23 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHIRAVAC Blood Collection Needles
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OsteoMed
FDA UDI
OSTEOMED LLC·00845694019200·1.2mm/1.6mm Countersink, Manual
Zavation
FDA UDI
Zavation LLC·00842166132054·Ti3Z CIF 12mmx14mmx9mm -10 deg
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193113302·HA PEEK EVOS Straight, ,9mmx8mmx 26mm , FLAT 0...
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869654173·MOSS VRS rod rotation key, angled 45°
RANDOX C-REACTIVE PROTEIN
FDA 510(k)
FDA Class 2
·Immunology
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TFNA HELICAL BLADE L80 TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·December 20, 2017
BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·April 18, 2022
BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. Item # 40201: Item Lot # Cornea Coat Lot # Expiration Date M423801008 M419300908 2010-07 M427731108 M419300908 2010-07 M428631008 M419300908 2010-07 M434211208 M422951008 2010-08 M439670109 M422951008 2010-08 M443700109 M435381208 2010-09 M44887 M442120109 2010-10 Item # 40202: Item Lot # Cornea Coat Lot # Expiration Date M427641008 M419300908 2010-07 M45414 M435381208 2010-09 Item # 40203: M416600908 M415950808 2010-06 M422941008 M416620908 2010-07 M427651108 M422951008 2010-08 M442710109 M435381208 2010-09 M44870 M442120109 2010-10 Item # 40204: Item Lot # Cornea Coat Lot # Expiration Date M421580908 M416620908 2010-07 M435201208 M422951008 2010-08 M45645 M435381208 2010-09 Item # 40205: Item Lot # Cornea Coat Lot # Expiration Date M410510708 M409570708 2010-05 M412790708 M409570708 2010-05 M419280908 M415950808 2010-06 M420850908 M415950808 2010-06 M421100908 M416620908 2010-07 M421120908 M416620908 2010-07 M424361008 M419300908 2010-07 M425821008 M421680908 2010-07 M426731008 M421680908 2010-07 M428601008 M419300908 2010-07 M429531108 M421680908 2010-07 M430851108 M421680908 2010-07 M431051108 M422951008 2010-08 M433111108 M422951008 2010-08 M435531208 M430041108 2010-09 M440700109 M430041108 2010-09 M441790109 M435381208 2010-09 M442560109 M430041108 2010-09 M443450109 M422951008 2010-08 M443930109 M442120109 2010-10 M44605 M442120109 2010-10 M44896 M44499 2010-11 M45099 M44499 2010-11 M45243 M435381208 2010-09 M45248 M44897 2010-12 M45866 M44897 2010-12 M45870 M435381208 2010-09 Item # 10206: Item Lot # Cornea Coat Lot # Expiration Date M418460908 M416620908 2010-07 M434741208 M422951008 2010-08 M45646 M435381208 2010-09
FDA Recall
Terminated
·Insight Instruments, Inc.·Product code KYG·May 12, 2010
QUICK SE PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 27, 2009
BD SPINAL NEEDLE 27GA 3.50 IN
FDA Adverse Event
Injury
·BECTON DICKINSON, S.A.·Product code FMI·August 17, 2022
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
FDA Enforcement
Class II
·Terminated·Nipro Diagnostics, Inc.·April 24, 2013
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·October 20, 2008
BARDEX
FDA Adverse Event
Malfunction
·CR BARD·Product code KOD·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
TFNA HELICAL BLADE 80MM STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·January 20, 2021
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 Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·July 19, 2019
TFNA HELICAL BLADE L80 TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·January 17, 2018
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·January 20, 2021