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
1537–1560 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2023
RENASYS™-WF White Foam NPWT Dressing Small
K213853 · OMP
Smith and Nephew Medical Limited
General & Plastic Surgery · 427d
Cleared Feb 09, 2023
extriCARE® 3000 Negative Wound Pressure Therapy System
K221223 · OMP
Alleva Medical Devices
General & Plastic Surgery · 287d
Cleared Feb 09, 2023
ATTIVA
K220505 · GEI
Italian Engineering S.R.L.
General & Plastic Surgery · 352d
Cleared Feb 08, 2023
NIRA Model 2
K222685 · OHS
Dermal Photonics Corp
General & Plastic Surgery · 155d
Cleared Feb 03, 2023
Pre-Formed Silicone Block
K223051 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 127d
Cleared Feb 03, 2023
Duoblade
K220996 · GEI
Cnc Technologies
General & Plastic Surgery · 305d
Cleared Feb 02, 2023
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K221781 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 226d
Cleared Feb 02, 2023
S.E.A.L. Hemostatic Wound Spray
K210751 · QSY
Bc3 Technologies, Inc.
General & Plastic Surgery · 692d
Cleared Feb 01, 2023
LED Light Therapy Device, KN-7000L
K222751 · GEX
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 142d
Cleared Jan 30, 2023
PHMB Wound Dressing
K221532 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 26, 2023
PALLAS Premium
K223588 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jan 25, 2023
Disposable Blood Lancets
K223314 · QRK
Huaian Hening Medical Instruments...
General & Plastic Surgery · 89d
Cleared Jan 25, 2023
Safety Lancet
K222801 · FMK
Sarstedt AG & CO KG
General & Plastic Surgery · 131d
Cleared Jan 23, 2023
Disposable Safety Lancets
K223313 · FMK
Huaian Hening Medical Instruments...
General & Plastic Surgery · 87d
Cleared Jan 23, 2023
LigaSure™ XP Maryland Jaw Sealer/Divider
K223158 · GEI
Covidien, LLC
General & Plastic Surgery · 108d
Cleared Jan 21, 2023
Sentimag System
K222832 · NEU
Endomagnetics Ltd.,
General & Plastic Surgery · 123d
Cleared Jan 20, 2023
Duetto Suprema
K223404 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Jan 20, 2023
Semi-automatic Biopsy-Needle (BIM 18/20)
K222462 · KNW
Itp Innovative Tomography Products GmbH
General & Plastic Surgery · 158d
Cleared Jan 20, 2023
TD-5010 Lancing Device and TD-5084 Sterile Lancets
K221419 · QRL
Gostar Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 19, 2023
AvalancheLase Family
K223540 · GEX
Fotona D.O.O.
General & Plastic Surgery · 55d
Cleared Jan 19, 2023
Disposable Endoscopic Cutter Stapler and Cartridge
K211197 · GDW
Changzhou Waston Medical Appliance...
General & Plastic Surgery · 638d
Cleared Jan 18, 2023
MOLLI 2
K223107 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 110d
Cleared Jan 17, 2023
Plasma IQ
K223222 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 92d
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 215d