BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

    FDA 510(k)
    FDA Class 2 ·Immunology

    HEMOCLEAN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    GYNNIE OB-GYN STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 17, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 21, 2011

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC.·Product code NQO·June 18, 2008

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·July 26, 2016

    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·April 15, 2015

    AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

    FDA Enforcement
    Class II ·Terminated·Primus Medical LLC·November 14, 2012

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015