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

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    SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Biomeme RNA Process Control (RPC) Kiit

    FDA UDI
    Biomeme, Inc.·00810096640079·RNA Process Control for Biomeme's SARS-CoV-2 as...

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741126383·Catheter Placement Kit

    Ponsky Deluxe PEG Kit

    FDA UDI
    Bard Access Systems, Inc.·00801741081071·DELUXE PULL PEG

    UMT-110 Mobile Trolley

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904085593·

    Hyperinflation

    FDA UDI
    WESTMED, INC.·05707480137503·Hyperinflation System, 1/2L Bag (not made with ...

    UMT-110 Mobile Trolley

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904000282·

    INSUFFLATION NEEDLE, MODEL R65-933

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2022

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·March 12, 2013

    VIRTUOSO II DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 11, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 24, 2011

    ZUMA Z2 7F GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC·Product code DQY·June 12, 2020

    Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, REF 000627, 20F.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    BrightView SPECT (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

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017