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
6169–6192 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared May 04, 2009
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
K091016 · GAT
Surgical Devices, A Global Business...
General & Plastic Surgery · 25d
Cleared May 04, 2009
LUME 2 SYSTEM, MODEL GA0005000
K083733 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 139d
Cleared May 01, 2009
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
K091107 · GEI
Hemostatix Medical Technologies, LLC
General & Plastic Surgery · 15d
Cleared May 01, 2009
MONTERIS MEDICAL AUTOLITT LASER PROBE
K081509 · GEX
Monteris Medical,
General & Plastic Surgery · 337d
Cleared Apr 29, 2009
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
K091017 · FZP
Cardica, Inc.
General & Plastic Surgery · 20d
Cleared Apr 29, 2009
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
K090638 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 50d
Cleared Apr 28, 2009
ORTHOSTAT
K091121 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 11d
Cleared Apr 28, 2009
MTA PROTECTIVE SHEET
K090778 · FTM
Xylos Corporation
General & Plastic Surgery · 36d
Cleared Apr 28, 2009
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
K083203 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 180d
Cleared Apr 23, 2009
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
K083889 · GEX
Fotona D.D.
General & Plastic Surgery · 115d
Cleared Apr 23, 2009
REBOUND HRDV
K083467 · FTL
Minnesota Medical Development, Inc.
General & Plastic Surgery · 150d
Cleared Apr 22, 2009
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K091087 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 7d
Cleared Apr 22, 2009
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
K091011 · FWP
Surgical Technology Laboratories, Inc...
General & Plastic Surgery · 13d
Cleared Apr 22, 2009
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
K090070 · FST
Invuity, Inc.
General & Plastic Surgery · 100d
Cleared Apr 21, 2009
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K090872 · FZP
Cardica, Inc.
General & Plastic Surgery · 22d
Cleared Apr 17, 2009
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
K090679 · MVR
Vioptix, Inc.
General & Plastic Surgery · 32d
Cleared Apr 17, 2009
ISKRA MEDICAL GREEN IRF PRESTIGE
K083590 · GEI
Iskra Medical, D.O.O.
General & Plastic Surgery · 134d
Cleared Apr 16, 2009
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
K090631 · GCJ
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 38d
Cleared Apr 16, 2009
SILVER WOUND PAD
K083659 · FRO
Milliken & Co.
General & Plastic Surgery · 127d
Cleared Apr 14, 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
K090618 · GEX
Cynosure, Inc.
General & Plastic Surgery · 36d
Cleared Apr 14, 2009
BLUESHINE GOLD SERIES
K090297 · GEX
Blueshine Srl
General & Plastic Surgery · 67d
Cleared Apr 14, 2009
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
K083848 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 111d
Cleared Apr 10, 2009
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
K083519 · GDW
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 135d
Cleared Apr 08, 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
K090620 · QSY
Z-Medica Corporation
General & Plastic Surgery · 30d