BEUDAMED
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    SERAQUEST ANTI-THYROGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EXTREMITY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 28, 2025

    POLARCATH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code DQY·March 27, 2013

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·March 18, 2011

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 1, 2008

    VANGUARD INTERLOK FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 4, 2018

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014