BEUDAMED
    32 results · 22ms · Sources: EU EUDAMED, US FDA

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    Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

    FDA 510(k)
    FDA Unclassified ·Unknown

    2008® Series Hemodialysis Machines

    FDA UDI
    Fresenius Usa, Inc.·00840861100859·2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306822766·Poole Aspiration Tube - 30fr, straight, 8 3/4" ...

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101087·HELVESTON "BARBIE" RETRACTOR

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402313·Guide Rod, Tibial Cone, D 10/180 L

    HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS

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

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·May 12, 2020

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 25, 2020

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 21, 2014

    SPACEMAKER BLUNT TIP TROCAR 10MM

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GCJ·June 13, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 27, 2011

    REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·December 11, 2025

    REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·November 11, 2024

    REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022

    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

    FDA Enforcement
    Class II ·Terminated·Biocomposites, Ltd.·December 30, 2020

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

    FDA Enforcement
    Class I ·Terminated·Galemed Corporation·January 1, 2020

    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    FDA Enforcement
    Class I ·Terminated·Galemed Corporation·January 1, 2020

    REVOLUTION PHISIO CENTRIFUGAL PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021

    REVOLUTION PHISIO CENTRIFUGAL PUMP

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021