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

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    MICRO-SUGICAL POWER INSTRUMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707062448·TUBE MIM 22/51 L

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277114396·Nordt Micro Fracture Angled Osteotome

    Reprocessed 3.5mm Surgibit Drill, Lag

    FDA UDI
    SURETEK MEDICAL·B3908025031·

    FacetLINK MI

    FDA UDI
    LINKSPINE, INC.·00817329024484·Dilator 3

    ACUMED

    FDA UDI
    Acumed LLC·10806378096310·3.5mm QR Drill, Lag

    Acumed

    FDA UDI
    Provision·B504OM8025030·

    2.8MM / 3.5MM DRILL GUIDE

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code LXH·February 2, 2023

    2.8MM / 3.5MM THIN DRILL GUIDE

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code LXH·February 2, 2023

    3.5MM QR DRILL, LAG

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code HTW·February 2, 2023

    DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

    FDA 510(k)
    FDA Class 2 ·Immunology

    FETALGARD LITE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SIDEKICK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code LRK·October 19, 2012

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 17, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

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