BEUDAMED
    36 results · 20ms · Sources: EU EUDAMED, US FDA

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    SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ITL Essential Standard Quiver

    FDA UDI
    ITL ASIA PACIFIC SDN. BHD.·19555240401141·Standard quiver, PVC loop, polypropylene, indiv...

    Bur PM2-70 80K Carb Ø2.7 St

    FDA UDI
    Bien-Air Surgery SA·17630055503623·

    Osstell SmartPeg Type 18

    FDA UDI
    Osstell AB·09010522001325·ISQ Measurement Peg

    Tongue-Away Sheild

    FDA UDI
    TP ORTHODONTICS INC·00192029049457·Small, Medium, Large

    SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REFURB LEEP PRECISION GEN

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·June 2, 2023

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 8, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2011

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code BSP·December 8, 2020

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·December 23, 2020

    Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·May 13, 2020

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014