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

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    PACESETTER MODEL 350

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIALYZER, CD-800 COIL

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

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·January 13, 2014

    SINGLE EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 10, 2012

    N/A

    FDA Adverse Event
    Malfunction ·ASCENT HALTHCARE SOLUTIONS·Product code NLQ·August 10, 2010

    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022