BEUDAMED
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    Surgical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586025679·

    NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FG 6301 DUAL CHNL VOL INF PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    RESIDENT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 12, 2011

    SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·July 9, 2013

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·October 20, 2016

    CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·October 20, 2016

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021