Home › Device types › MSH
Respirator, Surgical
FDA product code MSH · Class 2 · General, Plastic Surgery
228
Registered devices
194
Adverse events
3
Recalls
35
510(k) clearances
Devices with this code
Makrite Industries Inc. — Makrite Hubei Industrial Co., Ltd.Medline — MEDLINE INDUSTRIES, INC.Defend — YOUNG MYDENT, LLCDukal — Dukal LLCEssentials By 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC3M™ Vflex™ — 3M CompanyPerfetta Face Mask — PHU BAO GROUP COMPANY LIMITEDDefend — YOUNG MYDENT, LLCCritical Cover — Alpha Pro Tech, Inc.Defend — YOUNG MYDENT, LLCRospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLCDefend — YOUNG MYDENT, LLCCrosstex International — CROSSTEX INTERNATIONAL, INC.Defend — YOUNG MYDENT, LLCZooby Face Masks — YOUNG DENTAL MANUFACTURING I, LLCMarketlab Inc — MARKETLAB INC.Makrite Industries Inc. — Makrite Hubei Industrial Co., Ltd.FLENTS — APOTHECARY PRODUCTS, LLCCareMates — Shepard Medical Products, Inc.Care One — APOTHECARY PRODUCTS, LLCGPS — GROUP PRACTICE SOLUTIONS INC.Makrite Industries Inc. — Makrite Hubei Industrial Co., Ltd.Defend — YOUNG MYDENT, LLCDukal — Dukal LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-09 | O&M HALYARD, INC. | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. |
| 2008-07-23 | Inovel LLC | Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators. |
| 2006-02-20 | Inovel LLC | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labele |
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