BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    BI-MENTUM™ ALTRX® Dual Mobility Liner

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Symmetry Humby

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482058039·Symmetry® Hook, Humby Swivel Skin, 4 1/2 in

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981197452·Smooth Shank Poly. Screw, 3.5mm x 32mm

    AUTOREADER 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HARDY DISK, CEFPODOXINE, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Gibralt®

    FDA UDI
    INNO Holdings, Inc.·M711050002035320·Posterior Cervical Screw Assembly, 3.5mm X 32mm...

    Gibralt

    FDA UDI
    Choice Spine, LP·10885862247544·

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 28, 2020

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 2, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 27, 2014

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013

    VASSALLO GT

    FDA Adverse Event
    Injury ·FILMECC CO., LTD.·Product code DQX·October 3, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 26, 2024

    GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Recall
    Terminated ·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·November 26, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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