Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LZH 2023-10-23

Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set

Applicant Vesco Medical, LLC

K-Number K232205

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GEI 2023-10-23

CleanSeal Advanced Bipolar Vessel Sealer Maryland

Applicant Conmed Corporation

K-Number K231732

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LNH 2023-10-23

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K231560

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IYN 2023-10-23

Ultrasound System 1300

Applicant Bk Medical Aps

K-Number K231764

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NUC 2023-10-22

JO Coconut Hybrid Cooling Personal Lubricant

Applicant CC Wellness, LLC

K-Number K232091

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POL 2023-10-21

pRESET LITE Thrombectomy Device

Applicant Phenox Limited

K-Number K231539

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QIH 2023-10-20

Sonix Health

Applicant Ontact Health Co., Ltd.

K-Number K230209

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LLZ 2023-10-20

R2GATE Lite TM

Applicant Megagen Implant Co., Ltd.

K-Number K223909

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EBI 2023-10-20

NextDent Base

Applicant Vertex-Dental B.V.

K-Number K231388

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FDF 2023-10-20

Pure-Vu EVS System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K232922

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KPI 2023-10-20

Unicare (K-UNICARE-USA)

Applicant Tenscare, Ltd.

K-Number K230983

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KGO 2023-10-20

GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

Applicant Ansell Healthcare

K-Number K231902

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