Panels › General, Plastic Surgery › Product code MSH · Class 2
Respirator, Surgical
Regulation 878.4040
0510(k)s in 12 months (35 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MSH
| Company | 510(k)s | Recalls |
|---|---|---|
| Inovel, LLC | 5 | 2 |
| Aearo Co. | 4 | 0 |
| Louis M. Gerson Co., Inc. | 3 | 0 |
| 3M Company | 2 | 0 |
| Moldex/Metric, Inc. | 2 | 0 |
| Tecnol Medical Products, Inc. | 2 | 0 |
| 3M Healthcare | 1 | 0 |
| Alpha Protech, Inc. | 1 | 0 |
| Dukal Corporation | 1 | 0 |
| Handan Hengyong Protective & Clean Products Co., L | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2024 | K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small Owens & Minor (O&M) Halyard, Inc. | MSH |
| Apr 4, 2018 | K172963 | Master-Frank N95 Particulate Respirator Master & Frank Enterprise Co., Ltd., CN | MSH |
| Aug 10, 2017 | K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S 3M Healthcare | MSH |
| Jul 15, 2016 | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 San-M Package Co., Ltd., JP | MSH |
| Oct 28, 2015 | K141876 | Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pa Pasture Pharma Pte, Ltd. | MSH |
| Feb 11, 2013 | K121069 | 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 3M Company | MSH |
| Nov 19, 2010 | K102923 | BARRIER N95 PARTICULATE RESPIRATOR Molnlycke Health Care | MSH |
| Oct 6, 2010 | K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES Prestige Ameritech | MSH |
| Sep 13, 2010 | K102173 | MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 Moldex/Metric, Inc. | MSH |
| May 4, 2010 | K100139 | SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 Safelife Corp. | MSH |
| Oct 21, 2009 | K092824 | N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 Alpha Protech, Inc. | MSH |
| Apr 27, 2009 | K090131 | DS N95 SURGICAL MASKS AND FLAT SURGICAL Shanghai Dasheng Health Products, CN | MSH |
| Apr 4, 2008 | K080827 | HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 Handan Hengyong Protective & Clean Products Co., L, CN | MSH |
| Jan 8, 2008 | K072067 | N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 Shuenn Bao Shing Corporation, TW | MSH |
| Nov 8, 2007 | K072359 | AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C Aearo Company | MSH |
| May 30, 2007 | K070692 | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK Dukal Corporation | MSH |
| Apr 18, 2007 | K070168 | N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C Aearo Company | MSH |
| Apr 11, 2007 | K070782 | WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F Survivair Respirators, LLC | MSH |
| Mar 2, 2007 | K070139 | WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 Survivair, Inc. | MSH |
| Feb 23, 2007 | K063023 | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 3M Company | MSH |
| Jan 12, 2007 | K063747 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A Inovel, LLC | MSH |
| Dec 8, 2006 | K063334 | SHANGHAI GANGHAI MODEL GIKO 1400 Shanghai Gangkai Purifying Products Co., Ltd. | MSH |
| Dec 1, 2006 | K063013 | PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S Aearo Company | MSH |
| Nov 17, 2006 | K061375 | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 Louis M. Gerson Co., Inc. | MSH |
| Oct 24, 2006 | K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC | MSH |
| Oct 11, 2006 | K062663 | MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Moldex/Metric, Inc. | MSH |
| Jul 12, 2006 | K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS Inovel, LLC | MSH |
| May 19, 2005 | K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC | MSH |
| Apr 11, 2005 | K050193 | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR Louis M. Gerson Co., Inc. | MSH |
| Nov 10, 2004 | K041855 | PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S Aearo Co. | MSH |
| Sep 30, 2004 | K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP Inovel, LLC | MSH |
| Jul 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 Makrite Industries, Inc. | MSH |
| Dec 22, 1997 | K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL Tecnol Medical Products, Inc. | MSH |
| Apr 30, 1997 | K970448 | PCM 2000; ISOLAIR APR MODEL 2735 Tecnol Medical Products, Inc. | MSH |
| May 9, 1996 | K960778 | ISOLAIR APR TYPE N95 Louis M. Gerson Co., Inc. | MSH |
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