BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Medline Anti-Fog Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AMISTEM C CEMENTED STEM SIZE 4 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 15, 2016

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 8, 2013

    MONOJECT

    FDA Adverse Event
    Malfunction ·COVIDIEN KENDALL·Product code FMI·June 28, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

    3.5MM TI CANCELLOUS AXON(TM) SCREW 16MM THREAD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKG·February 9, 2023

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    FDA Recall
    Terminated ·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DYB·September 23, 2013

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    FDA Enforcement
    Class I ·Terminated·Baylis Medical Corp *·November 13, 2013

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022