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

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    BELMONT BUDDY FLUID WARMER

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020

    HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013

    EPIDURAL CATHETERIZATION COMP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code CAZ·May 22, 2008

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·April 8, 2011

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024

    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

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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