BEUDAMED
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    Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code MQH·December 17, 2007

    Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code MQH·March 2, 2008

    Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes.

    FDA Recall
    Terminated ·Cook Vascular Inc.·Product code MQH·March 2, 2008

    ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQH·March 27, 2019

    CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·June 24, 2021

    CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·May 12, 2021

    CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·May 12, 2021

    CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·May 12, 2021

    CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·October 24, 2023

    CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·October 24, 2023

    LICOX temperature probe, Model C8.B

    FDA Recall
    Terminated ·Integra Neuro Sciences·Product code GMW·January 21, 2005

    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·May 12, 2021

    LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

    FDA Recall
    Terminated ·Integra Neuro Sciences·Product code GMW·January 21, 2005

    cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports the following parameters: RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, %NRBC, #NRBC, WBC, %NEUT, #NEUT, %LYMPH, #LYMPH, %MONO, #MONO, %EO, #EO, %BASO, #BASO, PLT, MPV, %RET, #RET, HGB-RET.

    FDA Recall
    Terminated ·Roche Diagnostics Hematology·Product code JOY·May 7, 2018

    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    FDA Recall
    Terminated ·Product code GKZ·December 18, 2014

    CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·October 19, 2023

    CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·October 19, 2023

    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue catheter has not been studied.

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code FOZ·March 11, 2026

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·June 11, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·June 11, 2013