BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085022840·Clean Collection Vials 50 vials

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159024098·LEGACY Jacobson Titanium Micro Needle Holder

    UPSYLON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTO·September 7, 2022

    PROSTEC 125I BRANCHYTHERAPY SNAPSEED

    FDA 510(k)
    FDA Class 2 ·Radiology

    FIXATION STYLETS, MODELS 335-287 AND 335-288

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 4, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·Product code FPA·May 6, 2024

    DEXTRUS 4135

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·February 13, 2013

    EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011

    ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·February 28, 2008

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Inc.·December 12, 2018

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Inc.·December 19, 2018

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JPB·February 24, 2017

    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

    FDA Recall
    Terminated ·Helena Laboratories, Inc.·Product code JPB·April 20, 2016

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024