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
3121–3144 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared May 31, 2018
SOMAVAC Device
K180606 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 85d
Cleared May 31, 2018
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K173906 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 160d
Cleared May 31, 2018
EndoWrist 5mm Thoracic Grasper
K173415 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 211d
Cleared May 25, 2018
TransEnterix Senhance Surgical System
K180163 · NAY
Transenterix, Inc.
General & Plastic Surgery · 126d
Cleared May 25, 2018
SURECELL Gelling Fiber Wound Dressing
K173005 · KGN
Jiangsu Newvalue Medical Producst...
General & Plastic Surgery · 240d
Cleared May 25, 2018
Automatic Tissue Processing Unit
K172717 · MUU
Bsl Co.
General & Plastic Surgery · 259d
Cleared May 23, 2018
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length
K180403 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 98d
Cleared May 22, 2018
DiLumen Endolumenal Interventional Scissors (DiLumen Is)
K173405 · GEI
Lumendi, LLC
General & Plastic Surgery · 203d
Cleared May 18, 2018
Irrigation Tubing Bipolar Cord Set
K180908 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 42d
Cleared May 18, 2018
JOULE SYSTEM
K180508 · GEX
Sciton, Inc
General & Plastic Surgery · 81d
Cleared May 18, 2018
Theradome LH40
K180460 · OAP
Theradome, Inc.
General & Plastic Surgery · 87d
Cleared May 18, 2018
XSTAT 30, 1-Pack
K180051 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 130d
Cleared May 15, 2018
ICEfx Cryoablation System
K181153 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 14d
Cleared May 15, 2018
reVive Light Therapy LED Ultrasonic Wrinkle System
K180445 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 84d
Cleared May 11, 2018
Cytal Wound Particulate
K180776 · KGN
Acell, Inc.
General & Plastic Surgery · 49d
Cleared May 11, 2018
Light based hair removal device
K180383 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 88d
Cleared May 11, 2018
ALGS6 Ag Alginate Wound Dressing
K172570 · FRO
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 256d
Cleared May 10, 2018
Rondek PGA Suture (Beige or Violet)
K180625 · GAM
Rk Manufacturing Corporation
General & Plastic Surgery · 62d
Cleared May 09, 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound...
K172145 · OMP
Medela AG
General & Plastic Surgery · 296d
Cleared May 08, 2018
Empower H100, Cyber Ho 100, Litho 100
K180922 · GEX
Quanta System Spa
General & Plastic Surgery · 29d
Cleared May 07, 2018
Endopath Electrosurgery Probe Plus II
K180031 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 123d
Not Cleared May 07, 2018
Hemospray Endoscopic Hemostat
DEN170015 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 424d
Cleared May 04, 2018
Ulthera System
K180623 · OHV
Ulthera, Inc.
General & Plastic Surgery · 56d
Cleared May 04, 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K173874 · GAM
Origami Surgical, LLC
General & Plastic Surgery · 134d