BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

    FDA 510(k)
    FDA Unclassified ·Unknown

    STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS

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

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 27, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 25, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 3, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 26, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 29, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·ANGEL KISS LLC·Product code FTC·February 2, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 4, 2021

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2011

    INTEGRIS BH3000

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code IZI·August 22, 2008

    AMISTEM H, HA COATED STEM SIZE 6 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 30, 2016

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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