BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

    FDA 510(k)
    FDA Class 2 ·Immunology

    TEMPO AQUA ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STENT SUPPORT GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 15, 2023

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 8, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 18, 2011

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·May 9, 2008

    PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013