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

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    IMMULITE CORTISOL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    URINARY CATHETERS

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

    CAS PSI KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPELLA CP

    FDA Adverse Event
    Death ·ABIOMED, INC.·Product code OZD·November 18, 2025

    HYDROVIEW INTRAOCULAR LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·June 26, 2014

    PINNACLE MTL INS NEUT 52 OD X 36 ID

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 15, 2010

    S3 EX - 3005

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 28, 2013

    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