BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Catheter and Glove Suction Kit

    FDA UDI
    C. R. Bard, Inc.·00801741050701·Catheter and Glove Suction Kit

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694033893·2.0mm 5 Hole Lozenge Curved Reduction Plate

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694047715·2.0 System 5 Hole Lozenge Curved Plate Sterile ...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981179670·Z-Rod, Dia. 6.0mm, Co-Cr, 110mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694033909·2.0mm 5 Hole Lozenge Curved Reduction Plate, 2p...

    ATRIUM CENTRILFX MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASY LOOP, MODEL EZL-01

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONE TOUCH BASIC ORIGINAL

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 11, 2002

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 15, 2002

    HS III PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 29, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·August 28, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 25, 2011

    PU-681RA

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·August 22, 2025

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·October 12, 2023

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORPORATION·Product code MVK·March 11, 2022

    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

    FDA Enforcement
    Class I ·Ongoing·North American Rescue LLC.·May 6, 2026

    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

    FDA Recall
    Open, Classified ·North American Rescue LLC.·Product code LRR·March 27, 2026

    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013