BEUDAMED
    24 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    FDA Enforcement
    Class II ·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·July 24, 2024

    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA, Inc·August 16, 2023

    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

    FDA Enforcement
    Class II ·Ongoing·Omnia Medical·September 17, 2025

    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,

    FDA Enforcement
    Class II ·Ongoing·Alphatec Spine, Inc.·September 6, 2023

    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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·October 8, 2025

    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 4, 2020

    GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 4, 2020

    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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021

    GORE CARDIOFORM Septal Occluder, REF: GSX0030A

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·February 8, 2023

    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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·August 25, 2021

    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 Enforcement
    Class II ·Ongoing·W. L. Gore & Associates Inc.·September 1, 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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021

    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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·October 20, 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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·August 25, 2021

    GORE CARDIOFORM ASD Occluder. cardiovascular implant.

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 2, 2022

    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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 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 Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021