BEUDAMED
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    PASS LP™ Spinal System, CD Horizon™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586029981·

    MRI SYTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSALAB APM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 31, 2025

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·February 14, 2023

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 27, 2008

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2011

    ALIGN URETHRAL SUPPORT SUPPORT

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 2, 2013

    ALIYA

    FDA Adverse Event
    Injury ·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026

    Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    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