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
1–24 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2026
da Vinci Xi Surgical System (IS4000)
K263592 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Oct 30, 2026
B`orze Inc Laser Family (Sorren/Adonis)
K263063 · GEX
Borze, Inc.
General & Plastic Surgery · 59d
Cleared Oct 30, 2026
RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257)
K260306 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 273d
Cleared Oct 30, 2026
Kerecis Express (50250)
K260058 · KGN
Kerecis Limited
General & Plastic Surgery · 295d
Not Cleared Oct 30, 2026
Virtuoso Endoscopy System
DEN250054 · SJS
Virtuoso Surgical, Inc.
General & Plastic Surgery · 394d
Cleared Oct 29, 2026
SWICS™
K263459 · GCJ
Bloom Surgical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 28, 2026
Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089,...
K263313 · OAP
Shenzhen Rainbow Technology Co., Ltd.
General & Plastic Surgery · 37d
Cleared Oct 28, 2026
Microwave Ablation Antennas
K261636 · NEY
Canyon Medical, Inc.
General & Plastic Surgery · 163d
Cleared Oct 28, 2026
GI Windows Flexagon Plus OTOLoc System
K261630 · SAH
GI Windows Surgical
General & Plastic Surgery · 163d
Cleared Oct 27, 2026
Tendon Anchor
K263461 · GDW
Smith & Nephew, Inc.
General & Plastic Surgery · 29d
Cleared Oct 27, 2026
OnControl Powered Bone Access Systems
K262531 · KNW
Teleflex Medical, LLC
General & Plastic Surgery · 97d
Cleared Oct 27, 2026
Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)
K262349 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 109d
Cleared Oct 27, 2026
Skin Clinic Nitro Clear for Warts and Skin Tags
K260520 · GEH
Cryoconcepts LP
General & Plastic Surgery · 252d
Cleared Oct 26, 2026
Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02,...
K262984 · OHS
Shenzhen Bway Tech Co., Ltd.
General & Plastic Surgery · 60d
Cleared Oct 26, 2026
SP Electrocautery Device (SP18 Max)
K262720 · GEI
Single Pass, Inc.
General & Plastic Surgery · 87d
Cleared Oct 26, 2026
Fractional CO2 Laser Therapy System (Z121)
K262627 · GEX
Sanhe PERFECTLASER Technology Co., Ltd.
General & Plastic Surgery · 89d
Cleared Oct 26, 2026
Triad Hydrophilic Wound Dresssing (1964, 2.5 oz)
K260285 · FRO
Coloplast Corp.
General & Plastic Surgery · 270d
Cleared Oct 23, 2026
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
K262752 · OHS
Shenzhen Xinlong Precision Plastic...
General & Plastic Surgery · 81d
Cleared Oct 23, 2026
RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
K261982 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 133d
Cleared Oct 22, 2026
PicoPeak Picosecond Nd:Yag Laser System (Bella-9)
K262701 · GEX
Beijing Sea Heart International...
General & Plastic Surgery · 83d
Cleared Oct 22, 2026
Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA)
K260920 · KGN
Berkeley Advanced Biomaterials
General & Plastic Surgery · 217d
Cleared Oct 21, 2026
Versius Surgical System (Versius Plus)
K261252 · SCV
Cmr Surgical Limited
General & Plastic Surgery · 188d
Cleared Oct 20, 2026
Picosecond Laser treatment system (Z180)
K262628 · GEX
Sanhe PERFECTLASER Technology Co., Ltd.
General & Plastic Surgery · 83d
Cleared Oct 20, 2026
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000)
K262386 · GEI
Stryker Instruments
General & Plastic Surgery · 99d