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

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    ALTRUA 2 SR Pacemaker

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·January 24, 2018

    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

    FDA Enforcement
    Class II ·Terminated·BSN Medical Inc·June 15, 2022

    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.

    FDA Enforcement
    Class II ·Terminated·Sr Instruments Inc·April 24, 2013