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
2689–2712 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2019
Aimanfun Lumea Comfort
K190820 · OHT
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 184d
Cleared Sep 30, 2019
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
K192425 · OAP
Wontech Co., Ltd.
General & Plastic Surgery · 25d
Cleared Sep 27, 2019
FlexBand Plus
K192112 · FTL
International Life Sciences
General & Plastic Surgery · 53d
Cleared Sep 27, 2019
XLR8 Abdominal Wound Dressing Kit
K182722 · OMP
Genadyne Biotechnologies
General & Plastic Surgery · 364d
Cleared Sep 26, 2019
BioZorb SP Marker
K192371 · NEU
Focal Therapeutics
General & Plastic Surgery · 27d
Cleared Sep 26, 2019
Exogenesis Hernia Mesh
K191545 · FTL
Exogenesis Corporation
General & Plastic Surgery · 107d
Cleared Sep 26, 2019
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip...
K190029 · GCJ
Changzhou Xin Neng Yuan Medical...
General & Plastic Surgery · 262d
Cleared Sep 25, 2019
NuStat
K183190 · POD
Beeken Biomedical, LLC
General & Plastic Surgery · 310d
Cleared Sep 24, 2019
SmoothSkin BARE+
K192010 · OHT
Cyden Limited
General & Plastic Surgery · 57d
Cleared Sep 23, 2019
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · MUD
Spectros Corporation
General & Plastic Surgery · 27d
Cleared Sep 20, 2019
Clyra Wound Irrigation Solution
K181428 · FRO
Clyra Medical Technologies, Inc.
General & Plastic Surgery · 476d
Cleared Sep 17, 2019
VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar...
K191947 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 57d
Cleared Sep 17, 2019
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
K191842 · GEX
Quanta System Spa
General & Plastic Surgery · 70d
Cleared Sep 17, 2019
Poly Clear
K183708 · OLP
Medtek Skincare, LLC
General & Plastic Surgery · 260d
Cleared Sep 16, 2019
PicoWay Laser System
K191685 · GEX
Candela Corporation
General & Plastic Surgery · 84d
Cleared Sep 16, 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · MUD
Vioptix, Inc.
General & Plastic Surgery · 84d
Cleared Sep 13, 2019
RFID Localization System
K190932 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 156d
Cleared Sep 13, 2019
Roosin Xeroform Petrolatum Dressing
K181478 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 465d
Cleared Sep 12, 2019
Capillus 112, Capillus 244
K192012 · OAP
Capillus
General & Plastic Surgery · 45d
Cleared Sep 12, 2019
faceLITE
K191629 · OHS
Ismart Marketing Svcs, Ltd.
General & Plastic Surgery · 85d
Cleared Sep 12, 2019
CO2 Laser System
K191518 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 97d
Cleared Sep 12, 2019
Saline Wound Wash, SteriCleanse(TM)
K183662 · FRO
Ascent Consumer Products, Inc.
General & Plastic Surgery · 259d
Cleared Sep 10, 2019
BH Medical Dental Barrier Sleeves and Barrier Film
K190484 · PEM
Bh Medical Products Co., Ltd.
General & Plastic Surgery · 195d
Cleared Sep 10, 2019
Sterling Supreme Diode Laser
K181614 · GEX
CAO Group, Inc.
General & Plastic Surgery · 448d