BEUDAMED
    111 results · 10ms · Sources: EU EUDAMED, US FDA

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    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·January 14, 2015

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    FDA Enforcement
    Class II ·Terminated·Alto Development Corp·August 7, 2019

    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·November 24, 2014

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    FDA Recall
    Terminated ·Alto Development Corp·Product code LDF·June 21, 2019

    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016

    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016

    Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DDR·April 3, 2006

    Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DDR·April 3, 2006

    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015

    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015

    2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

    Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code HWB·March 19, 2018

    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code KTT·April 10, 2014

    Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HXX·May 4, 2018