BEUDAMED
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    RUBEOLA IGM ELISA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122956·K-WIRE - SINGLE TROCAR 0.8mm DIA x 75mm

    EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD CONNECTA¿ STOPCOCKS

    FDA Adverse Event
    Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·June 30, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 9, 2013

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·November 12, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017