BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

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

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828102773·GEN4 Direct Access

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828109970·GEN4 DIGITAL

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304229723·

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304198524·

    RINGLOC UNIVERSAL HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304219694·

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 29, 2022

    CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    XISCAN 6000 IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACESSA PROVU SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code HFG·July 5, 2023

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 9, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 26, 2011

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 11, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021