BEUDAMED
    3 results · 21ms · 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 Status: Terminated ×

    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·August 3, 2016

    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code KTN·June 22, 2016

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014