BEUDAMED
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    ESOPHAGEAL MOTILITY TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DW-1C

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

    BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    KINAIR III

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code INX·April 2, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 26, 2012

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 15, 2010

    Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023