BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UREA NITROGEN REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROGESTERONE SYSTEM BY EIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HENRY SCHEIN ONE STEP+ HCG URINE CASSETTE TEST

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

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MFG. CO.·Product code KOO·October 14, 2010

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 21, 2012

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic 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