BEUDAMED
    28 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·June 4, 2014

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·April 17, 2013

    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·July 3, 2013

    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·April 24, 2019

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 26, 2014

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 19, 2014

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·May 14, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·January 29, 2014

    Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·January 29, 2014