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
7585–7608 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2005
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
K043486 · GEX
Topcon Medical Laser Systems, Inc.
General & Plastic Surgery · 76d
Cleared Mar 02, 2005
GYRUS PLASMA SKIN RESURFACING SYSTEM
K041999 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 219d
Cleared Mar 02, 2005
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL...
K043133 · KKY
Ceremed , Inc.
General & Plastic Surgery · 110d
Cleared Feb 25, 2005
ENDOASSIST
K043284 · GCJ
Armstrong Healthcare Limited
General & Plastic Surgery · 91d
Cleared Feb 24, 2005
ELLIPSE LIGHT SPT
K043255 · GEX
Danish Dermatologic Development A/S
General & Plastic Surgery · 92d
Cleared Feb 24, 2005
DERMILLUME, MODEL PRO1000
K043575 · GEX
Care Electronics, Inc.
General & Plastic Surgery · 59d
Cleared Feb 24, 2005
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
K050223 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 24d
Cleared Feb 24, 2005
BURANE XL
K050317 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 15d
Cleared Feb 23, 2005
SILIMED PECTORAL IMPLANT
K042054 · MIB
Silimed, Inc.
General & Plastic Surgery · 208d
Cleared Feb 23, 2005
QUADRANT RETRACTOR SYSTEM
K043602 · GAD
Medtronic Sofamor Danek
General & Plastic Surgery · 56d
Cleared Feb 22, 2005
PSD-60/ENDOPLASMA
K042274 · GEI
Olympus Shirakawa Co., Ltd.
General & Plastic Surgery · 183d
Cleared Feb 18, 2005
D-STAT RADIAL HEMOSTATIC BAND
K050133 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Feb 18, 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · FTL
Sofradim Production
General & Plastic Surgery · 22d
Cleared Feb 15, 2005
WAVELIGHT SINON
K050218 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 15d
Cleared Feb 11, 2005
MONARCH NASAL IMPLANT
K041690 · FZE
Hanson Medical, Inc.
General & Plastic Surgery · 234d
Cleared Feb 11, 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 121d
Cleared Feb 10, 2005
ELECTROSURGICAL PENCILS
K040780 · GEI
Hangzhou Shuyou Medical Instrument...
General & Plastic Surgery · 321d
Cleared Feb 09, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
K043251 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Feb 09, 2005
BONE SOURCE HAC RAPID SETTING CEMENT
K043334 · GXP
Stryker Instruments
General & Plastic Surgery · 68d
Cleared Feb 07, 2005
GEL MARK V
K050090 · NEU
Senorx, Inc.
General & Plastic Surgery · 24d
Cleared Feb 03, 2005
SYSTEM 7500-B ELECTROSURGICAL UNIT
K050161 · GEI
Conmed Electrosurgery
General & Plastic Surgery · 9d
Cleared Feb 01, 2005
COOLTOUCH, MODEL CT3S
K043046 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 89d
Cleared Feb 01, 2005
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Jan 31, 2005
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
K043173 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 76d