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

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    CAPHOSOL

    FDA 510(k)
    FDA Unclassified ·Unknown

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159501·PROTECT.EPI ELBOW SUPPORT GRAY II

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308020·Access Sleeve Handle

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380020·Handle, Ratcheting In Line Cannulated, Impact

    TEGO CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·October 19, 2020

    HYSTEROSCOPES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPIRAL IMAGING OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMAX2PLUS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 4, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·April 17, 2008

    PLUM LS PRIM. 225 CM CLAVE PORT DISTA

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017

    ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English language version for the blind or visually impaired, Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·June 22, 2006

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    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