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

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    Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    V. Mueller

    FDA UDI
    STERIS CORPORATION·10885403279249·V. Mueller DISPOSABLE BIPOLAR FORCEPS

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702253733·ELVAREX 2/THIGH HIGH/OPEN TOE-ELEPHANTIASIS-VER...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702850765·ELVAREX 2/MID THIGH HIGH/SLANT-CLOSED TOE-ELEPH...

    GORE EMBOLIC FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 31, 2023

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376668758·12mm CORE, NANOTEC BAN 14 x 35 mm 0°

    BELLATEK® ABUTMENT TSV 3.5MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

    ABUTMENT, PATIENT SPECIFIC, TITANIUM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    HYALGAN

    FDA Adverse Event
    Injury ·FIDIA FARMACEUTICI S.P.A. ABANO TERME (PD)·Product code MOZ·May 27, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·October 6, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 3, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 29, 2011

    Artis Q.zen floor, Model Number 10848353

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·March 28, 2018

    Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·April 18, 2022