BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 16, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 8, 2013

    FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS

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

    DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·April 26, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 26, 2012

    3.2MM TROCAR 232MM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code FZX·April 29, 2013

    THERMACHOICE III

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code MKN·April 22, 2011

    ONE TOUCH ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·July 24, 2008

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 18, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 5, 2020

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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