BEUDAMED
    621 results · 23ms · Sources: EU EUDAMED, US FDA

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    Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DKJ·June 29, 2017

    ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023

    Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica CH Analyzer Siemens Material Number (SMN): 11099440

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code MKJ·September 16, 2014

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code MKJ·September 16, 2014

    BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code MKJ·September 16, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code MKJ·August 26, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code MKJ·September 16, 2014

    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

    BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

    BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code MKJ·August 26, 2014

    Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·June 3, 2016