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

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    NEUROMETRIX BIOAMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Neurology

    CODMAN BACTISEAL CATHETERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    HAC-420 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOSPITAL NON-VENTED FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017

    ELECTROSURGICAL COAGULATION FOR AESTHETIC

    FDA Adverse Event
    Injury ·F CARE SYSTEMS USA LLC·Product code ONQ·November 22, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·April 29, 2013

    CARTO¿ 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·May 10, 2011

    COLLEAGUE PUMP CE ENGLISH VERSION

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE PTE. LTD·Product code FRN·July 28, 2008

    VANGUARD FEMORAL POSTERIOR AUGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018

    VANGUARD FEMORAL POSTERIOR AUGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018

    VANGUARD FEMORAL DISTAL AUGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2018

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024