BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICASEPT DUVAL LUNG GRASPER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896008038·MICASEPT DUVAL LUNG GRASPER WITH HEGAR RATCHET

    MICASEPT DUVAL LUNG GRASPER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09920919020·MICASEPT DUVAL LUNG GRASPER WITH HEGAR RATCHET

    MICASEPT DUVAL LUNG GRASPER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896010932·MICASEPT DUVAL LUNG GRASPER WITH HEGAR RATCHET

    BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

    PASSPORT XG MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 27, 2014

    XENIUM XPH

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION *USD*·Product code KDI·May 18, 2011

    Microdot Xtra blood glucose test strips

    FDA Enforcement
    Class II ·Ongoing·Cambridge Sensors Limited·August 28, 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