BEUDAMED
    20 results · 65ms · Sources: EU EUDAMED, US FDA

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    BARRIER BRAND ULTRA PROTECTION SURGICAL GOWN, LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·August 9, 2002

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, EXTRA LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·May 21, 2003

    BARRIER EXTRA PROTECTION PLUS GOWN, EXTRA LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·May 21, 2003

    BARRIER EXTRA PROTECTION PLUS GOWN, LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·May 21, 2003

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·May 21, 2003

    BARRIER EXTRA PROTECTION PLUS GOWN, LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·May 21, 2003

    MEPILEX BORDER POST-OP AG DRESSING

    FDA Adverse Event
    Malfunction ·MOLNLYCKE HEALTH CARE, INC.·Product code FRO·March 18, 2020

    BARRIER BRAND EXTRA PROTECTION SURGICAL GOWN, LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYA·June 7, 2002

    BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA, EXTRA LARGE

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·April 23, 2002

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN

    FDA Adverse Event
    Other ·MOLNLYCKE HEALTH CARE, INC.·Product code FYE·August 31, 2001

    Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·July 20, 2007

    9x15" Medium Utility Positioner with Cover

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code OUW·July 26, 2017

    Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

    FDA Recall
    Open, Classified ·Molnlycke Health Care, Inc·Product code FZW·April 24, 2017

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019

    7x10" Small Utility Positioner with Cover

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code OUW·July 26, 2017

    Barrier Hip Sheet with Side Pockets

    FDA Recall
    Terminated ·Molnlycke Health Care Inc·Product code KKX·July 14, 2003

    9x15" Medium Utility Positioner with Cover

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·February 7, 2018

    7x10" Small Utility Positioner with Cover

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·February 7, 2018

    Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

    FDA Enforcement
    Class II ·Ongoing·Molnlycke Health Care, Inc·May 24, 2017

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019