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
3193–3216 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2018
Ezee Retrieval
K180579 · GCJ
Genicon, Inc.
General & Plastic Surgery · 14d
Cleared Mar 19, 2018
Reprocessed DePuy Mitek Ablation Wand
K173740 · NUJ
Renovo, Inc.
General & Plastic Surgery · 102d
Cleared Mar 16, 2018
Empower H35
K180426 · GEX
Quanta System Spa
General & Plastic Surgery · 28d
Cleared Mar 16, 2018
ARTAS System
K173358 · ONA
Restoration Robotics, Inc.
General & Plastic Surgery · 142d
Cleared Mar 16, 2018
XCelliStem Wound Powder
K172593 · KGN
Stemsys
General & Plastic Surgery · 199d
Cleared Mar 16, 2018
SOFTXIL
K171851 · MIB
Bistool
General & Plastic Surgery · 268d
Cleared Mar 15, 2018
Empower H65
K180423 · GEX
Quanta System Spa
General & Plastic Surgery · 27d
Cleared Mar 15, 2018
Ellipse Ydun
K180406 · GEX
Ellipse A/S
General & Plastic Surgery · 29d
Cleared Mar 15, 2018
miraDry System
K180396 · NEY
Miramar Labs, Inc.
General & Plastic Surgery · 30d
Cleared Mar 15, 2018
ELEMENT-TL
K180224 · GEX
Elemenic Co., Ltd.
General & Plastic Surgery · 48d
Cleared Mar 14, 2018
star RF Electrode, VIVA RF Electrode
K172012 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 254d
Cleared Mar 13, 2018
Biodesign Diaphragmatic Hernia Graft
K171817 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 267d
Cleared Mar 12, 2018
REXMONO, PDREX
K173779 · GAM
Sm Eng Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 09, 2018
UltraCor Twirl Breast Tissue Marker
K180061 · NEU
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 60d
Cleared Mar 09, 2018
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical...
K173796 · FTL
Sofradim Production
General & Plastic Surgery · 85d
Cleared Mar 09, 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management...
K173426 · OMP
Kci USA, Inc.
General & Plastic Surgery · 127d
Cleared Mar 08, 2018
SIROLaser Blue
K180044 · GEX
Dentsply Sirona
General & Plastic Surgery · 59d
Cleared Mar 08, 2018
AnastoClip GC Closure System
K173323 · FZP
LeMaitre Vascular, Inc.
General & Plastic Surgery · 139d
Cleared Mar 07, 2018
Dornier Medilas H Solvo 35 Laser
K180350 · GEX
Dornier Medtech America
General & Plastic Surgery · 27d
Cleared Mar 07, 2018
Aesculap Optilene Nonabsorbable Suture
K180321 · GAW
Aesculap, Inc.
General & Plastic Surgery · 30d
Cleared Mar 07, 2018
LMT-3000
K172818 · GEX
Lameditech Co. , Ltd.
General & Plastic Surgery · 170d
Cleared Mar 07, 2018
ALVUE Balloon Dilation System
K171939 · GCJ
Globus Medical, Inc.
General & Plastic Surgery · 252d
Cleared Mar 05, 2018
Reprocessed ArthoCare Ablation Wand
K173741 · NUJ
Renovo, Inc.
General & Plastic Surgery · 88d
Cleared Mar 02, 2018
Phoenix Wound Matrix
K173544 · QSZ
Nanofiber Solutions, Inc.
General & Plastic Surgery · 106d