BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123202096·TC METZ-LAHEY SCS 5-3/4 CVD S/

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306805738·Marina Nylon/Steel Mallet, 265 grams, 1" OD, 18cm

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025

    ULTRASONIC TIPS WITH DIAMOND COATING

    FDA 510(k)
    FDA Class 2 ·Dental

    SURGITRON IEC II

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

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 25, 2003

    ENDORETURN ARTERIAL CANNULA

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DWF·October 27, 2014

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·August 11, 2011

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 2, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 23, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    APPLIED MEDICAL·Product code FZP·October 15, 2012

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·February 8, 2013

    Colonoscope, Model Number PCF-H180AL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 12, 2023

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 22, 2012

    Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·May 14, 2008