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

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    IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HairCheck-DT (THC)

    FDA UDI
    Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741028915·Catheter Placement Kit

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832024674·HUMERAL HEAD TRIAL

    NEW METAL STRIPS

    FDA UDI
    Gc America Inc.·14548161391672·NEW METAL STRIPS, Refill Package, #300 Mesh B-...

    NEW METAL STRIPS

    FDA UDI
    Gc America Inc.·D0470002571·NEW METAL STRIPS, Refill Package, #300 Mesh B-...

    Bard Button Device Bolus Device Bolus Feeding Tube with Straight Adaptor

    FDA UDI
    Bard Access Systems, Inc.·00801741080838·Bolus Tube for 18 Fr

    LIFEPAK 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873870549·LP15 ACCRY SHIPKIT,AHA,S

    POROCOAT PRODIGY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RADIONICS LUMBOPERITONEAL SHUNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·Product code FPA·May 11, 2024

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·March 12, 2013

    EZ-PRO R4 AMBUL COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 18, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·February 14, 2008

    PRODIGY LG STAT SHT LT 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016

    AUTOMATED IMPELLA CONTROLLER

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·April 25, 2025

    PRODIGY LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018

    AUTOMATED IMPELLA CONTROLLER

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·May 12, 2025

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012