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

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    Aorta-CAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    iTero Lumina RMA Scanning Unit

    FDA UDI
    Align Technology, Inc.·00816063021469·Scanning unit (wand) replacement package

    GEMINI

    FDA Adverse Event
    Other ·MEDLINE·Product code FRG·November 10, 2014

    NEUROSPECTQUAD GAMMA CAMERA

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEMINI STERILZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·August 12, 2011

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 9, 2013

    CustMbite, Model Number CBT-SRS-UL

    FDA Enforcement
    Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017