BEUDAMED
    60 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·March 25, 2026

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK, Model Number DYNJ67990; i) CLOSURE PACK, Model Number DYNJ83054A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    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