BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LCP

    FDA UDI
    Synthes GmbH·10886982168443·LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR ...

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)

    TRANSPAC MONITORING KIT

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DRS·September 8, 2016

    PS MEDICAL STRATA II VALVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aquilion ONE Vision, v7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·September 21, 2012

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 11, 2014

    CHILI PUMP AND TUBING

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LPB·April 8, 2013

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    TRANSPAC MONITORING KIT

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DRS·September 8, 2016

    TMC SPEEDMTP

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025

    PKG, FUNDUS FORCEPS, P/N 0250080315. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024