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
5497–5520 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2011
VISION ONE LASER SYSTEM
K111213 · GEX
Lumenis, Inc.
General & Plastic Surgery · 84d
Cleared Jul 22, 2011
MP 719
K111524 · MTJ
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 50d
Cleared Jul 22, 2011
SLIM E30 II CO2 LASER
K110984 · ONG
Lasering S.R.L.
General & Plastic Surgery · 106d
Cleared Jul 21, 2011
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
K111280 · OMP
Kci USA, Inc.
General & Plastic Surgery · 76d
Cleared Jul 21, 2011
CI-SNAP WOUND CARE SYSTEM
K111006 · OKO
Spiracur, Inc.
General & Plastic Surgery · 101d
Cleared Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
K111144 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Jul 18, 2011
DOMAIN SURGICAL SYSTEM
K110439 · GEI
Domain Surgical, Inc.
General & Plastic Surgery · 153d
Cleared Jul 18, 2011
REPROCESSED ELECTROSURGICAL INSTRUMENT
K110189 · NUJ
Ascent Healthcare Solutions
General & Plastic Surgery · 175d
Cleared Jul 14, 2011
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
K111065 · GWO
Howmedica Osteonics Corp. Dba Stryker...
General & Plastic Surgery · 87d
Cleared Jul 11, 2011
ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT
K110824 · GEI
Aragon Surgical, Inc.
General & Plastic Surgery · 110d
Cleared Jul 08, 2011
MEDIOSTAR NEXT
K111851 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 9d
Cleared Jul 01, 2011
CORTEX CO2 / ER:YAG LASER SYSTEM
K110897 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 93d
Cleared Jul 01, 2011
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO,...
K101306 · GEX
Fotona D.D.
General & Plastic Surgery · 417d
Cleared Jun 29, 2011
MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER
K111672 · GEI
Pacific Hospital Supply Co., Ltd.
General & Plastic Surgery · 14d
Cleared Jun 28, 2011
BIPOLAR HF DEVICE
K110695 · GEI
Aesculap, Inc.
General & Plastic Surgery · 106d
Cleared Jun 28, 2011
MEDART DIODE LASER SYSTEM & ACCESSORIES
K110243 · GEX
Medart A/S
General & Plastic Surgery · 152d
Cleared Jun 28, 2011
HALIFAX BIOMEDICAL TANATLUM BEAD SET
K103417 · NEU
Halifax Biomedical, Inc.
General & Plastic Surgery · 218d
Cleared Jun 23, 2011
SOUND SURGICAL VASER 2.1 LIPO SYSTEM
K110306 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 141d
Cleared Jun 23, 2011
WART FREEZE
K101049 · GEH
Koninklijke Utermohlen NV
General & Plastic Surgery · 435d
Cleared Jun 22, 2011
PALOMAR ICON (TM) AESTHETIC SYSTEM
K110907 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 83d
Cleared Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 107d
Cleared Jun 22, 2011
CUTERA QSWITCH LASER SYSTEM
K102954 · GEX
Cutera, Inc.
General & Plastic Surgery · 260d
Cleared Jun 22, 2011
CORELEADER ALGIPLASTER MODEL AP 050501
K102942 · FRO
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 261d
Cleared Jun 21, 2011
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
K110946 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 78d