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

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    8 CHANNEL CARDIAC PHASED ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496032045·MISS RELAX 70 SHEER, SIZE L, NERO, GRADUATED CO...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120320451·Cool diamond

    ihcDirect® WT1 Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596948·Clone R1012

    ihcDirect® WT1 Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596955·Clone R1012

    ihcDirect® WT1 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934925·Clone R1012

    ihcDirect® WT1 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934918·Clone R1012

    WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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

    HIGHGATE CURVED ROD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENCOR ENSPIRE BREAST BIOPSY SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·November 19, 2020

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013

    ACCU-CHEK ® INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·March 28, 2011

    V-GO (H-PATCH) 20 UNIT BASAL / VALERITA

    FDA Adverse Event
    Other ·VALERITAS, LLC·Product code LZG·April 18, 2008

    MAGIC3 GO 14 FR MALE COUDE CATHETER WITH SUREGRIP

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZD·September 19, 2018

    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

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024