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
8329–8352 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2002
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 183d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · MDM
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Nov 13, 2002
EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS
K023492 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 26d
Cleared Nov 13, 2002
PK ZIP WING CUTTING DISSECTOR
K023493 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 26d
Cleared Nov 12, 2002
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC...
K022574 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 102d
Cleared Nov 12, 2002
ESSEX ENDOSCOPE, MODEL SXD-1000
K023627 · GCJ
Guidant Corp.
General & Plastic Surgery · 15d
Cleared Nov 12, 2002
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
K023629 · GCJ
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 15d
Cleared Nov 08, 2002
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
K023413 · GEI
Neothermia Corp.
General & Plastic Surgery · 28d
Cleared Nov 07, 2002
ARTHREX FIBERWIRE IN USP SIZES
K021434 · GAT
Arthrex, Inc.
General & Plastic Surgery · 185d
Cleared Nov 07, 2002
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
K022655 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 90d
Cleared Nov 05, 2002
THERMAGE THERMACOOL TC SYSTEM
K021402 · GEI
Thermage, Inc.
General & Plastic Surgery · 187d
Cleared Nov 05, 2002
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER...
K022610 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 91d
Cleared Nov 05, 2002
CURAD
K022645 · KMF
Beiersdorf AG
General & Plastic Surgery · 89d
Cleared Nov 04, 2002
AUTOCON II 400 ELECTROSURGICAL GENERATOR
K021467 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 181d
Cleared Nov 04, 2002
HEMCON BANDAGE
K023298 · QSY
Hemcon, Inc.
General & Plastic Surgery · 32d
Cleared Nov 01, 2002
REGENECARE WOUND GEL
K020540 · SEJ
Mpm Medical., Inc.
General & Plastic Surgery · 255d
Cleared Oct 31, 2002
PERMACOL
K021056 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 213d
Cleared Oct 31, 2002
FLASH 1
K022583 · GEX
Emed, Inc.
General & Plastic Surgery · 87d
Cleared Oct 30, 2002
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE...
K022060 · GEX
Lumenis, Inc.
General & Plastic Surgery · 127d
Cleared Oct 25, 2002
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D...
K020339 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 266d
Cleared Oct 24, 2002
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA...
K023182 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Oct 18, 2002
PLASMALITE PULSED LIGHT SYSTEM
K022378 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 88d
Cleared Oct 18, 2002
PROFILE 1320 LASER SYSTEM
K022381 · GEX
Sciton, Inc
General & Plastic Surgery · 88d
Cleared Oct 17, 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · FRO
Dynarex Corp.
General & Plastic Surgery · 421d