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
3793–3816 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2016
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium...
K161311 · FRO
Strukmyer Medical, LLC
General & Plastic Surgery · 111d
Cleared Aug 26, 2016
ORION
K161503 · GEX
Yerim Engineering Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 26, 2016
FMX314 Surgical Platform
K160797 · OTJ
Fortimedix Surgical B.V.
General & Plastic Surgery · 156d
Cleared Aug 25, 2016
Exufiber Ag+
K160379 · FRO
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 197d
Cleared Aug 23, 2016
Accurett
K161615 · GEH
H&O Equipments, Nv/Sa
General & Plastic Surgery · 74d
Cleared Aug 23, 2016
GalaSHAPE 3D
K161092 · OOD
Tepha, Inc.
General & Plastic Surgery · 127d
Cleared Aug 23, 2016
Cavilon Advanced High Endurance Skin Protectant
K153571 · KMF
3M Healthcare
General & Plastic Surgery · 252d
Cleared Aug 22, 2016
Werewolf RF20000 Controller, FLOW 50 Wand
K162074 · GEI
ArthroCare Corporation
General & Plastic Surgery · 26d
Cleared Aug 19, 2016
Microcyn Plus Wound Care Solution
K161034 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 128d
Cleared Aug 19, 2016
Electrosurgical disposable grounding pads
K160366 · ODR
Top-Rank Health Care Co., Ltd.
General & Plastic Surgery · 192d
Cleared Aug 19, 2016
InMode System MiniFX Handpiece
K160329 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 196d
Cleared Aug 19, 2016
Kerecis SecureMesh
K153364 · OXE
Kerecis Limited
General & Plastic Surgery · 273d
Cleared Aug 17, 2016
LUOFUCON Silicone Ag foam dressing
K160022 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 225d
Cleared Aug 16, 2016
A.R.C. Laser Surgical Fibers and Probes
K161403 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 88d
Cleared Aug 12, 2016
Thermi RF Accessories
K161661 · GEI
Thermi
General & Plastic Surgery · 57d
Cleared Aug 12, 2016
LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open...
K160331 · GEI
Covidien
General & Plastic Surgery · 186d
Cleared Aug 12, 2016
'cottony' II TAPE, PLEDGETS
K153089 · GAT
Teleflexmedical, Inc.
General & Plastic Surgery · 291d
Cleared Aug 11, 2016
Laparoscopic Spray Applicator with Spinning Luers
K162077 · GCJ
Micromedics, Inc. (D/B/A Nordson...
General & Plastic Surgery · 15d
Cleared Aug 11, 2016
NICO TRIOwand
K162075 · GEI
Nico Corporation
General & Plastic Surgery · 15d
Cleared Aug 11, 2016
VivoSight Dx Topical OCT System
K153283 · NQQ
Michelson Diagnostics, Ltd.
General & Plastic Surgery · 273d
Cleared Aug 08, 2016
WoundClot9
K160679 · QSY
Core Scientific Creation , Ltd.
General & Plastic Surgery · 151d
Cleared Aug 08, 2016
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
K153678 · FRO
Permeaderm, Inc.
General & Plastic Surgery · 231d
Cleared Aug 07, 2016
da Vinci Xi Surgical System
K153276 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 269d
Cleared Aug 05, 2016
Triton System
K160338 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 179d