6 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Enforcement
Class II
·Terminated·Unimed Surgical Products, Inc.·September 5, 2012
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Enforcement
Class II
·Terminated·Unimed Surgical Products, Inc.·September 5, 2012
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Enforcement
Class II
·Terminated·Unimed Surgical Products, Inc.·September 5, 2012
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018