BEUDAMED
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    MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820201411·Channels Hedstrom Files 25mm

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040038038·Channels Hedstrom Files 25mm, #70

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101830·Burs FG 557, Pkg/100

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037314319·K-WIRE CENTER GUIDE Ø41 mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450151938·

    IMPLANT: HA, 10 MM, INTEGRAL, 4.0

    FDA Adverse Event
    Injury ·CALCITEK, INC.·Product code DZE·November 13, 1996

    ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·December 8, 2020

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Death ·MPRI·Product code DTB·March 25, 2013

    BONE MARROW BIOPSY NDL,

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FCG·March 16, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·June 22, 2021

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code HAW·December 23, 2020

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR GERMANY·Product code MAF·July 16, 2010

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR GERMANY·Product code MAF·July 16, 2010

    ARCHITECT C16000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·October 14, 2020

    CHAIT PERCUTANEOUS CECOSTOMY CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KNT·June 10, 2025

    Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12. 1006-9321-000-007601 13. 1006-9321-000-009266 14. 1006-9321-000-008526 15. 1006-9321-000-116507 16. 1006-9321-000-009244 17. 1006-9321-000-012769 18. 1006-9320-000-004497 19. 1006-9320-000-009697 20. 1006-9320-000-014484 21. 1006-9321-000-008072 22. 1006-9321-000-007618 23. 1006-9321-000-013784 24. 1006-9320-000-010963 25. 1006-9320-000-014485 26. 1006-9320-000-008839 27. 1006-9321-000-017374 28. 1006-9321-000-014553 29. 1006-9031-000 30. 1006-9321-000-000533 31. 1006-9321-000-007785 32. 1006-9320-000-016418 33. 1006-9320-000-013302 34. 1006-9320-000-020339 35. 1006-9320-000-002141 36. 1006-9320-000-009193 37. 1006-9320-000-014443 38. 1006-9320-000-008124 39. 1006-9321-000-009347 40. 1006-9320-000-009310 41. 1006-9320-000-004623 42. 1006-9321-000-020437 43. 1006-9321-000-025830 44. 1006-9321-000-004690 45. 1006-9321-000-011348 46. 1006-9114-000 47. 1006-9322-000 48. 1006-9321-000-006678 49. 1006-9321-000-043401 50. 1006-9322-000-043399 51. 1006-9320-000-018778 52. 1006-9320-000-010161 53. 1006-9320-000-009400 54. 1006-9320-000-007948 55. 1006-9321-000-001309 56. 1006-9321-000-008305 57. 1006-9321-000-027472 58. 1006-9321-000-008643 59. 1006-9320-000-008841 60. 1006-9320-000-010102 61. 1006-9322-000-020407 62. 1006-9321-000-004831 63. 1006-9320-000-010684 64. 1006-9320-000-014654 65. 1006-9320-000-006392 66. 1006-9320-000-009056 67. 1006-9321-000-025850 68. 1006-9320-000-000473 69. 1006-9320-000-017639 70. 1006-9321-000-003110 71. 1006-9321-000-019653 72. 1006-9321-000-008529 73. 1006-9321-000-010029 74. 1006-9321-000-005790 75. 1006-9320-000-010177 76. 1006-9320-000-028131 77. 1006-9321-000-006318 78. 1006-9322-000-106884 79. 1006-9320-000-004596 80. 1006-9321-000-006645 81. 1006-9321-000-010584 82. 1006-9320-000-007779 83. 1006-9320-000-025679 84. 1006-9320-000-011509 85. 1006-9320-000-008650 86. 1006-9321-000-020045 87. 1006-9321-000-014996 88. 1006-9320-000-015449 89. 1006-9320-000-010685 90. 1006-9321-000-000266 91. 1006-9321-000-019680 92. 1006-9321-000-004778 93. 1006-9321-000-004424 94. 1006-9321-000-008747 95. 1006-9320-000-009249 96. 1006-9320-000-010834 97. 1006-9320-000-022596 98. 1006-9024-000 99. 1006-9026-000 100. 1006-9322-000-011934 101. 1006-9322-000-049412 102. 1006-9322-000-110551 103. 1006-9320-000-019424 104. 1006-9321-000-017187 105. 1006-9321-000-005997 106. 1006-9321-000-091883 107. 1006-9321-000-004524 108. 1006-9321-000-013425 109. 1006-9320-000-015413 110. 1006-9321-000-007378 111. 1006-9320-000-010661 112. 1006-9321-000-005998 113. 1006-9321-000-156642 114. 1006-9320-000-015195 115. 1006-9320-000-017086 116. 1006-9320-000-017852 117. 1006-9321-000-001974 118. 1006-9321-000-010236 119. 1006-9321-000-007641 120. 1006-9321-000-014028 121. 1006-9321-000-015552 122. 1006-9321-000-011524 123. 1006-9321-000-009297 124. 1006-9320-000-017427 125. 1006-9320-000-017498 126. 1006-9321-000-022470 127. 1006-9321-000-024751 128. 1006-9321-000-007642 129. 1006-9321-000-007636 130. 1006-9321-000-029968 131. 1006-9321-000-039161 132. 1006-9321-000-035978 133. 1006-9321-000-011702 134. 1006-9321-000-043612 models truncated

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 25, 2019