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
5737–5760 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2010
AFFIRM DO DIODE LASER
K101601 · GEX
Cynosure, Inc.
General & Plastic Surgery · 107d
Cleared Sep 23, 2010
ACCUSCULPT II LASER SYSTEM
K101573 · GEX
Lutronic Corporation
General & Plastic Surgery · 108d
Cleared Sep 22, 2010
CALGAESEAL MODEL: CAS
K101097 · QSY
Bz Medical, Inc.
General & Plastic Surgery · 155d
Cleared Sep 20, 2010
E-LIGHT LINE
K092734 · GEX
Espansione Marketing S.P.A
General & Plastic Surgery · 381d
Cleared Sep 17, 2010
CO2 LASER SYSTEM
K101555 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 105d
Cleared Sep 17, 2010
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
K101366 · NUV
Chromogenex Technologies, Ltd.
General & Plastic Surgery · 123d
Cleared Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 182d
Cleared Sep 17, 2010
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY...
K100657 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 193d
Cleared Sep 17, 2010
BABY QUASAR
K091467 · ONE
Silver Bay, LLC
General & Plastic Surgery · 487d
Cleared Sep 16, 2010
PROPATCH SOFT TISSUE REPAIR MATRIX
K101587 · FTM
Cryolife, Inc.
General & Plastic Surgery · 101d
Cleared Sep 15, 2010
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K102291 · GDW
Covidien
General & Plastic Surgery · 34d
Cleared Sep 15, 2010
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM...
K100726 · GEX
Biolitec, Inc.
General & Plastic Surgery · 184d
Cleared Sep 15, 2010
MEPILEX BORDER AG DRESSING
K100029 · FRO
Molnlycke Health Care
General & Plastic Surgery · 252d
Cleared Sep 14, 2010
CABLECAP MODEL: WLF, STZ, ACM
K101496 · FST
Sensormed
General & Plastic Surgery · 105d
Cleared Sep 13, 2010
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
K101783 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 80d
Cleared Sep 10, 2010
STLASE DIODE LASER
K094049 · GEX
Dental Photonics, Inc.
General & Plastic Surgery · 253d
Cleared Sep 08, 2010
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
K101490 · ONG
Thermage, Inc.
General & Plastic Surgery · 99d
Cleared Sep 07, 2010
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
K102368 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 18d
Cleared Sep 07, 2010
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
K100442 · GCJ
Surgical Innovations Group Plc
General & Plastic Surgery · 202d
Cleared Sep 03, 2010
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
K091125 · ONE
Verilux
General & Plastic Surgery · 504d
Cleared Sep 01, 2010
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
K101506 · ONG
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 92d
Cleared Aug 30, 2010
3DHJD CAMERA SYSTEM MODEL
K101810 · GCJ
Vision Systems Group, A Division of...
General & Plastic Surgery · 62d
Cleared Aug 30, 2010
TEPHAFLEX COMPOSITE MESH
K101287 · OWT
Tepha, Inc.
General & Plastic Surgery · 115d
Cleared Aug 27, 2010
TX1 TISSUE REMOVAL SYSTEM
K101561 · LFL
American Optisurgical, Inc.
General & Plastic Surgery · 84d