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

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    MITEK CUFFTACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964021167·The ENDO CARRY-ON Procedure Kit contains all of...

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496003076·NAOMI 30, SIZE S, VISONE, GRADUATED COMPRESSION...

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113745·CCC CYSTOTOME FORMED 27GA

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    CELL-CHEX

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·March 13, 2013

    CUSTOM EXTRACTOR AND PIN PULLER

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·February 8, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 1, 2020

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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