Chrysalis Intelligence · Sponsors · Owens & Minor (O&M) Halyard, Inc.

Owens & Minor (O&M) Halyard, Inc.

Mechanicsville, VA, US · 11 510(k) clearances

Total clearances
11
2022-07-27 → 2025-05-30
Last 12 months
0
Product codes
4
Most recent
2025-05-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FXX 8 2025-05-30
FYC Gown, Isolation, Surgical Class II General, Plastic Surgery 1 2024-05-16
MSH Respirator, Surgical Class II General, Plastic Surgery 1 2024-01-12
FRG Wrap, Sterilization Class II General Hospital 1 2022-07-27
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2025-05-30 K243010 Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce FXX
2024-07-02 K232824 FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) FXX
2024-07-01 K232777 FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) FXX
2024-06-21 K232807 Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) FXX
2024-06-14 K232812 Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) FXX
2024-06-07 K232806 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) FXX
2024-06-04 K232820 HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) FXX
2024-05-16 K232849 Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) FYC Class II General, Plastic Surgery
2024-01-12 K233022 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 Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small MSH Class II General, Plastic Surgery
2024-01-08 K232894 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) FXX
2022-07-27 K214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap FRG Class II General Hospital