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

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    ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068

    FDA 510(k)
    FDA Class 2 ·Radiology

    LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2

    FDA 510(k)
    FDA Class 2 ·Dental

    NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VERSYS FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·February 25, 2016

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·February 28, 2013

    TANDEM T"SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 2, 2014

    FLEXION PACING LEAD

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DTB·February 4, 2011

    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    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