BEUDAMED
    37 results · 6ms · Sources: EU EUDAMED, US FDA

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

    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·September 6, 2023

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·September 6, 2023

    Convenience Kit, BREAST HERNIA DYNJ909125G

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

    FDA Enforcement
    Class I ·Ongoing·Omnicell, Inc.·May 20, 2026

    CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp.·December 20, 2023

    Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

    FDA Enforcement
    Class I ·Ongoing·Navajo Manufacturing Company·April 1, 2026

    Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·January 25, 2023

    Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.

    FDA Enforcement
    Class I ·Ongoing·Datascope Corp.·December 22, 2021

    Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024