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
3673–3696 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2016
Litho
K163009 · GEX
Quanta System Spa
General & Plastic Surgery · 34d
Cleared Dec 01, 2016
Voyant Open Fusion Device
K162676 · GEI
Applied Medical Resources
General & Plastic Surgery · 66d
Cleared Dec 01, 2016
Osseointegrated Fixtures
K161548 · FZE
Southern Implants (Pty), Ltd.
General & Plastic Surgery · 181d
Cleared Dec 01, 2016
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia...
K161128 · OMP
Medela AG
General & Plastic Surgery · 224d
Cleared Dec 01, 2016
WoundPro Negative Pressure Wound Therapy System
K150960 · OMP
Pensar Medical, LLC
General & Plastic Surgery · 601d
Cleared Nov 30, 2016
PleuraFlow System with FlowGlide
K163139 · OTK
Clearflow, Inc.
General & Plastic Surgery · 21d
Cleared Nov 30, 2016
ReliaCatch Specimen Retrieval Bag 10mm
K163102 · GCJ
Covidien
General & Plastic Surgery · 23d
Cleared Nov 30, 2016
ESPADA Acne-Clearing Blue Light Pen
K162450 · OLP
Foreo, Inc.
General & Plastic Surgery · 90d
Cleared Nov 30, 2016
HEMASORBPLUS Resorbable Hemostatic Bone Putty
K153317 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 378d
Cleared Nov 29, 2016
LuminScan (TM) Imaging System
K162466 · NQQ
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 88d
Cleared Nov 29, 2016
InnoSEAL Hemostatic Pad
K161013 · QSY
Innotherapy, Inc.
General & Plastic Surgery · 232d
Cleared Nov 29, 2016
Well Lead Extraction Bag
K160801 · GCJ
Well Lead Medical Co., Ltd.
General & Plastic Surgery · 251d
Cleared Nov 23, 2016
SILK Surgical Suture
K162396 · GAP
Teleflexmedical, Inc.
General & Plastic Surgery · 89d
Cleared Nov 23, 2016
PolyPlex Wound Dressing
K160872 · FRO
Global Health Solutions, LLC
General & Plastic Surgery · 238d
Cleared Nov 23, 2016
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
K160705 · NEW
Y. Jacobs Medical, Inc.
General & Plastic Surgery · 254d
Cleared Nov 22, 2016
NAVILAS Laser System
K162191 · GEX
Od-Os GmbH
General & Plastic Surgery · 110d
Cleared Nov 22, 2016
DW-1C
K160761 · NEW
Dongwon Medical Co., Ltd.
General & Plastic Surgery · 246d
Cleared Nov 22, 2016
Disposal Lens Cleaning Sheath
K153773 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 327d
Cleared Nov 21, 2016
OptiLux LED Illuminator
K163185 · HBI
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Nov 21, 2016
ZELTIQ CoolSculpting System
K162050 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 119d
Cleared Nov 18, 2016
Capillus302, Capillus312, Capillus352
K162994 · OAP
Capillus, LLC
General & Plastic Surgery · 22d
Cleared Nov 18, 2016
V30 system, V-Form Handpiece BC Medium applicator
K162363 · GEX
Viora , Ltd.
General & Plastic Surgery · 87d
Cleared Nov 17, 2016
UltraShape System
K162163 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 107d
Cleared Nov 17, 2016
Avance Abdominal Dressing Kit
K161939 · OXJ
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 126d