BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ZIP™ MIS Interspinous Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

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

    LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 20, 2016

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    PINNACLE SECTOR II CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 11, 2013

    CLICKFINE AP 31GX5MM ASCENDIS 4'500ER

    FDA Adverse Event
    Injury ·YPSOMED AG·Product code FMI·January 19, 2024

    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