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

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    Thermi Injectable RF Electrodes

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

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989029796·ARCH REV.CURVE NITI LO16 DIA. PK10

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776163785·VAN BUREN URETH SNDS FR

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306820588·Westcott Scissor slightly cvd; sharp tips

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107224·TRIAL 90-SRK-170116 POLY UCCS 1X16MM

    POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LASERTOUCHONE (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    Widex

    FDA UDI
    Widex A/S·05706069923889·WIDEX MOMENT MBB3D 30 (Dark cherry)

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 14, 2014

    UNKNOWN NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 14, 2013

    FOUNDATION SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·June 22, 2011

    SINGLE USE GUIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 25, 2017

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

    RADIFOCUS GLIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·August 7, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    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