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

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    MODEL 495-01 PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TRACH MATE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MC 2002 OSTOMY POUCHES & SKIN FLANGES

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code JDQ·June 12, 2017

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 2, 2014

    SPIDER FLEXIBLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·TRANSENTERIX INC.·Product code OTJ·November 8, 2012

    CE INFUSOR,LV 10 ML/H 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 24, 2010

    CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FPA·March 17, 2017

    PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 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

    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·January 16, 2017

    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 20, 2023

    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 20, 2023