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
4177–4200 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2015
Cook ECM Powder
K152033 · KGN
Cook Biotech Incorporated
General & Plastic Surgery · 28d
Cleared Aug 19, 2015
TraceIT Tissue Marker - 3mL
K151998 · NEU
Augmenix, Inc.
General & Plastic Surgery · 30d
Cleared Aug 18, 2015
Nexus Suture
K151009 · GAT
Baylis Medical Company, Inc.
General & Plastic Surgery · 125d
Cleared Aug 14, 2015
Wartie Advanced Wart Remover or other proprietary name
K151309 · GEH
Youmedical Corp BV
General & Plastic Surgery · 88d
Cleared Aug 13, 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral...
K151200 · GAM
Ethicon, Inc.
General & Plastic Surgery · 100d
Cleared Aug 13, 2015
Stryker Suture Tape
K150584 · GAT
Stryker
General & Plastic Surgery · 157d
Cleared Aug 12, 2015
LightSheer Desire Light Laser System
K151947 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 28d
Cleared Aug 10, 2015
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless...
K141594 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 423d
Cleared Aug 07, 2015
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
K143017 · FRO
Laboratoires Urgo
General & Plastic Surgery · 291d
Cleared Aug 07, 2015
LEECH, MEDICINAL
K140907 · NRN
Carolina Biological Supply Co.
General & Plastic Surgery · 486d
Cleared Aug 06, 2015
VIKINI Diode Laser System
K151232 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 90d
Cleared Aug 05, 2015
OPTIS Integrated System Mobile Workstation
K151286 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 83d
Cleared Aug 04, 2015
Bovie J-Plasma Handpiece
K151325 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 78d
Cleared Aug 04, 2015
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse...
K150735 · GEI
Covidien
General & Plastic Surgery · 137d
Cleared Aug 04, 2015
Venus Legacy CX
K143554 · PBX
Venus Concept , Ltd.
General & Plastic Surgery · 232d
Cleared Jul 31, 2015
HEMO-Bandage
K151204 · QSY
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 87d
Cleared Jul 31, 2015
GME ExSys 308
K150752 · FTC
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 130d
Cleared Jul 30, 2015
XenMatrix AB Surgical Graft
K151177 · PIJ
C. R. Bard
General & Plastic Surgery · 90d
Cleared Jul 29, 2015
Cellfina System
K150505 · OUP
Ulthera, Inc.
General & Plastic Surgery · 154d
Cleared Jul 29, 2015
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony...
K150377 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 166d
Cleared Jul 28, 2015
Barrx Anorectal RFA Wand
K150251 · GEI
Covidien, LLC
General & Plastic Surgery · 175d
Cleared Jul 27, 2015
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter...
K150924 · GZB
Anchor Innovation Medical (A.I.M.)
General & Plastic Surgery · 112d
Cleared Jul 24, 2015
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
K150906 · FTL
Ehicon, Inc.
General & Plastic Surgery · 112d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...
K143133 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 265d