BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210516500·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FERRITIN GENERATION 2

    FDA 510(k)
    FDA Class 2 ·Immunology

    FIBERTAPE CERCLAGE TENSIONER, REUSABLE

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·April 26, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 4, 2025

    CERCLAGE TENSIONER RATCHETING HANDLE

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·April 22, 2024

    FIBERTAPE CERCLAGE SUTURE

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code JDQ·March 29, 2021

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 10, 2013

    KAPPA 700 SR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·April 12, 2011

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 21, 2008

    Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    TIGERTAPE STERNAL CLOSURE W/ BLUNT NDL

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code JDQ·September 13, 2023

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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