BEUDAMED
    24 results · 25ms · Sources: EU EUDAMED, US FDA

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    CLICKLINE Scissor Insert for Single Use

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

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304007437·

    Oticon

    FDA UDI
    Oticon A/S·05707131283757·H10V2, BTE 13 WL 100 TC

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099447·Procera Implant Bridge Ti Abut Level 2 unit

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103874·T³ Acetabular Hemispherical Shell, No Hole, 44mm

    RETRIEVE IMPLANT CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    ARCTEC SEMIRIGID PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PASSEO-18 5/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    PASSEO-18 6/200/90

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    PASSEO-18 2.5/170/130

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·June 6, 2013

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 6, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    Biograph mMR. Model Number: 10433372.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025