BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    CLEARGUARD HD END CAP

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

    NC Cementable Abutment

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600305781·

    LMA

    FDA UDI
    TELEFLEX INCORPORATED·15060112318754·LMA Fastrach™ ETT 6.0mm

    LMA

    FDA UDI
    TELEFLEX INCORPORATED·05060112310447·LMA Fastrach™ ETT 6.0mm

    Biogel

    FDA UDI
    Bosma Enterprises·10818634023572·Biogel Optifit Ortho Surgical 6.0 - 40 Pair/Box

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111090479·OP SCISS 6" STR SH/SH

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019315057205·

    Fine osteotomy Locking HA 4.5 Cortical Bone Screw - L60mm

    FDA UDI
    Laboratoires Bodycad Inc·00688346002867·Button Head Locking HA 4.5 Cortical Self Tappin...

    NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166619·Initia T3 Acetabular Hemispherical Shell, Multi...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106318·Porous Acetabular Cup System - Hemispherical Sh...

    MECTACER BIOLOX OPTION BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 4, 2016

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 21, 2013

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011

    Single Shot Epidural Tray Catalog 1292

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 5, 2021

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 10, 2013