BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    ENFit Disposable Enteral Syringe

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

    Kirschner wire

    FDA UDI
    ADLER ORTHO SPA·08054752863408·TIPLESS KIRSHNER WIRE D2mm L=150mm

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184483·Accufit Molar Bands Lower Right Second Molar 41

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113851·ARBISSER ANTERIOR CHAMBER CANNULA 30GA ANG 7MM

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036869·Trial Rasp, No Stop, Assembly, Lordotic, 10mm

    CONCENTRIC RETRIEVER, MODEL 90030

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FREESTYLE LIBRE 2 SENSOR

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code QBJ·May 20, 2024

    LIFECARE PCA WITH MEDNET

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 15, 2008

    SPRINT QUATTRO SECURE

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 2, 2013

    VERSA-DIAL 50X27X50 HUM HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·February 16, 2021

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 16, 2021

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    PERSONA HEX HEADED SCREW 3.5 MM HEX 27 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·April 10, 2025

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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