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

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    INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JABES ELECTRONIC STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMERALD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·January 2, 2018

    AUTOGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 1, 2014

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 10, 2013

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015