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

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    COLONGLIDE(R) LUBRICANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SURGISTAR, INC.

    FDA UDI
    SURGISTAR, INC.·00878799002556·

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488229843·ULTRASOUND NERVE BLOCK PREP

    FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

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

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151592·Tesera-k SA, 31mm X 26mm X 17mm, 12° Lordosis, T3

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157266·Tesera-k ALIF, 31W X 26D, 17mm, 12° Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156511·Tesera-k ALIF, 31W X 26D, 17mm, 12° Trial

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 15, 2026

    MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 17, 2013

    CONCERTO II CRT-D

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

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

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

    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