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
6193–6216 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2009
INCISIVE FAMILY OF INPULSE ND:YAG LASERS
K083215 · GEX
Incisive, LLC
General & Plastic Surgery · 159d
Cleared Apr 08, 2009
PROWICK
K083007 · FRO
Arthrex, Inc.
General & Plastic Surgery · 182d
Cleared Apr 02, 2009
NEOSALUS CREAM
K090585 · FRO
Quinnova Pharmaceuticals
General & Plastic Surgery · 29d
Cleared Apr 02, 2009
ATMOS S041 WOUND
K090130 · OMP
Atmos, Inc.
General & Plastic Surgery · 71d
Cleared Apr 02, 2009
ASAP WOUND DRESSING GEL
K082333 · FRO
American Biotech Labs
General & Plastic Surgery · 231d
Cleared Apr 01, 2009
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
K090759 · JCX
Biodrain Medical, Inc.
General & Plastic Surgery · 9d
Cleared Apr 01, 2009
SOPRO 184 CAMERA
K082796 · GCJ
Sopro
General & Plastic Surgery · 190d
Cleared Mar 31, 2009
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
K090026 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 85d
Cleared Mar 27, 2009
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
K090410 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 37d
Cleared Mar 27, 2009
SYNTHASOME X-REPAIR
K083307 · FTL
Synthasome, Inc.
General & Plastic Surgery · 137d
Cleared Mar 27, 2009
GORE BIO-A FISTULA PLUG
K083266 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 142d
Cleared Mar 27, 2009
HYLATOPIC EMOLLIENT FOAM
K083024 · MGQ
Collegium Pharmaceutical Incorporated
General & Plastic Surgery · 169d
Cleared Mar 26, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K082662 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 195d
Cleared Mar 25, 2009
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
K083792 · HWC
Medshape Solutions
General & Plastic Surgery · 96d
Cleared Mar 20, 2009
STERIS CMAX XLT SURGICAL TABLE
K090136 · FQO
STERIS Corporation
General & Plastic Surgery · 58d
Cleared Mar 20, 2009
MYOSCIENCE CRYO-TOUCH
K083493 · GEH
Myoscience, Inc.
General & Plastic Surgery · 115d
Cleared Mar 20, 2009
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
K082819 · NEY
Miramar Labs, Inc.
General & Plastic Surgery · 176d
Cleared Mar 20, 2009
SYNCHRO HP PLATFORM
K082039 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 245d
Cleared Mar 19, 2009
TAC-TITE (TM)
K090128 · GAT
Core Essence Orthopaedics, Inc.
General & Plastic Surgery · 57d
Cleared Mar 19, 2009
AFFIRM CO2 AND AFFIRM CO2 HP
K081424 · GEX
Cynosure, Inc.
General & Plastic Surgery · 303d
Cleared Mar 18, 2009
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · NEU
C.R. Bard, Inc.
General & Plastic Surgery · 16d
Cleared Mar 18, 2009
SECURIAN TISSUE REINFORCEMENT MATRIX
K083823 · FTM
Xylos Corporation
General & Plastic Surgery · 86d
Cleared Mar 17, 2009
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
K090235 · GEX
Cynosure, Inc.
General & Plastic Surgery · 43d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 55d