BEUDAMED
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    IMPACT BALLOON DILATION CATHETER

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

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009

    IMMULITE 2000 FREE T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bonebridge

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    WALLSTENT-UNI¿ ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code JCT·February 28, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·July 7, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·February 10, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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