BEUDAMED
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    VOCOM IMPLANT- 8MM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Per-Q-Cath

    FDA UDI
    Bard Access Systems, Inc.·00801741107429·Catheter Placement Kit

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0005331·CC/ Dentine D-A3

    OmniCycle Elite

    FDA UDI
    medica - Medizintechnik GmbH·04041925002799·Powered exercise therapy bicycle

    MENICON Z

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MENICON SF-P

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964106675·Endo Carry-On Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964106217·Endo Carry-On Procedure Kit

    NA

    FDA UDI
    Zimmer, Inc.·00889024023321·

    Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.

    FDA Enforcement
    Class II ·Terminated·Accelerated Care Plus Corporation·August 7, 2013

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.,·Product code LHI·May 4, 2026

    SYSTEM, PERITONEAL AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 12, 2013

    PROWLER SELECT MICROCATHETERS

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code KRA·February 24, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·February 15, 2008

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    LEEP PRECISION GENERATOR 120VAC

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·March 11, 2024

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    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 Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·July 19, 2019

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012