BEUDAMED
    72 results · 19ms · Sources: EU EUDAMED, US FDA

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    REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010

    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 2, 2021

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

    FDA Recall
    Terminated ·Reckitt Benckiser LLC·Product code MOL·August 6, 2018

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

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    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 Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013

    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 Recall
    Terminated ·Mar Cor Purification·Product code FIP·April 24, 2014

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Recall
    Terminated ·Mar-Med Co·Product code GAX·December 28, 2020