BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743571·LEVAMED ANKLE SUPPORT SILVER VI

    D-SPECT VISTA

    FDA UDI
    SPECTRUM DYNAMICS MEDICAL, INC·07290108670134·Single Photon Emission Computed Tomography Syst...

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·April 30, 2025

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023994·PADDLE SPREADER, 16MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102060·Shaver, Open, 6mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023895·PADDLE SPREADER, 6MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102160·Shaver, Open 16mm

    YPSOPUMP INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·April 4, 2025

    YPSOPUMP INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 17, 2025

    VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    M-SERIES DC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    SERVICE, CCU, HIGH DEF, 560P, 2NDGEN

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 12, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 11, 2011

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014