FDA 510(k) Applications Submitted by Anureet Singh
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240330 |
02/05/2024 |
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) |
O&M Halyard, Inc. |
| K232806 |
09/12/2023 |
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) |
Owens & Minor (O&M) Halyard, Inc. |
| K232820 |
09/13/2023 |
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) |
Owens & Minor (O&M) Halyard, Inc. |
| K232894 |
09/18/2023 |
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) |
Owens & Minor (O&M) Halyard, Inc. |
| K233022 |
09/22/2023 |
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Sm |
Owens & Minor (O&M) Halyard, Inc. |
| K234050 |
12/21/2023 |
HALYARD« ONE-STEP« Sterilization Wrap, HALYARD« QUICK CHECK« Sterilization Wrap, HALYARD« SEQUENTIAL Sterilization Wrap and HALYARD« SMART-FOLD« Sterilization Wrap |
O&M Halyard, Inc. |
| K214007 |
12/22/2021 |
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap |
Owens & Minor (O&M) Halyard, Inc. |
|
|
