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
5305–5328 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2012
FOTONA XP ND: YAG LASER SYSTEM
K113702 · PDZ
Fotona D.D.
General & Plastic Surgery · 103d
Cleared Mar 27, 2012
INSULATION TESTER
K120416 · GEI
Spectrum Surgical Supply Corp.
General & Plastic Surgery · 46d
Cleared Mar 23, 2012
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
K113866 · KGN
Brennen Medical, LLC
General & Plastic Surgery · 84d
Cleared Mar 23, 2012
I-LIPO SYSTEM
K111501 · OLI
Chromogenex Technologies Limited
General & Plastic Surgery · 297d
Cleared Mar 22, 2012
GENII GI 4000 ELECTROSUGICAL GENERATOR
K113265 · GEI
Genii, Inc.
General & Plastic Surgery · 139d
Cleared Mar 16, 2012
INSORB ABSORBALBE STAPLE
K120373 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 39d
Cleared Mar 16, 2012
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
K113763 · GAW
Nobles Medical Technologies Ii, Inc.
General & Plastic Surgery · 86d
Cleared Mar 15, 2012
ENDOSCOPIC APPLICATOR
K120608 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 15d
Cleared Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 148d
Cleared Mar 13, 2012
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
K113688 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 89d
Cleared Mar 13, 2012
OSTEOCOOL (TM) RF ABLATION SYSTEM
K111523 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 286d
Cleared Mar 12, 2012
VISUAL-ICE CRYOABLATION SYSTEM
K113860 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 73d
Cleared Mar 09, 2012
SURGICAL RETRACTORS
K112659 · GCJ
Surgical Innovations Plc
General & Plastic Surgery · 178d
Cleared Mar 08, 2012
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810 · PDZ
Alma Lasers, Inc.
General & Plastic Surgery · 76d
Cleared Mar 08, 2012
IFS LASER SYSTEM
K113151 · GEX
Abbott Medical Optics, Inc.
General & Plastic Surgery · 135d
Cleared Mar 07, 2012
DEXERYL CREAM
K113807 · FRO
Pierre Fabre Medical Devices
General & Plastic Surgery · 75d
Cleared Mar 07, 2012
PUREGRAFT 850/PURE SYSTEM
K113255 · MUU
Cytori Therapeutics, Inc.
General & Plastic Surgery · 125d
Cleared Mar 02, 2012
LASER HELMET
K113097 · OAP
Theradome, Inc.
General & Plastic Surgery · 135d
Cleared Mar 02, 2012
VENUS FREEZE (MP)2 SYSTEM
K111670 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 261d
Cleared Mar 01, 2012
AONGEN DENTAL COLLAGEN MATRIX
K112568 · OLR
Aeon Astron Europe B.V.
General & Plastic Surgery · 177d
Cleared Mar 01, 2012
OASYS SURGICAL LIGHT CONTROLLER
K112133 · FTA
Oasys Healthcare
General & Plastic Surgery · 219d
Cleared Feb 29, 2012
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA...
K120258 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 33d
Cleared Feb 29, 2012
CLEANE / CLEANE POP
K111341 · OZC
Medicon Co., Ltd.
General & Plastic Surgery · 293d
Cleared Feb 28, 2012
TISSUE MARKER
K113202 · NEU
Focal Therapeutics
General & Plastic Surgery · 120d