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
8473–8496 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2002
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE...
K014040 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 178d
Cleared Jun 03, 2002
WALLACH LOOP ELECTRODE
K020711 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 90d
Cleared May 31, 2002
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
K021563 · JCT
Sulzer Intratherapeutics, Inc.
General & Plastic Surgery · 18d
Cleared May 30, 2002
LIGHTLANCE LASER SKIN PERFORATOR
K013021 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 265d
Cleared May 30, 2002
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
K020673 · GEX
Wave Form Mfg., Inc.
General & Plastic Surgery · 90d
Cleared May 30, 2002
SS MATRIX
K020732 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2002
MODIFICATION TO ENTEC PLASMA WANDS
K021364 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared May 29, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K021577 · GEI
Neothermia Corp.
General & Plastic Surgery · 15d
Cleared May 28, 2002
KSEA SCB MEDIA CONTROL
K020640 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared May 28, 2002
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
K020778 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 78d
Cleared May 23, 2002
QUICKCLOT
K013390 · QSY
On Site Gas Systems, Inc.
General & Plastic Surgery · 220d
Cleared May 20, 2002
TISSUELINK BIPOLAR FLOATING BALL DEVICE
K020574 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 88d
Cleared May 20, 2002
APEX 800 LASER SYSTEM, MODEL APEX 800
K020849 · GEX
Iridex Corp
General & Plastic Surgery · 66d
Cleared May 20, 2002
SERRALESTER
K020902 · GAT
Serral, S.A. DE C.V.
General & Plastic Surgery · 61d
Cleared May 16, 2002
IMMIX BONE GRAFT EXTENDER
K013764 · KKY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared May 16, 2002
EPY-50
K020513 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 90d
Cleared May 16, 2002
BCLEAR
K020591 · FTC
Lumenis
General & Plastic Surgery · 83d
Cleared May 16, 2002
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
K020847 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 62d
Cleared May 16, 2002
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L...
K021092 · FTC
Philips Lighting Co.
General & Plastic Surgery · 42d
Cleared May 16, 2002
PHILIPS PLS9W/12/2P UVB
K021514 · FTC
Philips Lighting Co.
General & Plastic Surgery · 7d
Cleared May 15, 2002
FORTAFLEX SURGICAL SLING
K021107 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 40d
Cleared May 15, 2002
SURGASSIST FLEXSHAFT 2, MODEL FS2 14
K021249 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 26d
Cleared May 15, 2002
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · BTA
Medela AG
General & Plastic Surgery · 15d
Cleared May 13, 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
K020579 · GEI
Aaron Medical Industries
General & Plastic Surgery · 81d