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

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    LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Liberty® Select Cycler

    FDA UDI
    Fresenius Medical Care Holdings, Inc.·00840861102068·Liberty® Select Cycler

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304479425·

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868239700·

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    PAP-CAP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP

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

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

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    FDA Adverse Event
    BIOMET MICROFIXATION·Product code EJL·September 30, 2008

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Recall
    Completed ·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Enforcement
    Class II ·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

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

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022