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
4513–4536 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2014
SMARTGRAFT 30 SYSTEM
K141591 · MUU
Ingeneron, Inc.
General & Plastic Surgery · 103d
Cleared Sep 24, 2014
LUCID LY
K140837 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 175d
Cleared Sep 22, 2014
SIMEX SUBGLOTTIC ASPIRATION SYSTEM
K141255 · BTA
Simex Medizintechnik GmbH
General & Plastic Surgery · 131d
Cleared Sep 22, 2014
PICOSURE WORKSTATION
K140719 · GEX
Cynosure, Inc.
General & Plastic Surgery · 185d
Cleared Sep 19, 2014
XLR8 PLUS (XLR8+)
K141437 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 112d
Cleared Sep 19, 2014
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT...
K140634 · OMP
Devon Medical, Inc.
General & Plastic Surgery · 191d
Cleared Sep 19, 2014
XENMATRIX AB SURGICAL GRAFT
K133223 · PIJ
C.R. Bard, Inc.
General & Plastic Surgery · 333d
Cleared Sep 17, 2014
DA VINVI SURGICAL SYSTEM
K123329 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 691d
Cleared Sep 16, 2014
GEM Flow COUPLER Device and System
K142309 · MVR
Synovis Life Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Sep 15, 2014
HARMONIC SCALLOP BLADE, GENERATOR G11
K141122 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 138d
Cleared Sep 15, 2014
POLYCRYL
K140039 · GAM
Aurolab
General & Plastic Surgery · 251d
Cleared Sep 12, 2014
LARIAT sulture Delivery Device
K142241 · GAT
Sentreheart, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Ultra Diode Laser
K142226 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Elite Diode Laser
K142225 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Pro Diode Laser
K142223 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON...
K141033 · OMP
Argentum Medical, LLC
General & Plastic Surgery · 143d
Cleared Sep 12, 2014
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
K140367 · KGN
Harbor Medtech, Inc.
General & Plastic Surgery · 210d
Cleared Sep 11, 2014
ELITE + LASER SYSTEM
K141425 · GEX
Cynosure, Inc.
General & Plastic Surgery · 104d
Cleared Sep 10, 2014
BTL-9000
K134040 · OLI
Btl Industries, Ltd.
General & Plastic Surgery · 253d
Cleared Sep 09, 2014
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 259d
Cleared Sep 05, 2014
DEKA SMARTXIDE LASER SYSTEM
K133895 · GEX
El.En S.P.A.
General & Plastic Surgery · 259d
Cleared Sep 05, 2014
TRUSCULPT
K133739 · PBX
Cutera, Inc.
General & Plastic Surgery · 270d
Cleared Sep 04, 2014
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM...
K141272 · GCJ
Minimmally Invasive Devices
General & Plastic Surgery · 112d
Cleared Sep 04, 2014
CALCULASE II
K140964 · GEX
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 142d