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

FDA 510(k) & PMA Approved Изделия — 12 products

Всего изделий12
Категории0
Последнее решение FDA
ТипНомерНазвание изделияКодДатаДействия
510(k) 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 ProceFXX2025-05-30 Открыть
510(k) 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)FXX2024-07-02 Открыть
510(k) 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)FXX2024-07-01 Открыть
510(k) K232807 Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)FXX2024-06-21 Открыть
510(k) 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)FXX2024-06-14 Открыть
510(k) K232806 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)FXX2024-06-07 Открыть
510(k) K232820 HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)FXX2024-06-04 Открыть
510(k) K232849 Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)FYC2024-05-16 Открыть
510(k) 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 SmallMSH2024-01-12 Открыть
510(k) 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)FXX2024-01-08 Открыть
510(k) K214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapFRG2022-07-27 Открыть
510(k) K192147 Halyard ONE-STEP* Sterilization WrapFRG2019-10-10 Открыть
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