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

QKQ 2022-03-01

Dynamyx Digital Pathology Software

Applicant Inspirata, Inc.

K-Number K210811

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FMF 2022-03-01

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K-Number K210848

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MXK 2022-03-01

MYAH

Applicant Visia Imaging S.R.L.

K-Number K211868

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FRN 2022-03-01

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

Applicant Fresenius Kabi AG

K-Number K210074

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OUR 2022-03-01

Blue Topaz Sacroiliac Screw System

Applicant Osseus Fusion Systems, LLC

K-Number K213590

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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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