24 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586015861·
TAMARIN BLUE PTCA RX DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARFIL DC CEMENT
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·October 22, 2008
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·June 28, 2013
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·August 16, 2011
BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN.
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·September 23, 2019
BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN.
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·November 21, 2019
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·September 12, 2019
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
EVIS EXERA DUODENOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·May 3, 2021
EVIS EXERA II DUODENOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·May 3, 2021
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 7, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 5, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 5, 2023
BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN.
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·September 6, 2019
BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 24 G X 0.75 IN.
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 14, 2019
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. NDL, GRIPPER, 19G X 1.25" (32MM), 12/BX; 6. NDL, GRIPPER, 22G X .75" (19MM), 12/BX; 7. NDL, GRIPPER, 19G X .75" (19MM), 12/BX; 8. NDL, GRIPPER, 20G X .625" (16MM), 12/BX; 9. NDL, GRIPPER, 22G X .625" (16MM), 12/BX; 10. NDL, GRIPPER PLUS, 22G X 1" (25MM), 12/BX; 11. NDL, GRIPPER PLUS, 22G X 1.25" (32MM), 12/BX; 12. NDL, GRIPPER PLUS, 20G X 1" (25MM) 12/BX; 13. NDL, GRIPPER PLUS, 20G X 1.25" (32MM) 12/BX; 14. NDL, GRIPPER PLUS, 19G X 1" (25MM) 12/BX; 15. NDL, GRIPPER PLUS, 19G X 1.25" (32MM) 12/BX; 16. NDL, GRIPPER PLUS, 22G X .75" (19MM) 12/BX; 17. NDL, GRIPPER PLUS, 20G X .75" (19MM) 12/BX; 18. NDL, GRIPPER PLUS, 19G X .75" (19MM) 12/BX; 19. NDL, GRIPPER PLUS, 20G X .625" (16MM) 12/BX; 20. NDL, GRIPPER PLUS, 22G X .625" (16MM) 12/BX; 21. NDL, GRIPPER PLUS, 22G X .625" (16MM), Y-SITE 12/BX; 22. NDL, GRIPPER PLUS, 22G X .75" (19MM), Y-SITE 12/BX; 23. NDL, GRIPPER PLUS, 22G X 1" (25MM), Y-SITE 12/BX; 24. NDL, GRIPPER PLUS, 22G X 1.25" (32MM), Y-SITE 12/BX; 25. NDL, GRIPPER PLUS, 20G X .625" (16MM), Y-SITE 12/BX; 26. NDL, GRIPPER PLUS, 20G X .75" (19MM), Y-SITE 12/BX; 27. NDL, GRIPPER PLUS, 20G X 1" (25MM), Y-SITE 12/BX; 28. NDL, GRIPPER PLUS, 20G X 1.25" (32MM), Y-SITE 12/BX; 29. NDL, GRIPPER PLUS, 19G X .75" (19MM), Y-SITE 12/BX; 30. NDL, GRIPPER PLUS, 19G X 1" (25MM), Y-SITE 12/BX; 31. NDL, GRIPPER PLUS, 19G X 1.25" (32MM), Y-SITE 12/BX; 32. NDL, GRIPPER, 22G X .625" (16MM), Y-SITE 12/BX; 33. NDL, GRIPPER, 22G X .75" (19MM), Y-SITE 12/BX; 34. NDL, GRIPPER, 22G X 1" (25MM), Y-SITE 12/BX; 35. NDL, GRIPPER, 22G X 1.25" (32MM), Y-SITE 12/BX; 36. NDL, GRIPPER, 20G X .625" (16MM), Y-SITE 12/BX; 37. NDL, GRIPPER, 20G X .75" (19MM), Y-SITE 12/BX; 38. NDL, GRIPPER, 20G X 1" (25MM), Y-SITE 12/BX; 39. NDL, GRIPPER, 20G X 1.25" (32MM), Y-SITE 12/BX; 40. NDL, GRIPPER, 19G X .75" (19MM), Y-SITE 12/BX; 41. NDL, GRIPPER, 19G X 1.25" (32MM), Y-SITE 12/BX; 42. NDL, GRIPPER PLUS, 22G X .625" (16MM), NEEDLELESS Y-SITE 12/BX; 43. NDL, GRIPPER PLUS, 22G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 44. NDL, GRIPPER PLUS, 22G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 45. NDL, GRIPPER PLUS, 20G X .625" (16MM), NEEDLESS Y-SITE 12/BX; 46. NDL, GRIPPER PLUS, 20G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 47. NDL, GRIPPER PLUS, 20G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 48. NDL, GRIPPER PLUS, 20G X 1.25" (32MM), NEEDLELESS Y-SITE 12/BX; 49. NDL, GRIPPER PLUS, 19G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 50. NDL, GRIPPER PLUS, 19G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 51. NDL, GRIPPER PLUS, 19G X 1.25" (32MM), NEEDLELESS Y-SITE 12/BX; 52. NDL, GRIPPER MICRO, 22G X .75 12/BOX; 53. NDL, GRIPPER MICRO, 22G X 1" 12/BOX; 54. NDL, GRIPPER MICRO, 22G X 1.25" 12/BOX; 55. NDL, GRIPPER MICRO, 20G X .75" 12/BOX; 56. NDL, GRIPPER MICRO, 20G X 1" 12/BOX; 57. NDL, GRIPPER MICRO, 20G X 1.25" 12/BOX; 58. NDL, GRIPPER MICRO, 19G X .75" 12/BOX; 59. NDL, GRIPPER MICRO, 19G X 1" 12/BOX; 60. NDL, GRIPPER MICRO, 19G X 1.25" 12/BOX; 61. NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 62. NDL, GRIPPER MICRO, 22G X 1", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 63. NDL, GRIPPER MICRO, 22G X 1.25", NAC Y-SITE 12/BOX; 64. NDL, GRIPPER MICRO, 20G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 65. ND
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 30, 2019