Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
385–408 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
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 CT 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
Cleared Nov 24, 2025
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB,...
K252704 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 89d
Cleared Nov 22, 2025
KARL STORZ Cholangiography Set
K250927 · GCJ
Karl Storz SE & CO. KG
General & Plastic Surgery · 239d
Cleared Nov 21, 2025
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White...
K250586 · OMP
Deroyal Industries, Inc.
General & Plastic Surgery · 267d
Cleared Nov 20, 2025
CuRAS hybrid
K253123 · GEX
Classys, Inc.
General & Plastic Surgery · 56d
Cleared Nov 20, 2025
Laser Fiber (PT-OF-A-S)
K253007 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 62d
Cleared Nov 20, 2025
Disposable Polymer Ligation Clips
K250643 · FZP
Hangzhou Kangji Medical Instrument...
General & Plastic Surgery · 261d
Cleared Nov 20, 2025
Nuvis® Wireless HD Camera System (Nuvis-2K)
K242606 · GCJ
Integrated Endoscopy, Inc.
General & Plastic Surgery · 447d
Cleared Nov 19, 2025
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
K253073 · OHS
Sunglor Technology Co., Ltd.
General & Plastic Surgery · 57d