BEUDAMED
    20 results · 27ms · Sources: EU EUDAMED, US FDA

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    10PW - Penn Power & Light

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012179·10PW - Penn Power & Light

    HemoCue Hb 301 System

    FDA 510(k)
    FDA Class 2 ·Hematology

    OptoMonitor 3

    FDA UDI
    Opsens Inc·07540184012176·

    NeoFuse Ti3D PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345021570·Ti3D CAGE 20L x 12W x 17H

    NeoFuse HA Enhanced PLIF/TLIF

    FDA UDI
    XENIX MEDICAL LLC·00818345020498·HA CAGE 20L x 12W x 17H

    Ophthlamic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668115541·INFANT SPECULUM 4MM SOLID (10/BX)

    INSIDE VIEW

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

    AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 12, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 12, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 21, 2022

    BD PHASEAL¿ INFUSION ADAPTER C100

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 20, 2023

    CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 20, 2008

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011

    12/14 ARTICUL 40MM M SPEC+5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 2, 2013

    BD CATHENA¿ SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022

    Surpria 64: Software Version V3.11, V3.22

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024