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
3865–3888 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2016
Collagen Dental Wound Dressings
K152600 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 286d
Cleared Jun 21, 2016
Acne Light Therapy Wand
K160691 · OLP
Zuko, Inc.
General & Plastic Surgery · 102d
Cleared Jun 20, 2016
Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical...
K161134 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 59d
Cleared Jun 20, 2016
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
K160451 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 123d
Cleared Jun 16, 2016
Endoform Reconstructive Template
K153632 · FTL
Aroa Biosurgery Limited (Formerly...
General & Plastic Surgery · 181d
Cleared Jun 16, 2016
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX...
K153076 · GAT
Teleflexmedical, Inc.
General & Plastic Surgery · 237d
Cleared Jun 15, 2016
Tria Sapphire
K160821 · OLP
Tria Beauty, Inc.
General & Plastic Surgery · 83d
Cleared Jun 15, 2016
BiZact Open Sealer/Divider
K160539 · GEI
Covidien
General & Plastic Surgery · 110d
Not Cleared Jun 13, 2016
Magnetic Surgical System
DEN150007 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 489d
Cleared Jun 10, 2016
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science...
K160095 · FRO
Simple Science, LLC
General & Plastic Surgery · 143d
Cleared Jun 09, 2016
ATOVEN-Reusable Laser Fiber
K152667 · GEX
Diotech CO
General & Plastic Surgery · 266d
Cleared Jun 08, 2016
Sony IP Converter NU-IP40S
K161122 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 48d
Cleared Jun 08, 2016
Miromatrix Biological Mesh
K160400 · OXH
Miromatrix Medical, Inc.
General & Plastic Surgery · 117d
Cleared Jun 03, 2016
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture...
K153611 · GAM
Ethicon, LLC
General & Plastic Surgery · 169d
Cleared Jun 03, 2016
LunulaLaser
K153164 · PDZ
Erchonia Medical, Inc.
General & Plastic Surgery · 214d
Cleared Jun 02, 2016
O-pel Laser and families of probe delivery devices
K160012 · GEX
Precise Light Surgical
General & Plastic Surgery · 150d
Cleared Jun 02, 2016
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head,...
K153606 · GCJ
Smith & Nephew
General & Plastic Surgery · 168d
Cleared Jun 02, 2016
Helios III
K152856 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 247d
Cleared Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
K152519 · FRO
Medical Technology Research, Inc.
General & Plastic Surgery · 273d
Cleared Jun 02, 2016
ABC D-FLEX PROBE
K151229 · GEI
Conmed Corporation
General & Plastic Surgery · 392d
Cleared Jun 01, 2016
Voyant Open Fusion Device
K153288 · GEI
Applied Medical Resources
General & Plastic Surgery · 201d
Cleared May 31, 2016
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners,...
K160900 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 60d
Cleared May 31, 2016
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non...
K160623 · GAP
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 88d
Cleared May 31, 2016
KARL STORZ Endoscopic ICG Imaging System
K152583 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 264d