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
3745–3768 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2016
Indiba Diathermia Radiofrequency Device - Activ
K161458 · PBX
Indiba USA, Inc.
General & Plastic Surgery · 130d
Cleared Oct 03, 2016
Dynarex Xeroform Petrolatum Dressing
K152970 · FRO
Dynarex Corporation
General & Plastic Surgery · 361d
Cleared Sep 30, 2016
LaserCap300, LaserCap224, LaserCap120, LaserCap80
K161875 · OAP
Transdermal Cap, Inc.
General & Plastic Surgery · 84d
Cleared Sep 30, 2016
Atteris Antimicrobial Skin Protectant
K161212 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 155d
Cleared Sep 29, 2016
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
K162416 · GEX
Iridex Corporation
General & Plastic Surgery · 30d
Cleared Sep 29, 2016
Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac...
K162126 · GEI
ArthroCare Corporation
General & Plastic Surgery · 59d
Cleared Sep 29, 2016
EZEE RETRIEVAL
K162059 · GCJ
Genicon, Inc.
General & Plastic Surgery · 65d
Cleared Sep 29, 2016
Phasix Mesh
K161424 · OOD
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared Sep 29, 2016
RENASYS GO
K152163 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 423d
Cleared Sep 28, 2016
Aprima Smartesis Centesis Pump
K161002 · BTA
Cook Incorporated
General & Plastic Surgery · 170d
Cleared Sep 28, 2016
Flowable Wound Matrix
K160136 · KGN
Cook Biotech Incorporated
General & Plastic Surgery · 252d
Cleared Sep 26, 2016
Xenocor Xenoscope Laparoscopic System
K161838 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 83d
Cleared Sep 26, 2016
PK AIM
K161825 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 87d
Cleared Sep 26, 2016
LUCERNA Dental Laser
K161185 · GEX
Viax Dental Lab
General & Plastic Surgery · 152d
Cleared Sep 23, 2016
Photonica Professional
K160880 · OLI
Ward Photonics, LLC
General & Plastic Surgery · 177d
Cleared Sep 22, 2016
Aerin Medical Stylus
K161994 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 65d
Cleared Sep 22, 2016
DONASORB SILVER WOUND DRESSING
K153565 · FRO
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 283d
Cleared Sep 21, 2016
da Vinci Xi 12 – 8 mm Reducer
K162411 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d
Cleared Sep 21, 2016
Sterling 5W Diode Laser
K160413 · GEX
CAO Group, Inc.
General & Plastic Surgery · 218d
Cleared Sep 20, 2016
PINPOINT Endoscopic Fluorescence Imaging System
K161792 · GCJ
Novadaq Technologies, Inc.
General & Plastic Surgery · 82d
Cleared Sep 20, 2016
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm),...
K161086 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 155d
Cleared Sep 16, 2016
LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
K161804 · GEI
Covidien
General & Plastic Surgery · 78d
Cleared Sep 16, 2016
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse...
K161162 · GEX
Ellipse A/S
General & Plastic Surgery · 144d
Cleared Sep 16, 2016
NutraStim Hair Laser Helmet
K160728 · OAP
Nutra Luxe MD, LLC
General & Plastic Surgery · 184d