BEUDAMED
    44 results · 13ms · Sources: EU EUDAMED, US FDA

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    Change Healthcare Radiology Solutions software version 14.2.2

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code LLZ·August 13, 2025

    smiths medical Medfusion Model 4000 syringe pump

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Recall
    Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

    GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes

    FDA Recall
    Open, Classified ·W.L. Gore & Associates, Inc.·Product code FGE·January 19, 2024

    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

    FDA Recall
    Open, Classified ·W.L. Gore & Associates, Inc.·Product code FTL·July 3, 2024

    GORE CARDIOFORM ASD Occluder. cardiovascular implant.

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code MLV·September 21, 2022

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    FDA Recall
    Open, Classified ·W. L. Gore & Associates Inc.·Product code MJN·July 12, 2021

    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code DSY·May 12, 2021

    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code PRL·September 7, 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

    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code DSY·August 26, 2025

    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code PRL·July 1, 2024

    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

    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 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

    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

    FDA Recall
    Open, Classified ·W L Gore & Associates, Inc.·Product code DSY·May 12, 2021