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

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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FPA 2021-11-10

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

Applicant Ivenix, Inc.

K-Number K213089

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LLZ 2021-11-10

inVisionOS

Applicant Precisionos Technology, Inc.

K-Number K210344

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GEI 2021-11-10

Reverso

Applicant Intelis Instruments , Ltd.

K-Number K212107

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KNW 2021-11-10

Disposable Automatic Core Biopsy Instrument

Applicant Suzhou Leapmed Healthcare Corporation

K-Number K212284

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PBF 2021-11-10

VSP® Orthopedics System

Applicant 3D Systems

K-Number K211244

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IYE 2021-11-10

AlignRT Plus

Applicant Vision Rt, Ltd.

K-Number K212583

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JOW 2021-11-10

Venen-trainer (Model: FM150, SFM90)

Applicant Shenzhen Pango Electronic Co., Ltd.

K-Number K203746

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