BEUDAMED
    21 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMIT TOBRAMYCIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NBAC 1.5T SMS, Flex

    FDA UDI
    LMT Medical Systems GmbH·04260486610230·No description.

    eZ-Fix

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731111432·Rail, Mono 150mm Blue

    ACUMED

    FDA UDI
    Acumed LLC·10806378040276·Acu-Loc® Dorsal T-Guide Std, Left

    AdexusDx hCG Test

    FDA UDI
    NOWDIAGNOSTICS, INC.·00858022006216·Box of 50 cartridges/tests

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306809606·Toomey to Toomey Transfer

    eZ-Fix

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132142820·Rail, Mono 150mm Blue

    Electrode

    FDA UDI
    SOPRO-COMEG GmbH·04059082009759·

    Cystoscopy adaptor

    FDA UDI
    SOPRO-COMEG GmbH·04059082030470·

    Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CERAMICS2IN1

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 5, 2018

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 7, 2021

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·October 17, 2012

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·August 10, 2010

    OXF UNI TIB TRAY SZ E LM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·October 24, 2023

    OXF ANAT BRG LT LG SIZE 4 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·October 24, 2023

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·December 20, 2023

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021