BEUDAMED
    17 results · 7ms · 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

    MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK MINI 1HH-1HM- 1FM, REF: 169-102; BD PYXIS MEDBANK MINI 1HH-3HM, REF: 169-103; BD PYXIS MEDBANK MINI 2FH, REF: 169-104; BD PYXIS MEDBANK MINI 2FM, REF: 169-105; BD PYXIS MEDBANK MINI 2HH-1FH, REF: 169-106; BD PYXIS MEDBANK MINI 2HH-1FM , REF: 169-107; BD PYXIS MEDBANK MINI 2HH-2HM, REF: 169-108; BD PYXIS MEDBANK MINI 2HM-1FM, REF: 169-109; BD PYXIS MEDBANK MINI 3HH-1FG, REF: 169-110; BD PYXIS MEDBANK MINI 3HH-1HM, REF: 169-111; BD PYXIS MEDBANK MINI 4HH, REF: 169-112; BD PYXIS MEDBANK MINI 4HM, REF: 169-113; BD PYXIS MDBANK TWR MN 7HH-1HM-3FM RxNow, REF: 169-132; BD PYXIS MEDBANK MINI 1FH-1FM, REF: 169-137; BD PYXIS MEDBANK TWR MN 1FH- 10HM-1FM, REF: 169-138; BD PYXIS MEDBANK TWR MN 2HH- 4FH-2FM, REF: 169-139; OBS BD PYXIS MB TOWER MAIN, REF: 169-153; OBS BD PYXIS MB TWR RXNOW MAIN W/MED PRI, REF: 169-155; OBS BD PYXIS MB TWR RXNOW MAIN W/PAT PRI, REF: 169-156; OBS BD PYXIS MB MINI MAIN W/CUBIE DRWS, REF: 169-159; OBS BD PYXIS MB MINI MAIN W/MATRIX DRWS, REF: 169-160; OBS BD PYXIS MB MINI MAIN W/HH FALSE DRW, REF: 169-161; OBS BD PYXIS MB MINI MAIN W/FH FALSE DRW, REF: 169-162; BD PYXIS MEDBANK TWR MN 10HH- 1FH-1FM, REF: 169-23; BD PYXIS MEDBANK TWR MN 10HH- 2FH, REF: 169-24; BD PYXIS MEDBANK TWR MN 10HH- 2FM, REF: 169-25; BD PYXIS MEDBANK TWR MN 12HH- 1FF, REF: 169-26; BD PYXIS MEDBANK TWR MN 12HH- 1FH, REF: 169-27; BD PYXIS MEDBANK TWR MN 12HH- 1FM, REF: 169-28; BD PYXIS MEDBANK TWR MN 14HH, REF: 169-29; BD PYXIS MEDBANK TWR MN 1HH- 1HM-2FM-4FF, REF: 169-30; BD PYXIS MEDBANK TWR MN 2FH- 2HM-4FM, REF: 169-31; BD PYXIS MEDBANK TWR MN 2HH- 10HM-1FM, REF: 169-32; BD PYXIS MEDBANK TWR MN 2HH- 1FH-5FM, REF: 169-33; BD PYXIS MEDBANK TWR MN 2HH- 2FH-4FM, REF: 169-34; BD PYXIS MEDBANK TWR MN 2HH- 2FM-4FF, REF: 169-35; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FF, REF: 169-36; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FM, REF: 169-37; BD PYXIS MEDBANK TWR MN 2HH- 6FM, REF: 169-38; BD PYXIS MEDBANK TWR MN 2HH- 6HM-3FM, REF: 169-39; BD PYXIS MEDBANK TWR MN 2HH- 8HM-2FM, REF: 169-40; BD PYXIS MEDBANK TWR MN 2HM- 6FM, REF: 169-41; BD PYXIS MEDBANK TWR MN 3FH-4FM , REF: 169-42; BD PYXIS MEDBANK TWR MN 3HH- 7HM-2FM, REF: 169-43; BD PYXIS MEDBANK TWR MN 4HH- 10HM, REF: 169-44; BD PYXIS MEDBANK TWR MN 4HH- 1FH-2HM-3FM, REF: 169-45; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4FM, REF: 169-46; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4HM-2FM, REF: 169-47; BD PYXIS MEDBANK TWR MN 4HH- 1FH-6HM-1FM, REF: 169-48; BD PYXIS MEDBANK TWR MN 4HH- 2FH-2HM-2FM, REF: 169-49; BD PYXIS MEDBANK TWR MN 4HH- 2FH-3FM, REF: 169-50; BD PYXIS MEDBANK TWR MN 4HH- 2HM-4FM, REF: 169-51; BD PYXIS MEDBANK TWR MN 4HH- 3FH-2FM, REF: 169-52; BD PYXIS MEDBANK TWR MN 4HH- 4FH-1FM, REF: 169-53; BD PYXIS MEDBANK TWR MN 4HH- 4HM-3FM, REF: 169-54; BD PYXIS MEDBANK TWR MN 4HH-5FH, REF: 169-55; BD PYXIS MEDBANK TWR MN 4HH- 5FM, REF: 169-56; BD PYXIS MEDBANK TWR MN 4HH- 6HM-2FM, REF: 169-57; BD PYXIS MEDBANK TWR MN 4HH- 8HM-1FM, REF: 169-58; BD PYXIS MEDBANK TWR MN 4HM- 5FM, REF: 169-59; BD PYXIS MEDBANK TWR MN 5HH- 3HM-3FM, REF: 169-60; BD PYXIS MEDBANK TWR MN 5HH- 9HM, REF: 169-61; BD PYXIS MEDBANK TWR MN 6FH-1FM, REF: 169-62; BD PYXIS MEDBANK TWR MN 6HH- 1FH-2HM-2FM, REF: 169-63; BD PYXIS MEDBANK TWR MN 6HH- 1FH-3FM, REF: 169-64; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2FM, REF: 169-65; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2HM-1FM, REF: 169-66; BD PYXIS MEDBANK TWR MN 6HH-4FH, REF: 169-67; BD PYXIS MEDBANK TWR MN 6HH- 4FM, REF: 169-68; BD PYXIS MEDBANK TWR MN 6HH- 4HM-2FM, REF: 169-69; BD PYXIS MEDBANK TWR MN 6HH- 6HM-1FM, REF: 169-70; BD PYXIS MEDBANK TWR MN 6HH- 8HM, REF: 169-71; BD PYXIS MEDBANK TWR MN 7FH, REF: 169-72; BD PYXIS M

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·April 23, 2025

    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

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES SARS-CoV-2 Assay

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 24, 2022

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·November 2, 2022

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·March 26, 2025

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·November 6, 2024

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·April 26, 2023

    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·July 12, 2023

    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Enforcement
    Class II ·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025

    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

    FDA Enforcement
    Class II ·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023