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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Coseal Surgical Sealant

    FDA UDI
    BAXTER HEALTHCARE CORPORATION·05413765404627·Coseal Surgical Sealant (Coseal) is composed of...

    Nu-Edge Cobalt Chromium Brackets

    FDA UDI
    TP ORTHODONTICS INC·00192029046111·UR CEN

    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code NBE·December 6, 2023

    LYMPHANGIOGRAPHY SET SPECIAL 30G

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MULTIPLE BURN DRESSING

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

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·December 21, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 30, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 3, 2014

    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp·June 8, 2016

    Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

    FDA Recall
    Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

    FDA Recall
    Terminated ·Baxter Healthcare Corp·Product code NBE·May 12, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55

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