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

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    STRYKER ARIA PNEUMATIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AF531

    FDA UDI
    Respironics, Inc.·00606959007437·AF531 Mask with Entrainment Elbow, Leak 2, 4 Po...

    OLYMPUS SUCTION PUMP, MODEL KV-5

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

    HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    EZ-IO POWER DRIVER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FMI·December 14, 2020

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 30, 2011

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·June 13, 2008

    EZ-IO POWER DRIVER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FMI·December 14, 2020

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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