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

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    BIOLOX(R) DELTA CERAMIC HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sasmar Vanilla

    FDA UDI
    Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT

    TOPKIN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 29, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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