BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    KULTSURE STARSWAB(M240), MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Microbiology

    eCligner

    FDA 510(k)
    FDA Class 2 ·Dental

    POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 9, 2013

    FREESTYLE HANDS-FREE BREAST PUMP

    FDA Adverse Event
    Other ·MEDELA, INC.·Product code HGX·October 25, 2010

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 18, 2014

    PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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

    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011