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

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    1ST MTP PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGXO

    FDA UDI
    Oticon A/S·05707131262400·H100, RITE 312 WL CBE AGXO

    SPHINX LASER SYSTEMS

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

    US ENDOSCOPY CYTOLOGY BRUSH

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

    BITE PROOF BITE BLOCK

    FDA Adverse Event
    Malfunction ·B AND B MEDICAL TECHNOLOGIES·Product code JXL·May 9, 2012

    B&B MEDICAL TECHNOLOGIES

    FDA Adverse Event
    Other ·B&B MEDICAL TECHNOLOGIES, INC. / INTEGRA BIOTECHNICAL, LLC·Product code JAY·May 15, 2012

    6.5CM ADULT CRANI ATTACHMT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 29, 2013

    PROTECTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·October 7, 2015

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·December 14, 2021

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    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