BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 27, 2010

    DIMENSION® XPAND WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD·Product code JJE·December 21, 2012

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC·Product code GJS·May 19, 2014

    Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·July 8, 2015

    Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024