BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    24PW - Hanta Virus

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White

    24M - Tampa Electric Co.

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)

    ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020

    HAMILTON-C3

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 6, 2013

    GRANFULO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 6, 2013

    I-STAT PT/INRCARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code GJS·November 18, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·August 11, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·February 8, 2014

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 25, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·January 10, 2013

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 30, 2013

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·May 15, 2015

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026