MULTIPULSE HOPLUS
K131987 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 474d
Cleared Oct 10, 2014
AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch...
K142614 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 24d
Cleared Oct 10, 2014
EPIC 10
K140120 · GEX
Biolase, Inc.
General & Plastic Surgery · 267d
Cleared Oct 08, 2014
BNX Fine Needle Aspiration System
K142198 · NEU
Covidien, LLC
General & Plastic Surgery · 58d
Cleared Oct 08, 2014
LONG PULSE ND: YAG LASER SYSTEM
K140249 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 250d
Cleared Oct 06, 2014
LiNA SafeAir Smoke Pencil
K142538 · GEI
Lina Medical Aps
General & Plastic Surgery · 27d
Cleared Oct 06, 2014
DIODE LASER HAIR REMOVAL SYSTEM
K141973 · GEX
Beijing Anchorfree Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Oct 06, 2014
ULTRASHAPE SYSTEM
K141708 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 104d
Cleared Oct 03, 2014
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 119d
Cleared Oct 01, 2014
Barrx RFA Self Sizing Balloon Catheter
K142364 · GEI
Covidien, LLC
General & Plastic Surgery · 37d
Cleared Sep 30, 2014
CLAVEGUARD FREEDOM SURGICAL LIGHT
K142076 · FSY
Dickson & Dickson Healthcare (Us), Inc.
General & Plastic Surgery · 61d
Cleared Sep 29, 2014
Operating Room Light Handle Adapter
K142386 · FTA
Litex Manufacturing, Inc.
General & Plastic Surgery · 33d
Cleared Sep 26, 2014
HEMASORB Resorbable Hemostatic Bone Putty
K142339 · MTJ
Orthocon, LLC
General & Plastic Surgery · 36d
Cleared Sep 26, 2014
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
K141097 · GDW
Touchstone International Medical...
General & Plastic Surgery · 151d
Cleared Sep 26, 2014
SINGLE-SITE WRISTED NEEDLE DRIVER
K141075 · NAY
Intuitive Surgical
General & Plastic Surgery · 154d
Cleared Sep 25, 2014
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
K141358 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 125d
Cleared Sep 25, 2014
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · GAQ
Demetech Corp.
General & Plastic Surgery · 160d
Cleared Sep 25, 2014
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
K140670 · ONF
Ellipse A/S
General & Plastic Surgery · 191d
Cleared Sep 25, 2014
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
K140378 · GEX
Omniguide, Inc.
General & Plastic Surgery · 223d
Cleared Sep 24, 2014
Palomar Icon Aesthetic System
K142376 · GEX
Cynosure, Inc.
General & Plastic Surgery · 29d