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
6289–6312 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2009
180W CERELAS D 980NM DIODE LASER, MODEL D180
K083682 · GEX
Biolitec, Inc.
General & Plastic Surgery · 29d
Cleared Jan 09, 2009
REPROCESSED HARMONIC SCALPEL
K083060 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 87d
Cleared Jan 08, 2009
MODIFICATION TO ZENIEVA
K083721 · NAE
River'S Edge Pharmaceuticals, LLC
General & Plastic Surgery · 24d
Cleared Jan 07, 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
K082941 · FTL
Biomerix Corporation
General & Plastic Surgery · 97d
Cleared Jan 02, 2009
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082,...
K082396 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 136d
Cleared Jan 02, 2009
A-LAP SET (A-LAP, EZAXESS, TROCAR)
K082291 · GCJ
Ezsurgical
General & Plastic Surgery · 144d
Cleared Dec 31, 2008
ERBE MODEL VIO 300 D WITH ACCESSORIES
K083452 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 40d
Cleared Dec 29, 2008
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
K083355 · FRO
Blairex Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Dec 24, 2008
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
K081060 · GAQ
Core Essence Orthopaedics, LLC
General & Plastic Surgery · 254d
Cleared Dec 23, 2008
FIXATION TROCARS
K083638 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 14d
Cleared Dec 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
K083613 · GEX
Quanta System Spa
General & Plastic Surgery · 15d
Cleared Dec 22, 2008
NOVEON MODEL LS1100-03
K083476 · GEX
Nomir Medical Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Dec 22, 2008
EZLASE
K082938 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 81d
Cleared Dec 19, 2008
SURGISEAL TOPICAL SKIN ADHESIVE
K082993 · MPN
Adhezion Biomedical
General & Plastic Surgery · 73d
Cleared Dec 19, 2008
SMOOTHCOOL HR SYSTEM
K082911 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 80d
Cleared Dec 19, 2008
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM...
K082643 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 99d
Cleared Dec 19, 2008
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI...
K081207 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 234d
Cleared Dec 18, 2008
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
K083527 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 20d
Cleared Dec 18, 2008
WOUND FLUSH, STERILE WATER & NORMAL SALINE
K083042 · FRO
Nurse Assist, Inc.
General & Plastic Surgery · 65d
Cleared Dec 18, 2008
ALPHA ORTHOPAEDICS AT2 SYSTEM
K082956 · GEI
Alpha Orthopaedics
General & Plastic Surgery · 76d
Cleared Dec 18, 2008
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
K082809 · GEX
Lumenis, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 2008
GENADYNE A4 WOUND VACUUM SYSTEM
K082676 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 94d
Cleared Dec 18, 2008
VIKY
K082233 · GCJ
Endocontrol
General & Plastic Surgery · 133d
Cleared Dec 17, 2008
ML24000 UVA-1 PHOTOTHERAPY CABINET
K082731 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 90d