BEUDAMED
    60 results · 18ms · 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

    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·October 29, 2025

    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

    FDA Enforcement
    Class II ·Ongoing·HeartSine Technologies Ltd·July 19, 2023

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Centurion FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Legion FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Constellation Procedure Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Infinity FMS Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    Alcon Custom Pak Surgical Procedure Pack

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·December 7, 2022

    GEM Premier 5000 PAK, Part No. 00055360004.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055360010.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055407504.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055360008.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055407511.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055407508.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055407510.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055360011.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    GEM Premier 5000 PAK; Part No. 00055415004.

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

    PIE PAK Models: P2HC-A, P2HC-S, P2HC

    FDA Enforcement
    Class II ·Ongoing·Edermy LLC·March 4, 2026