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

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    MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131189523·K220, ITC P R BE

    IgA RID plate Kit

    FDA UDI
    KENT LABORATORIES INC·B1761025·Radial immunodiffusion plate package for human ...

    Zavation

    FDA UDI
    Zavation LLC·00842166196568·Whitney TLIF 25, 6deg 11mm

    Paragon 28

    FDA UDI
    Provision·B504OMP9911025110·

    Reprocessed 2.5mm Cannulated Drill Bit AO, 112mm

    FDA UDI
    SURETEK MEDICAL·B390P9911025111·

    Monster Screw System

    FDA UDI
    Paragon 28, Inc.·00889795040596·Over Drill, 2.5 x 110mm, Cannulated, AO

    ZAVATION

    FDA UDI
    Zavation LLC·00842166179295·Sizer, 0 Deg, 9 & 10 mm w/stop

    Zavation

    FDA UDI
    Zavation LLC·00842166196766·11G BEVELED TROCAR

    FETALTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    WATERLASE MILLENNIUM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

    DELTAFILL10 6MM X 16CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 5, 2021

    K1025-01-EDT

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·6 devices

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 9, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 19, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·May 20, 2011

    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·March 23, 2022

    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FSA·January 14, 2022

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025