FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,256 results
265–288 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
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
Cleared Nov 28, 2025
Dendrite Imaging System
K253303 · QDG
Dendrite Imaging, Inc.
General & Plastic Surgery · 60d
Cleared Nov 28, 2025
Medical Diode Laser Systems (TR-B)
K252658 · GEX
Baoding Te'Anzhou Electronic...
General & Plastic Surgery · 98d
Cleared Nov 25, 2025
BELLUS-Q
K253344 · GEX
Speclipse, Inc.
General & Plastic Surgery · 56d
Cleared Nov 25, 2025
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21,...
K253304 · OHT
Dongguan Lide Electric Appliance Co.,...
General & Plastic Surgery · 57d
Cleared Nov 25, 2025
LeafPure-Echo (LM-LPNdA)
K253219 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 25, 2025
Eva Scalp Cooling System
K252289 · PMC
Stemtech Medical Devices Private Limited
General & Plastic Surgery · 125d
Cleared Nov 24, 2025
Thulium Fiber Laser System (TFL-A)
K252787 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 83d
Cleared Nov 24, 2025
Holmium Laser System (Potent HP90)
K252771 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 83d