BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809848465·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    Arx

    FDA UDI
    Life Spine, Inc.·00190837130558·

    Arx

    FDA UDI
    Life Spine, Inc.·00190837124458·

    METAL SCREW ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FETALGARD LITE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2025

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·May 22, 2008

    COOLCUT

    FDA Adverse Event
    Malfunction ·ARTHREX·Product code HWE·April 4, 2011

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    Pulmonary heart valve allograft, human tissue for transplantation.

    FDA Recall
    Terminated ·LifeNet·Product code MIE·December 19, 2002

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015