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
3577–3600 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2017
FUJIFILM Surgical System
K162836 · GCJ
Fujifilm New Development U.S.A., Inc.
General & Plastic Surgery · 153d
Cleared Mar 11, 2017
PROLENE Soft Polypropylene Mesh
K163152 · FTL
Ethicon, Inc.
General & Plastic Surgery · 121d
Cleared Mar 10, 2017
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist...
K170508 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 17d
Cleared Mar 10, 2017
InterLock Trocar
K170084 · GCJ
Fujifilm New Development U.S.A., Inc.
General & Plastic Surgery · 59d
Cleared Mar 09, 2017
FLEX Microwave Ablation System and Accessories
K163118 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 121d
Cleared Mar 08, 2017
Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency...
K170188 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 44d
Cleared Mar 08, 2017
VersaOne fascial closure system bladed trocar, VersaOne fascial closure...
K163654 · GCJ
Covidien, LLC
General & Plastic Surgery · 75d
Cleared Mar 08, 2017
VIVA combo RF System
K163450 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 06, 2017
Next Science Wound Gel (Rx)
K163188 · FRO
Next Science, LLC
General & Plastic Surgery · 112d
Cleared Mar 03, 2017
Cyber Ho
K170331 · GEX
Quanta System Spa
General & Plastic Surgery · 29d
Cleared Mar 03, 2017
iPulse SmoothSkin BARE Hair Removal Device
K163552 · OHT
Cyden Limited
General & Plastic Surgery · 74d
Cleared Mar 03, 2017
Disposable End-to-end Anastomosis Circular Stapler
K162947 · GDW
Chongqing Qmi Surgical Co., Ltd.
General & Plastic Surgery · 133d
Cleared Mar 03, 2017
Curasite
K161991 · FRO
Izun Pharmaceuticals
General & Plastic Surgery · 227d
Cleared Mar 02, 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · GDW
Covidien
General & Plastic Surgery · 27d
Cleared Mar 02, 2017
Slimming Treatment Device
K161892 · NUV
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 234d
Cleared Mar 02, 2017
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
K161737 · NEW
Myco Medical
General & Plastic Surgery · 252d
Cleared Mar 02, 2017
REXLON, REXSIL
K161633 · GAR
Sm Eng Co., Ltd.
General & Plastic Surgery · 262d
Cleared Feb 28, 2017
Jac-Cell Medic testers
K170105 · GEI
Jac-Cell Medic
General & Plastic Surgery · 47d
Cleared Feb 28, 2017
Smart Laser Indirect Ophthalmoscope (LIO)
K162837 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 140d
Cleared Feb 24, 2017
ARTIA Reconstructive Tissue Matrix Perforated
K162752 · FTM
Lifecell Corporation
General & Plastic Surgery · 147d
Cleared Feb 24, 2017
IllumiFlow Laser Cap
K162071 · OAP
Eglobal, LLC
General & Plastic Surgery · 212d
Cleared Feb 24, 2017
The Red Head Collection Device, The Jordy Connection System
K161372 · MUU
Miami Fat Supply
General & Plastic Surgery · 283d
Cleared Feb 23, 2017
GalaFORM 3D
K162922 · OOD
Tepha, Inc.
General & Plastic Surgery · 128d
Cleared Feb 23, 2017
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
K161693 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 248d