BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    XCT 2000 L PQCT BONE DENSITOMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICRODOT XTRA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)

    FDA 510(k)
    FDA Class 2 ·Immunology

    DAILIES TOTAL 1

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code LPL·August 3, 2012

    DAILIES TOTAL 1

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code MVN·July 19, 2012

    DORADO PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·February 1, 2013

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWQ·August 6, 2014

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011

    DAILIES TOTAL 1

    FDA Adverse Event
    Injury ·CIBA VISION GMBH·Product code MVN·November 9, 2012

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026