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
289–312 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2025
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling...
K252167 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 162d
Cleared Dec 19, 2025
LIA Console (542-7)
K251730 · NQQ
Leadoptik, Inc.
General & Plastic Surgery · 196d
Cleared Dec 19, 2025
JOULE 1064nm System and Accessories
K251077 · GEX
Sciton, Inc
General & Plastic Surgery · 255d
Cleared Dec 19, 2025
CO2 Laser Therapy System (Model: LFS-D9U)
K250998 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 262d
Cleared Dec 19, 2025
MatriDerm pluS+ Bi-Layer
K250864 · KGN
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 273d
Cleared Dec 18, 2025
MOVIVA® Hybrid Ablation Probe
K253915 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 10d
Cleared Dec 17, 2025
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
K252983 · OHS
Shenzhen Goodwind Technology...
General & Plastic Surgery · 90d
Cleared Dec 17, 2025
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
K252739 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 111d
Cleared Dec 16, 2025
TroClose 1200
K253620 · GAM
Gordian Surgical, Ltd.
General & Plastic Surgery · 28d
Cleared Dec 16, 2025
Versius Surgical System (Versius Plus)
K252111 · SCV
Cmr Surgical Limited
General & Plastic Surgery · 162d
Cleared Dec 15, 2025
da Vinci SP Surgical System (SP1098)
K252675 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Dec 15, 2025
Erchonia CLX (Model # CFL)
K252574 · OLI
Erchonia Corporation
General & Plastic Surgery · 123d
Cleared Dec 15, 2025
MFUSE (MS001)
K250319 · QSY
Machina Medical, Inc.
General & Plastic Surgery · 314d
Cleared Dec 12, 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · QSY
Cresilon, Inc.
General & Plastic Surgery · 24d
Cleared Dec 12, 2025
Halo Sterile Single-use Radial Fiber...
K252745 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 105d
Cleared Dec 12, 2025
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 109d
Cleared Dec 12, 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · NEU
Breast-Med, Inc.
General & Plastic Surgery · 168d
Cleared Dec 09, 2025
Lancing device (HH-XV-T)
K253706 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 15d
Cleared Dec 09, 2025
Focused Cryotherapy System
K250742 · GEH
Focused Cryo, Inc.
General & Plastic Surgery · 273d
Cleared Dec 08, 2025
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5,...
K252994 · OHS
Guangdong Ace-Tec Co., Ltd.
General & Plastic Surgery · 81d
Cleared Dec 05, 2025
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909,...
K252142 · OHS
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 150d
Cleared Dec 03, 2025
Hugo™ RAS System
K250725 · SCV
Covidien, LLC
General & Plastic Surgery · 268d
Cleared Dec 02, 2025
da Vinci SP Surgical System (SP1098)
K252069 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 154d
Cleared Dec 01, 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
K252786 · OLI
Shenzhen Suyzeko Limited.
General & Plastic Surgery · 90d