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
6409–6432 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2008
RENASYS EZ
K082426 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 14d
Cleared Sep 05, 2008
TBD ETHICON MESH
K082216 · FTL
Ethicon, Inc.
General & Plastic Surgery · 30d
Cleared Sep 05, 2008
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
K081225 · FZP
Cardica, Inc.
General & Plastic Surgery · 128d
Cleared Sep 04, 2008
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
K080412 · GAM
Shanghai Pudong Jinhuan Medical...
General & Plastic Surgery · 202d
Cleared Sep 03, 2008
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K081042 · NEY
Bsd Medical Systems Corp.
General & Plastic Surgery · 145d
Cleared Sep 03, 2008
STARLIGHT, MODEL PD9012
K073317 · GEX
F.P. Rubinstein Y Cia S.R.L.
General & Plastic Surgery · 282d
Cleared Aug 28, 2008
ARTHROCARE ARTHROWANDS
K082323 · GEI
Arthrocare Corp.
General & Plastic Surgery · 14d
Cleared Aug 28, 2008
CLAROS NANO DENTAL LASER SYSTEM
K081652 · GEX
Elexxion AG
General & Plastic Surgery · 77d
Cleared Aug 28, 2008
GENESIS
K081559 · GEI
Medisiss
General & Plastic Surgery · 86d
Cleared Aug 28, 2008
SILVER ANTIMICROBIAL WOUND GEL
K073197 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 289d
Cleared Aug 28, 2008
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
K071023 · GDW
Reach Surgical, Inc.
General & Plastic Surgery · 505d
Cleared Aug 27, 2008
SCULPTURE 2.94 ER:YAG SYSTEM
K073158 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 293d
Cleared Aug 22, 2008
RHYTEC, INC., PORTRAIT PSR
K082197 · GEI
Rhytec Incorporated
General & Plastic Surgery · 18d
Cleared Aug 20, 2008
MEDILAS D FAMILY LASERS
K073427 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 258d
Cleared Aug 18, 2008
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
K081853 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 49d
Cleared Aug 18, 2008
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
K073579 · FTL
Feg Textiltechnik Forschungs-Und...
General & Plastic Surgery · 242d
Cleared Aug 18, 2008
SURGIMESH XB
K072974 · FTL
Aspide Medical
General & Plastic Surgery · 301d
Cleared Aug 15, 2008
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
K080530 · GEX
Cutera, Inc.
General & Plastic Surgery · 171d
Cleared Aug 13, 2008
SERIES SY DISPOSABLE ELECTROSURGICAL PAD
K082204 · ODR
Ventlab Corp.
General & Plastic Surgery · 8d
Cleared Aug 13, 2008
BODY-JET
K082025 · QPB
Human Med AG
General & Plastic Surgery · 27d
Cleared Aug 13, 2008
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
K081459 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 82d
Cleared Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
K081126 · FTL
Sofradim Production
General & Plastic Surgery · 114d
Cleared Aug 12, 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
K081939 · GEX
Omniguide, Inc.
General & Plastic Surgery · 35d
Cleared Aug 12, 2008
ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS
K081647 · GEI
Xodus Medical, Inc.
General & Plastic Surgery · 61d