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

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    NextAR™ TKA Platform My Knee PPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    HANDHELD GAMMA FINDER (HGF)

    FDA 510(k)
    FDA Class 1 ·Radiology

    RANDOX COCAINE METABOLITE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 22, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·HISTORICAL CPI ST. PAUL·Product code DTB·July 9, 2013

    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·July 17, 2024

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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