Home › Device types › MSH
Respirator, Surgical
FDA product code MSH · Class 2 · General, Plastic Surgery
230
Registered devices
195
Adverse events
3
Recalls
35
510(k) clearances
Devices with this code
Crosstex™ Isolator™ Duckbill N95 Surgical Respirator — CROSSTEX INTERNATIONAL, INC.Moldex — MOLDEX-METRIC, INC.Perfetta Ultra Face Mask — PHU BAO GROUP COMPANY LIMITEDPrecept® — PRECEPT MEDICAL PRODUCTS, INC.Defend — YOUNG MYDENT, LLCProGear — PRESTIGE AMERITECH, LTD.Medicom SafeMask — AMD Medicom IncMakrite Industries Inc. — DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.Moldex Airwave Surgical N95 Respirator — MOLDEX-METRIC, INC.Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLCDefend — YOUNG MYDENT, LLCDefend — YOUNG MYDENT, LLCA&Z Pharmaceutical — A & Z Pharmaceutical Inc.LEADER — Cardinal Health 110, Inc.RiskWise Supplies — RiskWise Supplies LLCGPS — GROUP PRACTICE SOLUTIONS INC.3M™ Aura™ — 3M CompanyRiskWise Supplies — RiskWise Supplies LLCKIMBERLY-CLARK® Fluidshield™ Fog-Free Procedure Mask with Splashguard™ Visor — KIMBERLY-CLARK GLOBAL SALES, LLCDefend — YOUNG MYDENT, LLCBarrier — Mölnlycke Health Care ABDefend — YOUNG MYDENT, LLCDefend — YOUNG MYDENT, LLCDefend — YOUNG MYDENT, 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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