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

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    SOCON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040073490·Carbide Bur FG 170L

    QUATTRODE LEAD WIDE SPACED, 90 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·July 9, 2016

    EXTENSION, DUAL 4 CHANNEL 60CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·July 9, 2016

    IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

    FDA 510(k)
    FDA Class 2 ·Dental

    QUATTRODE LEAD WIDE SPACED, 90 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·July 9, 2016

    QUATTRODE LEAD WIDE SPACED, 90 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·July 9, 2016

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 6, 2025

    CORONAL ROD BENDER-RIGHT FOR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXW·February 28, 2013

    MEDTRONIC SYNCHROMED INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LKK·February 22, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 21, 2008

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·January 19, 2021

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 8, 2021

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018