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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2023 | O&M HALYARD, INC. FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 Open, Classified |
MSH | K974068 |
| Jul 13, 2009 | Inovel LLC Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010. Terminated |
MSH | K042267 |
| Mar 3, 2006 | Inovel LLC Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161. Terminated |
MSH | K051182 |
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