Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

OMP 2022-11-22

Renasys Edge (66803126)

Applicant Smith & Nephew Medical Limited

K-Number K223041

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ITX 2022-11-22

VitroPRO

Applicant CIVCO Medical Instruments Co., Inc.

K-Number K222052

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LLZ 2022-11-22

Vision 2, EVARVision, TrackVision 2, HeartVision 2

Applicant GE Medical Systems SCS

K-Number K223152

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GWE 2022-11-21

Vision Monitor- MonCvONE

Applicant Metrovision

K-Number K212936

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FPA 2022-11-21

Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221078

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KIF 2022-11-21

Vista BC Sealer

Applicant Inter-Med, Inc.

K-Number K221811

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DXQ 2022-11-21

Disposable Blood Pressure Cuff

Applicant Wenzhou Xikang Medical Instruments Co., Ltd.

K-Number K222420

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JDR 2022-11-21

Treace Medical Concepts (TMC) Implant Fixation System

Applicant Treace Medical Concepts

K-Number K222645

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FDI 2022-11-21

CORE-SNARE

Applicant Incore Co., Ltd.

K-Number K220846

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QIH 2022-11-21

SIS System (Version 5.6.0)

Applicant Surgical Information Sciences, Inc.

K-Number K223032

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EBW 2022-11-21

Implanter incl. Accessories

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K211358

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ODC 2022-11-21

Pentax Medical Valve Set

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K222980

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