Panels › General, Plastic Surgery › Product code OXZ · Class 2
Pediatric/Child Facemask
Regulation 878.4040
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OXZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Kimberly-Clark | 2 | 0 |
| Amd Medicom, Inc. | 1 | 0 |
| Dukal Corporation | 1 | 0 |
| Pac-Dent, Inc. | 1 | 0 |
| Prestige Ameritech | 1 | 0 |
| Primed Medical Products, Inc. | 1 | 0 |
| Shandong Shengquan New Material Co., Ltd. | 1 | 0 |
| Xinxiang Kangbeier Medical Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2023 | K221753 | Kangbeier Child Surgical Mask Xinxiang Kangbeier Medical Technology Co., Ltd., CN | OXZ |
| Nov 22, 2022 | K213427 | PRIMED Pediatric Facemask Primed Medical Products, Inc., CA | OXZ |
| Mar 29, 2022 | K210321 | Dukal Corporation Level 1 Pediatric Face Mask Dukal Corporation | OXZ |
| Oct 10, 2021 | K201514 | Child Face Mask Shandong Shengquan New Material Co., Ltd., CN | OXZ |
| Aug 26, 2021 | K202831 | The iMask Child's Face Mask Pac-Dent, Inc. | OXZ |
| Sep 17, 2019 | K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Proce Amd Medicom, Inc., CA | OXZ |
| Oct 7, 2016 | K160100 | Prestige Ameritech Pediatric/Childs Face mask Prestige Ameritech | OXZ |
| May 4, 2012 | K113340 | KIMBERLY-CLARK CHILD'S FACEMASK Kimberly-Clark | OXZ |
| Sep 23, 2011 | K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK Kimberly-Clark | OXZ |
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