BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    INFLUENZA A & B S-ANTIGEN & CONTROLS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780516514·CODMAN® Bayonet Bipolar Forceps Irrigating Non ...

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704080770·CODMAN Bayonet Bipolar Forceps Irrigating Non S...

    CODMAN MALIS

    FDA UDI
    Cerenovus, Inc.·10886704038900·CODMAN MALIS Bayonet Bipolar Forceps Irrigating...

    neria™

    FDA UDI
    Unomedical A/S·05705244003934·Single use infusion set for subcutaneous infusi...

    neria™

    FDA UDI
    Unomedical A/S·05705244000711·Single use infusion set for subcutaneous infusi...

    thalaset™

    FDA UDI
    Unomedical A/S·05705244001411·Single use infusion set for subcutaneous infusi...

    METRX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G-CINCH SUTURE GRASPER

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

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

    SUNBEAM

    FDA Adverse Event
    Death ·SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS·Product code IRT·May 1, 2014

    THERASPHERE

    FDA Adverse Event
    Death ·NORDION (CANADA) INC.·Product code NAW·October 19, 2012

    IRIDEX OCCULIGHT SLX, AND OTHER IRIDEX LASER

    FDA Adverse Event
    Malfunction ·IRIDEX CORPORATION·Product code GEX·August 11, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

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

    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

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