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

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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LYZ 2022-02-14

Vinyl Powder Free Examination Glove

Applicant Top Glove Vietnam Company Limited

K-Number K212011

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DRF 2022-02-14

RithmID-SD Steerable Diagnostic Electrophysiology Catheter

Applicant Synaptic Medical Corporation

K-Number K203793

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GZI 2022-02-14

Cionic Neural Sleeve NS-100

Applicant Cionic

K-Number K213622

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FDS 2022-02-14

EvoEndo Single-Use Endoscopy System

Applicant EvoEndo, Inc.

K-Number K213606

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