BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    PJ'S SERENITY

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

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053647·ORTHOS LSM 6DG -10T B/T NDX LL 18

    CREATION

    FDA UDI
    Gc Orthodontics America Inc.·D78813222000101·CREATION ROTH 022/UL2 8T 9A

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADEPT 1064/532 LASER

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 31, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    FUJIFILM 600 SERIES ENDOSCOPE EC-600WM

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·January 22, 2025

    HEARTMATE II SYSTEM CONTROLLER, US, EP

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 22, 2020

    INCEPTA

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DYB·June 14, 2011

    PROXIMATE*HCS HEMORR CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 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

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021