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

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    Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    PSORIA-LIGHT

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

    INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE

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

    LCS COMP RP INSERT LG 10MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code NJL·December 23, 2010

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    VISTA BASIC SAFETY INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·June 20, 2011

    COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·March 27, 2017

    COMPREHENSIVE REVERSE CENTRAL SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·March 27, 2017

    Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024