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

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    NUVASIVE LONG LATERAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PowerGlide Midline Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741038150·PowerGlide Midline Catheter 22G, 8cm with Full ...

    Peripheral Catheter Insertion Kit

    FDA UDI
    Bard Access Systems, Inc.·00801741110597·DOT PFlex, 22G 8cm Full

    36M - Class B 21 Kent - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620817·36M - Class B 21 Kent - Metal

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    ENDOSCOPIC CLIP SYSTEM

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

    NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 9, 2025

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MPB·February 13, 2017

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH. LTD. / HUNTINGTON·Product code HQL·May 16, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 19, 2014

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 13, 2011

    SAFESHEATH II 9F

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014