BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-9000-000-004993 12. 1009-9011-000-004795 13. 1009-9000-000-013407 14. 1009-9000-000-004604 15. 1009-9000-000-017674 16. 1009-9000-000-008763 17. 1009-9000-000-008306 18. 1009-9000-000-003277 19. 1009-9000-000-004166 20. 1009-9000-000-008560 21. 1009-9000-000-000299 22. 1009-9000-000-011444 23. 1009-9000-000-003529 24. 1009-9000-000-005666 25. 1009-9000-000-019821 26. 1009-9011-000 27. 1009-9000-000-017345 28. 1009-9000-000-009893 29. 1009-9000-000-007258 30. 1009-9000-000-004959 31. 1009-9000-000-010185 32. 1009-9000-000-016672 33. 1009-9011-000-017769 34. 1009-9000-000-014329 35. 1009-9011-000-020685 36. 1009-9000-000-026022 37. 1009-9011-000-002912 38. 1009-9000-000-014723 39. 1009-9000-000-013385 40. 1009-9000-000-006725 41. 1009-9000-000-005163 42. 1009-9000-000-004022 43. 1009-9000-000-017939 44. 1009-9000-000-000300 45. 1009-9000-000-018855 46. 1009-9000-000-016724 47. 1009-9000-000-010268 48. 1009-9000-000-011595 49. 1009-9000-000-019277 50. 1009-9011-000-023222 51. 1009-9011-000-015929 52. 1009-9000-000-017824 53. 1009-9000-000-008270 54. 1009-9000-000-010416 55. 1009-9000-000-019089 56. 1009-9000-000-013395 57. 1009-9011-000-021989 58. 1009-9000-000-000517 59. 1009-9000-000-002407 60. 1009-9000-000-008415 61. 1009-9000-000-009597 62. 1009-9000-000-010178 63. 1009-9011-000-010400 64. 1009-9011-000-011366 65. 1009-9000-000-012360 66. 1009-9101-000 67. 1009-9000-000-013787 68. 1009-9000-000-006266 69. 1009-9000-000-014915 70. 1009-9000-000-000290 71. 1009-9000-000-013507 72. 1009-9000-000-011600 73. 1009-9000-000-010595 74. 1009-9000-000-009543 75. 1009-9000-000-011111 76. 1009-9000-000-013378 77. 1009-9000-000-000526 78. 1009-9000-000-010536 79. 1009-9000-000-010116 80. 1009-9000-000-005939 81. 1009-9000-000-008216 82. 1009-9000-000-006786 83. 1009-9000-000-012155 84. 1009-9000-000-012379 85. 1009-9000-000-014000 86. 1009-9011-000-022466 87. 1009-9000-000-009912 88. 1009-9000-000-006906 89. 1009-9000-000-004380 90. 1009-9000-000-010245 91. 1009-9000-000-010413 92. 1009-9000-000-013616 93. 1009-9000-000-009428 94. 1009-9000-000-010597 95. 1009-9000-000-020606 96. 1009-9000-000-010059 97. 1009-9000-000-014122 98. 1009-9000-000-016795 99. 1009-9000-000-012149 100. 1009-9000-000-005760 101. 1009-9000-000-009836 102. 1009-9000-000-016818 103. 1009-9000-000-017699 104. 1009-9000-000-004020 105. 1009-9000-000-013953 106. 1009-9000-000-009583 107. 1009-9000-000-007938 108. 1009-9000-000-007336 109. 1009-9000-000-010435 110. 1009-9011-000-016719 111. 1009-9000-000-024098 112. 1009-9011-000-004634 113. 1009-9011-000-016794 114. 1009-9011-000-005431 115. 1009-9000-000-000598 116. 1009-9011-000-005442 117. 1009-9000-000-022792 118. 1009-9000-000-003950 119. 1009-9000-000-013921 120. 1009-9000-000-011116 121. 1009-9000-000-017203 122. 1009-9000-000-003335 123. 1009-9000-000-008264 124. 1009-9000-000-009868 125. 1009-9011-000-015245 truncated text

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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018