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

KLE 2022-08-09

DenMat Glutaraldehyde Desensitizer

Applicant Denmat Holding, LLC

K-Number K222357

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QBD 2022-08-08

Dasky Disposable Sampling Tube (Model name: VSM02)

Applicant Ningbo Dasky Life Science Co., Ltd.

K-Number K211675

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LON 2022-08-08

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

Applicant bioMerieux, Inc.

K-Number K212243

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MOS 2022-08-08

dS Sentinelle Breast 16ch 1.5T Coil

Applicant Invivo Corporation (Business Trade Name: Philips)

K-Number K213735

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QIH 2022-08-08

ClearPoint Maestro Brain Model

Applicant ClearPoint Neuro, Inc.

K-Number K213645

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MOS 2022-08-08

dS Sentinelle Breast 16ch 3.0T Coil

Applicant Invivo Corporation (Business Trade Name: Philips)

K-Number K213727

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ELW 2022-08-08

Dental Impression Material

Applicant Chemoment Materials Co.,Ltd

K-Number K221668

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LLZ 2022-08-08

Dolphin Imaging 12.0

Applicant Patterson Dental Supply, Inc.

K-Number K222072

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LZA 2022-08-06

Pro Guard Nitrile Powder Free Examination Glove

Applicant Medical Glove Co., Ltd.

K-Number K213934

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NLH 2022-08-06

Reprocesses Umbilical Cable

Applicant Innovative Health, LLC

K-Number K221854

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OVE 2022-08-05

Unispace SA Cervical Cage

Applicant Edisoninno Co., Ltd.

K-Number K213791

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LPL 2022-08-05

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Applicant Dk Medivision Co., Ltd.

K-Number K220045

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