BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    CHEMO-TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435062407·MCD Screw 3.0 x 12 mm M2 non lo...

    Skipjack

    FDA UDI
    Seaspine Orthopedics Corporation·10889981139902·11mm x 26mm x 12-15mm, 0 Deg

    GENESIS II TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Edwards Algorithm for Measurement of Blood Hemoglobin

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSTEM 7 DUAL TRIGGER ROTARY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·May 23, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 13, 2012

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, 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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018