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

DXN 2019-09-11

CNAP Monitor

Applicant Cnsystems Medizintechnik GmbH

K-Number K183521

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EBG 2019-09-11

TurboTemp EZ

Applicant Zest Anchors, LLC

K-Number K191619

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PLV 2019-09-11

Neocis Guidance System (NGS)

Applicant Neocis, Inc.

K-Number K191605

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KWT 2019-09-11

Catalyst OrthoScience CSR Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K191811

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OMB 2019-09-11

Ceribell Pocket EEG Device

Applicant Ceribell, Inc.

K-Number K191301

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JAK 2019-09-10

AI-Rad Companion (Cardiovascular)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183268

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BZG 2019-09-10

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

Applicant Welch Allyn, Inc.

K-Number K191013

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HKI 2019-09-10

KOWA nonmyd 8

Applicant Kowa Company , Ltd.

K-Number K191945

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GEX 2019-09-10

Pioneer Elite Diode Laser

Applicant CAO Group, Inc.

K-Number K181602

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PEM 2019-09-10

BH Medical Dental Barrier Sleeves and Barrier Film

Applicant Bh Medical Products Co., Ltd.

K-Number K190484

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DRN 2019-09-10

External Counterpulsation System

Applicant Vamed Medical Instrument Co., Ltd.

K-Number K190683

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GEX 2019-09-10

Sterling Supreme Diode Laser

Applicant CAO Group, Inc.

K-Number K181614

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