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

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    I.V. EXTENSION SET OR I.V. ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983073·posteriors; shade C1; size XL; lower jaw

    SMG Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THEKEN ATOLL CERVICO-THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 4, 2011

    ILS 29MM CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 6, 2014

    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 REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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