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
3625–3648 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2017
KARL STORZ ICG Imaging System
K162882 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 104d
Cleared Jan 26, 2017
V.A.C.ULTA Negative Pressure Wound Therapy System
K162790 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 114d
Cleared Jan 24, 2017
eLyx-PRO
K162851 · GEX
Intelligent Sensory Concept SA
General & Plastic Surgery · 105d
Cleared Jan 24, 2017
Barrx Anorectal RFA Wand
K162802 · GEI
Covidien, LLC
General & Plastic Surgery · 111d
Cleared Jan 19, 2017
Ranfac Fat Aspiration Cannula
K162932 · MUU
Ranfac, Corp.
General & Plastic Surgery · 91d
Cleared Jan 19, 2017
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation...
K161418 · OMP
Cardinalhealth
General & Plastic Surgery · 241d
Cleared Jan 19, 2017
da Vinci Xi Surgical System
K161178 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 268d
Cleared Jan 18, 2017
EndoClot
K162197 · GCJ
Endoclot Plus Co., Ltd.
General & Plastic Surgery · 166d
Cleared Jan 18, 2017
Bondiloxs Topical Hemostatic Granules
K161274 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 257d
Cleared Jan 13, 2017
Magseed Magnetic Marker System
K163541 · PBY
Endomagnetics Ltd.,
General & Plastic Surgery · 28d
Cleared Jan 13, 2017
RED Light Device
K162489 · OHS
Zhongshan Bisen Plastic Electronic...
General & Plastic Surgery · 128d
Cleared Jan 12, 2017
Exilis XP II
K163176 · PBX
BTL Industries, Inc.
General & Plastic Surgery · 59d
Cleared Jan 11, 2017
Epic Pro
K163128 · GEX
Biolase, Inc.
General & Plastic Surgery · 64d
Cleared Jan 11, 2017
SPY Phi Open Field Handheld Fluorescence Imaging System
K162885 · OWN
Novadaq Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Jan 11, 2017
InSeca ARC Stylus, Aerin Console
K162810 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 97d
Cleared Jan 11, 2017
Venus Velocity Diode Laser System
K162765 · GEX
Venus Concept , Ltd.
General & Plastic Surgery · 103d
Cleared Jan 11, 2017
U-IGNITE Bladeless Trocar
K162387 · GCJ
Tianjin Uwell Medical Device...
General & Plastic Surgery · 139d
Cleared Jan 06, 2017
SpeedStitch Suture Passer
K163142 · GAT
ArthroCare Corporation
General & Plastic Surgery · 58d
Cleared Jan 06, 2017
Disc-FX System
K162490 · GEI
Elliquence, LLC
General & Plastic Surgery · 121d
Cleared Jan 05, 2017
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters,...
K163454 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 27d
Cleared Jan 05, 2017
C2 Cryoballoon Ablation System
K161202 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 252d
Cleared Jan 05, 2017
AGNES
K160469 · GEI
Gowoonsesang Cosmetics Co., Ltd.
General & Plastic Surgery · 321d
Cleared Jan 04, 2017
Relign System
K162770 · GEI
Relign Corporation
General & Plastic Surgery · 93d
Cleared Dec 23, 2016
XenMatrix AB Surgical Graft
K162193 · PIJ
C. R. Bard
General & Plastic Surgery · 141d