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

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    DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964020627·The ENDO CARRY-ON Procedure Kit contains all of...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062586·Endoflex K-Files 25 mm

    HONIGUM

    FDA 510(k)
    FDA Class 2 ·Dental

    WATER PURIFIER

    FDA 510(k)
    FDA Class 1 ·Dental

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·March 13, 2013

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·December 30, 2021

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024