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

NAY 2022-02-17

da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System

Applicant Intuitive Surgical, Inc.

K-Number K213710

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LBH 2022-02-16

Apapro Desensitizer

Applicant Sangi Co., Ltd.

K-Number K220419

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MAX 2022-02-16

LumiVy Lumbar IBF System

Applicant Vy Spine, LLC

K-Number K212930

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HRS 2022-02-16

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K220136

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FAD 2022-02-16

NovoFlow Reinforced Ureteral Stent

Applicant Coloplast Corp.

K-Number K213186

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IRP 2022-02-16

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

Applicant Bio Compression Systems, Inc.

K-Number K213533

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EOQ 2022-02-16

Broncoflex Agile, Broncoflex Vortex, Screeni

Applicant Axess Vision Technology

K-Number K212886

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MQB 2022-02-16

14HQ901G-B

Applicant Lg Electronics.Inc

K-Number K214044

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KWQ 2022-02-16

Aspiron S ACP System

Applicant U&I Corporation

K-Number K220147

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MEG 2022-02-15

Sterile Auto-Disable Syringes with/without Needle for Single Use

Applicant Zhejiang Kangkang Medical-Devices Co., Ltd.

K-Number K210229

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QFG 2022-02-15

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

Applicant Tandem Diabetes Care, Inc.

K-Number K203234

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LRK 2022-02-15

Morpheus

Applicant S4S UK , Ltd.

K-Number K210636

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