BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMARTWAVE IF 2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    EFILM VIDEO

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERCISE CARTESIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 11, 2024

    UNKNOWN NEXGEN KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 1, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 16, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 2011

    GRYPHON ORTHOCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·April 28, 2026

    GRYPHON ORTHOCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·April 10, 2026

    GRYPHON ORTHOCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·March 31, 2026

    MANTIS REDUX BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

    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