BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    ENZYME II CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814749·GENUMEDI EXTRA WIDE SAND SIZE VI

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520561·Split Tube Retractor, Size Ø18x80 mm

    SYNTHES SYNEX SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARPOINT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AGX

    FDA UDI
    Widex A/S·05706069749205·Audigy AGXWU-FP (Midnight black S-330 ) Telecoi...

    AGX

    FDA UDI
    Widex A/S·05706069748352·Audigy AGXWU-FM (Midnight black S-330 ) RC coil

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·May 10, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 18, 2011

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 4MM X 7CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021