BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    ELECTROLY TE CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING

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

    JELCO HYPODERMIC NEEDLE WITH NEEDLE-PRO SAFETY DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.,·Product code FMI·February 26, 2016

    JELCO HYPODERMIC NEEDLE WITH NEEDLE-PRO SAFETY DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.,·Product code FMI·February 26, 2016

    SLIMLINE SEMI-REGID FORCEPS

    FDA Adverse Event
    Malfunction ·GYRUS ACMI INC·Product code HIN·February 21, 2014

    MOBICATH STEERABLE SHEATH

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DYB·October 19, 2012

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 28, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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