BEUDAMED
    17 results · 39ms · Sources: EU EUDAMED, US FDA

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    EMS 400

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Pregnancy Combo Cassette Test

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918000108·HCG Combo Cassette Test

    DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD 50ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMF·March 24, 2025

    BD SMARTSITE BAG ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BD SWITZERLAND SARL·Product code LHI·March 24, 2025

    BD 10ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMF·March 24, 2025

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTP·March 20, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 15, 2011

    ELECSYS 1010

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 31, 2008

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·June 6, 2019

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025