311 results
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15ms
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Sources: EU EUDAMED, US FDA
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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
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 Enforcement
Class II
·Terminated·Bio-Detek, Inc.·October 15, 2014
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 Enforcement
Class II
·Terminated·Bio-Detek, Inc.·October 15, 2014
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·May 2, 2018
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 Enforcement
Class II
·Terminated·Bio-Detek, Inc.·October 15, 2014
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 Enforcement
Class II
·Terminated·Bio-Detek, Inc.·October 15, 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 Enforcement
Class II
·Terminated·Bio-Detek, Inc.·September 24, 2014
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 26, 2017
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·May 2, 2018
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·May 2, 2018
Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T-22800 Material: 701049506
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
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 Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 26, 2017
Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 4901 Material: 701050839
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019