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

PDU 2022-03-01

GoBack Crossing Catheter

Applicant Upstream Peripheral Technologies, Ltd.

K-Number K211802

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FLL 2022-03-01

Sterile Disposable Temperature Probe

Applicant Shenzhen Envisen Industry Co., Ltd.

K-Number K212945

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FLL 2022-03-01

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)

Applicant Microlife Intellectual Property GmbH

K-Number K211776

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NUC 2022-03-01

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

Applicant Rb Health (Us)

K-Number K213400

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PHC 2022-03-01

Vigilant Software Suite Vigilant Master Med

Applicant Fresenius Kabi AG

K-Number K210075

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MUE 2022-03-01

Digimamo D

Applicant Vmi Tecnologias Ltda

K-Number K210151

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NKB 2022-02-28

VyLink Spinal Screw System

Applicant Vy Spine, LLC

K-Number K213750

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LZA 2022-02-28

Disposable Nitrile Examination Gloves

Applicant Chifeng Huawei Medical Science&Technology Co., Ltd.

K-Number K212833

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PNR 2022-02-28

ENFit enteral syringes (NUTRIFIT)

Applicant Pentaferte Italia S.R.L.

K-Number K211661

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EOQ 2022-02-28

Vathin Video Bronchoscope System

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K213635

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NBW 2022-02-26

CardioChek Plus Test System; CardioChek Plus Home Test System

Applicant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K-Number K193406

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IPF 2022-02-25

Levator Elite (Model LE9011)

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K213043

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