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

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    HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS

    FDA 510(k)
    FDA Class 2 ·Dental

    OPART, MODEL MRT-600

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUATERA 700 BIMANUAL I/A HANDPIECE SET

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

    DERMABOND 2

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code MPN·April 2, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

    AED

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·April 15, 2008

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM

    FDA Adverse Event
    Injury ·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    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

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013