BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    SMILERS

    FDA 510(k)
    FDA Class 2 ·Dental

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586027697·

    CLO-SURPLUS P.A.D.

    FDA 510(k)
    FDA Unclassified ·Unknown

    SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

    CRYSTALENS INTRAOCULAR LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·October 24, 2014

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 12, 2011

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 11, 2023

    DELTEC GRIPPER PLUS

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·September 25, 2024

    DELTEC LUERACTIVE Y-SITE GRIPPER PLUS

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·April 23, 2025

    RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 12, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 15, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 5, 2023

    GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. NDL, GRIPPER, 19G X 1.25" (32MM), 12/BX; 6. NDL, GRIPPER, 22G X .75" (19MM), 12/BX; 7. NDL, GRIPPER, 19G X .75" (19MM), 12/BX; 8. NDL, GRIPPER, 20G X .625" (16MM), 12/BX; 9. NDL, GRIPPER, 22G X .625" (16MM), 12/BX; 10. NDL, GRIPPER PLUS, 22G X 1" (25MM), 12/BX; 11. NDL, GRIPPER PLUS, 22G X 1.25" (32MM), 12/BX; 12. NDL, GRIPPER PLUS, 20G X 1" (25MM) 12/BX; 13. NDL, GRIPPER PLUS, 20G X 1.25" (32MM) 12/BX; 14. NDL, GRIPPER PLUS, 19G X 1" (25MM) 12/BX; 15. NDL, GRIPPER PLUS, 19G X 1.25" (32MM) 12/BX; 16. NDL, GRIPPER PLUS, 22G X .75" (19MM) 12/BX; 17. NDL, GRIPPER PLUS, 20G X .75" (19MM) 12/BX; 18. NDL, GRIPPER PLUS, 19G X .75" (19MM) 12/BX; 19. NDL, GRIPPER PLUS, 20G X .625" (16MM) 12/BX; 20. NDL, GRIPPER PLUS, 22G X .625" (16MM) 12/BX; 21. NDL, GRIPPER PLUS, 22G X .625" (16MM), Y-SITE 12/BX; 22. NDL, GRIPPER PLUS, 22G X .75" (19MM), Y-SITE 12/BX; 23. NDL, GRIPPER PLUS, 22G X 1" (25MM), Y-SITE 12/BX; 24. NDL, GRIPPER PLUS, 22G X 1.25" (32MM), Y-SITE 12/BX; 25. NDL, GRIPPER PLUS, 20G X .625" (16MM), Y-SITE 12/BX; 26. NDL, GRIPPER PLUS, 20G X .75" (19MM), Y-SITE 12/BX; 27. NDL, GRIPPER PLUS, 20G X 1" (25MM), Y-SITE 12/BX; 28. NDL, GRIPPER PLUS, 20G X 1.25" (32MM), Y-SITE 12/BX; 29. NDL, GRIPPER PLUS, 19G X .75" (19MM), Y-SITE 12/BX; 30. NDL, GRIPPER PLUS, 19G X 1" (25MM), Y-SITE 12/BX; 31. NDL, GRIPPER PLUS, 19G X 1.25" (32MM), Y-SITE 12/BX; 32. NDL, GRIPPER, 22G X .625" (16MM), Y-SITE 12/BX; 33. NDL, GRIPPER, 22G X .75" (19MM), Y-SITE 12/BX; 34. NDL, GRIPPER, 22G X 1" (25MM), Y-SITE 12/BX; 35. NDL, GRIPPER, 22G X 1.25" (32MM), Y-SITE 12/BX; 36. NDL, GRIPPER, 20G X .625" (16MM), Y-SITE 12/BX; 37. NDL, GRIPPER, 20G X .75" (19MM), Y-SITE 12/BX; 38. NDL, GRIPPER, 20G X 1" (25MM), Y-SITE 12/BX; 39. NDL, GRIPPER, 20G X 1.25" (32MM), Y-SITE 12/BX; 40. NDL, GRIPPER, 19G X .75" (19MM), Y-SITE 12/BX; 41. NDL, GRIPPER, 19G X 1.25" (32MM), Y-SITE 12/BX; 42. NDL, GRIPPER PLUS, 22G X .625" (16MM), NEEDLELESS Y-SITE 12/BX; 43. NDL, GRIPPER PLUS, 22G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 44. NDL, GRIPPER PLUS, 22G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 45. NDL, GRIPPER PLUS, 20G X .625" (16MM), NEEDLESS Y-SITE 12/BX; 46. NDL, GRIPPER PLUS, 20G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 47. NDL, GRIPPER PLUS, 20G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 48. NDL, GRIPPER PLUS, 20G X 1.25" (32MM), NEEDLELESS Y-SITE 12/BX; 49. NDL, GRIPPER PLUS, 19G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 50. NDL, GRIPPER PLUS, 19G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 51. NDL, GRIPPER PLUS, 19G X 1.25" (32MM), NEEDLELESS Y-SITE 12/BX; 52. NDL, GRIPPER MICRO, 22G X .75 12/BOX; 53. NDL, GRIPPER MICRO, 22G X 1" 12/BOX; 54. NDL, GRIPPER MICRO, 22G X 1.25" 12/BOX; 55. NDL, GRIPPER MICRO, 20G X .75" 12/BOX; 56. NDL, GRIPPER MICRO, 20G X 1" 12/BOX; 57. NDL, GRIPPER MICRO, 20G X 1.25" 12/BOX; 58. NDL, GRIPPER MICRO, 19G X .75" 12/BOX; 59. NDL, GRIPPER MICRO, 19G X 1" 12/BOX; 60. NDL, GRIPPER MICRO, 19G X 1.25" 12/BOX; 61. NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 62. NDL, GRIPPER MICRO, 22G X 1", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 63. NDL, GRIPPER MICRO, 22G X 1.25", NAC Y-SITE 12/BOX; 64. NDL, GRIPPER MICRO, 20G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 65. ND

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 30, 2019