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

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    EDI BZO Uncut Sheet - Cup*, Item No. 160170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·January 15, 2003

    Invacare 2G Tarsys Seating System, Model 2GR.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Invacare 2G Tarsys Seating System, Model 2GT.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Invacare 2G Tarsys Seating System, Model 2GTR.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Datex-Ohmeda S/5 Anesthesia Delivery Units

    FDA Recall
    Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code BSZ·July 15, 2003

    Quantum TTC Biliary Balloon Dilator

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code KNQ·September 15, 2003

    Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135

    FDA Recall
    Terminated ·Product code FGE·April 15, 2003

    Intralase FS Laser System. Laser Keratome

    FDA Recall
    Terminated ·Product code GEX·July 15, 2003

    Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 15, 2003

    PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JOH·December 12, 2003

    Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 15, 2003

    Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 15, 2003

    Datex-Ohmeda Cardiocap/5 Patient Monitors

    FDA Recall
    Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code MHX·October 17, 2003

    Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·June 16, 2003

    Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 1/4 inches in length. Catalog # 281-01-08.

    FDA Recall
    Terminated ·Zimmer Inc·Product code JDW·October 15, 2003