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
2713–2736 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2019
Pioneer Elite Diode Laser
K181602 · GEX
CAO Group, Inc.
General & Plastic Surgery · 448d
Cleared Sep 09, 2019
Connected OR Hub with Device and Voice Control
K192172 · GCJ
Stryker
General & Plastic Surgery · 28d
Cleared Sep 09, 2019
Sofacia System
K191421 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 104d
Cleared Sep 09, 2019
Precise SHP Diode Laser
K181601 · GEX
CAO Group, Inc.
General & Plastic Surgery · 447d
Cleared Sep 06, 2019
EVO Platform
K192160 · GEX
Quanta System Spa
General & Plastic Surgery · 28d
Cleared Sep 06, 2019
Venus Legacy Pro Device
K191528 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 88d
Cleared Sep 06, 2019
Gem FlowCoupler System
K190499 · MVR
Baxter/ Synovis Micro Companies...
General & Plastic Surgery · 189d
Cleared Sep 06, 2019
Secret RF Smartcure Applicator with electrodes
K182355 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 372d
Cleared Sep 05, 2019
Holinwon 30
K183563 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 259d
Cleared Sep 04, 2019
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · HRX
Smith & Nephew, Inc.
General & Plastic Surgery · 26d
Cleared Sep 04, 2019
GOLNIT Non-aborbable PTFE Surgical Suture
K192088 · NBY
Antarma, LLC Dba Golnit Sutures
General & Plastic Surgery · 30d
Cleared Sep 04, 2019
Signia Small Diameter Reloads
K191070 · GDW
Covidien
General & Plastic Surgery · 135d
Cleared Aug 30, 2019
LightWalker Laser System Family
K191554 · GEX
Fotona D.O.O.
General & Plastic Surgery · 79d
Cleared Aug 29, 2019
OverStitch 2-0 Polypropylene Suture
K191439 · OCW
Apollo Endosurgery
General & Plastic Surgery · 91d
Cleared Aug 29, 2019
gel-e Flex+
K182811 · QSY
Gel-E, Inc.
General & Plastic Surgery · 330d
Cleared Aug 25, 2019
810nm Diode Laser System
K183122 · GEX
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 289d
Cleared Aug 23, 2019
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi,...
K191177 · GCJ
Smith and Nephew, Inc.
General & Plastic Surgery · 113d
Cleared Aug 23, 2019
Customized Contour Implant
K191130 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 116d
Cleared Aug 23, 2019
Acare Suction Unit
K182950 · JCX
Acare Technology Co., Ltd.
General & Plastic Surgery · 304d
Cleared Aug 16, 2019
980nm Diode Laser Therapy Device
K191349 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 88d
Cleared Aug 15, 2019
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916 · FWP
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 29d
Cleared Aug 15, 2019
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K190610 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 157d
Cleared Aug 15, 2019
Viola
K190264 · NEW
Meditime Co., Ltd.
General & Plastic Surgery · 188d
Cleared Aug 15, 2019
Suprasorb A + Ag “R”
K183208 · FRO
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery · 269d