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

IMK 2021-06-16

iBOT Personal Mobility Device (iBOT PMD)

Applicant Mobius Mobility

K-Number K210920

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LIT 2021-06-16

Sublime Radial Access 018 RX Dilatation Catheter

Applicant Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,

K-Number K211044

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FXX 2021-06-16

Disposable Medical Surgical Face Mask

Applicant Guangdong Haiou Medical Apparatus Co., Ltd.

K-Number K203200

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LLZ 2021-06-16

Qmenta Care Platform Family

Applicant Mint Labs, Inc., D/B/A. Qmenta

K-Number K202718

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OLZ 2021-06-16

EnsoSleep

Applicant Ensodata, Inc.

K-Number K210034

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MVM 2021-06-16

Aptiva Celiac Disease IgA Reagent

Applicant Inova Diagnostics, Inc.

K-Number K193604

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MAX 2021-06-15

SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers

Applicant Camber Spine Technologies, LLC

K-Number K210595

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NFJ 2021-06-15

CellChek 20 rc

Applicant Konan Medical, Inc.

K-Number K203244

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FXX 2021-06-15

Amerishield Surgical Mask

Applicant Premiumestore, LLC

K-Number K211520

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FFK 2021-06-14

URO-TOUCH 9 French Probe

Applicant Northgate Technologies, Inc.

K-Number K202813

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NUC 2021-06-14

Coconu Water Based Personal Lubricant

Applicant Coconu, LLC

K-Number K210814

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HKY 2021-06-14

CATS®-D Tonometer Prism

Applicant Cats Tonometer, LLC

K-Number K203850

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