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
6577–6600 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2008
CRYOMINI
K080735 · GEX
Zimmer Elektromedizin GmbH
General & Plastic Surgery · 18d
Cleared Apr 04, 2008
TETRIX CREAM
K071483 · FRO
Coria Laboratories, Ltd.
General & Plastic Surgery · 310d
Cleared Apr 03, 2008
LTM-T SURGICAL MESH
K080353 · FTL
Lifecell Corp.
General & Plastic Surgery · 52d
Cleared Apr 03, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K073534 · GEX
Candela Corp.
General & Plastic Surgery · 108d
Cleared Apr 02, 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · FZP
Aesculap, Inc.
General & Plastic Surgery · 16d
Cleared Apr 02, 2008
ERBE VIO ESU, MODEL VIO 200 S
K080715 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 20d
Cleared Apr 02, 2008
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
K080557 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 34d
Cleared Apr 02, 2008
ONCOBIONIC SYSTEM
K080376 · OAB
Oncobionic Incorporated
General & Plastic Surgery · 50d
Cleared Mar 31, 2008
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
K080698 · NEU
Senorx, Inc.
General & Plastic Surgery · 19d
Cleared Mar 31, 2008
ARTHROCARE ORTHOWAND SURGICAL DEVICE
K080610 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Mar 27, 2008
HABIB HEXABLATE 10
K080717 · GEI
Emcision , Ltd.
General & Plastic Surgery · 14d
Cleared Mar 27, 2008
PORTRAIT PSR, MODEL 745915
K073111 · GEI
Rhytec Incorporated
General & Plastic Surgery · 143d
Cleared Mar 26, 2008
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
K080104 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 72d
Cleared Mar 26, 2008
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
K073583 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 97d
Cleared Mar 25, 2008
E-VAC
K073455 · GEI
New Leaf Medical, Inc.
General & Plastic Surgery · 106d
Cleared Mar 21, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
K080680 · NEW
Surgical Specialties Corp
General & Plastic Surgery · 11d
Cleared Mar 21, 2008
VIRTUAL PORTS ENDOCLEAR SYSTEM
K080051 · GCJ
Virtual Ports, Ltd.
General & Plastic Surgery · 73d
Cleared Mar 21, 2008
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 109d
Cleared Mar 20, 2008
ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
K080482 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Mar 19, 2008
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND...
K080291 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 44d
Cleared Mar 19, 2008
TUMARK PROFESSIONAL, MODEL 271560
K073095 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 139d
Cleared Mar 19, 2008
SINUS SPACER
K072891 · KAM
Acclarent, Inc.
General & Plastic Surgery · 161d
Cleared Mar 17, 2008
SUTTER ELECTROSURGICAL CABLES
K073450 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 98d
Cleared Mar 14, 2008
NOCC HYDROPHILIC WOUND DRESSING
K080010 · KGN
Kytogenics, Inc.
General & Plastic Surgery · 71d