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
6313–6336 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2008
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
K082725 · GBX
Maquet Cardiovascular, LLC
General & Plastic Surgery · 91d
Cleared Dec 16, 2008
SKINCLEAR Q-SWITCHED ND:YAG LASER
K083272 · GEX
Global USA Distribution, LLC
General & Plastic Surgery · 40d
Cleared Dec 16, 2008
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
K082278 · NEU
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 127d
Cleared Dec 16, 2008
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
K080741 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 274d
Cleared Dec 15, 2008
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
K083211 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 45d
Cleared Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 22d
Cleared Dec 12, 2008
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
K083379 · GEX
Cynosure, Inc.
General & Plastic Surgery · 28d
Cleared Dec 12, 2008
PROLITE III TOWER AND PR AND HR HANDPIECE
K081095 · GEX
Quantel S.A.
General & Plastic Surgery · 239d
Cleared Dec 10, 2008
MODIFICATION TO ARTHROCARE ARTHROWANDS
K083306 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Dec 10, 2008
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
K082902 · GEI
Rz Medizintechnik GmbH
General & Plastic Surgery · 71d
Cleared Dec 09, 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED...
K083013 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 61d
Cleared Dec 04, 2008
TIVAMED COOLED RF SYSTEM, MODEL 78001
K082962 · GEI
Tivamed, Inc.
General & Plastic Surgery · 62d
Cleared Dec 04, 2008
LIPOSE FAT TRANSFER SYSTEM
K081848 · MUU
Lipose Corp.
General & Plastic Surgery · 157d
Cleared Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 176d
Cleared Dec 03, 2008
PULSAR GENERATOR, PEAK PLASMABLADE
K082786 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 71d
Cleared Dec 03, 2008
NO!NO! SKIN
K082423 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 103d
Cleared Dec 03, 2008
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
K082225 · GEX
Biolitec, Inc.
General & Plastic Surgery · 119d
Cleared Dec 01, 2008
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
K082535 · GAT
Surgical Devices, A Global Business...
General & Plastic Surgery · 90d
Cleared Dec 01, 2008
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
K082208 · NAC
Scivolutions, Inc.
General & Plastic Surgery · 118d
Cleared Dec 01, 2008
PROSIT WOUND TREATMENT DEVICE
K081977 · FRO
Silverleaf Medical Products, Inc.
General & Plastic Surgery · 143d
Cleared Nov 26, 2008
VERITAS COLLAGEN MATRIX (DRY)
K083039 · FTM
Synovis Surgical Innovations
General & Plastic Surgery · 43d
Cleared Nov 25, 2008
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
K082415 · OMP
Premco Medical Systems, Inc.
General & Plastic Surgery · 96d
Cleared Nov 25, 2008
VALLEYLAB MICROWAVE ABLATION GENERATOR
K072687 · NEY
Covidien Lp, Formerly Know AS...
General & Plastic Surgery · 428d
Cleared Nov 21, 2008
REXASTOM ORAL EASE
K082553 · OLR
Rexaderm, Inc.
General & Plastic Surgery · 79d