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

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    360CAS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR

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

    COMP RVRS SHDR GLEN BSPLT +HA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 3, 2020

    SMOOTH OVL MLV 325CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 12, 2021

    SMOOTH OVL MLV 325CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 12, 2021

    ASR UNI FEMORAL IMPL SIZE 46

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 25, 2014

    HIRES 90K ADVANTAGE IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·July 3, 2013

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·February 17, 2021

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·February 17, 2021

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·February 3, 2020

    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