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

EOQ 2021-08-09

EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

Applicant Boston Scientific Corporation

K-Number K211030

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LZA 2021-08-09

Edma Synthetic Nitrile Examination Gloves

Applicant Edma Group, LLC

K-Number K211540

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IYN 2021-08-09

X-CUBE 90

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K211300

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LYZ 2021-08-08

Disposable Synthetic Vinyl Nitrile Examination Glove

Applicant Jiangsu Cureguard Glove Co., Ltd.

K-Number K211354

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HWC 2021-08-06

PAO Cortical Screw

Applicant Medacta International S.A.

K-Number K211435

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GWG 2021-08-06

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes

Applicant Stryker

K-Number K211202

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KPS 2021-08-06

Vereos PET/CT

Applicant Philips Medical Systems Nederland B.V.

K-Number K211764

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LZA 2021-08-06

Nitrile Patient Examination Glove

Applicant Pingan Medical Products Co., Ltd.

K-Number K210725

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NHA 2021-08-06

Kisses Plus Implant System

Applicant Achimhai Medical Corporation

K-Number K200193

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HWC 2021-08-06

TriMed Threaded Intramedullary Nail System

Applicant TriMed, Inc.

K-Number K211783

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IZQ 2021-08-06

ulrichINJECT CT motion

Applicant Ulrich GmbH & Co. KG

K-Number K210541

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NOE 2021-08-06

Diazyme PLAC® Test for Lp-PLA2 Activity

Applicant Diazyme Laboratories, Inc.

K-Number K203136

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