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

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    ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

    FDA 510(k)
    FDA Unclassified ·Unknown

    Klitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

    OMNIA X/XS ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MED-LOGICS DISPOSABLE ALK TUBING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012

    PROFEMUR(R) HIP STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    S5 CONTROL PANEL

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 11, 2013

    SENSAR ACRYLIC IOL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·April 15, 2011

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·June 17, 2008

    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 2012

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022