BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2

    FDA 510(k)
    FDA Class 2 ·Radiology

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 21, 2023

    MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTO*THERM 395, MODEL ME 395

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 3, 2013

    HEARTSTART SLA BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DQA·September 8, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015