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

DQK 2021-11-11

EnSite X EP System

Applicant ABBOTT MEDICAL

K-Number K213364

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LZA 2021-11-11

Nitrile Examination Glove (Powder free, Blue)

Applicant Jiangsu Jinlian Medical Technology Co., Ltd.

K-Number K212497

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DQD 2021-11-10

eKuore Pro 4T - REF EP0098

Applicant Chip Ideas Electronics S.L.

K-Number K212013

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GEX 2021-11-10

Diode laser therapy system

Applicant Beijing Unt Technology Co., Ltd.

K-Number K212978

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PMU 2021-11-10

More-Cell-System

Applicant Agency For Medical Innovations GmbH

K-Number K212659

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OTN 2021-11-10

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

Applicant Caldera Medical, Inc.

K-Number K211975

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LZA 2021-11-10

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Shandong Shangwei Medical Products Co., Ltd.

K-Number K210779

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LLZ 2021-11-10

RTapp

Applicant Segana, Inc.

K-Number K212887

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CBK 2021-11-10

LTV2 Series Ventilators

Applicant Vyaire Medical, Inc.

K-Number K201082

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DXJ 2021-11-10

ESSENZ Patient Monitor

Applicant Livanova Deutschland, GmbH

K-Number K212003

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QFM 2021-11-10

Lunit INSIGHT CXR Triage

Applicant Lunit, Inc.

K-Number K211733

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JWH 2021-11-10

Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System

Applicant Conformis, Inc.

K-Number K213389

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