Panels › General, Plastic Surgery › Product code FXX · Class 2
Mask, Surgical
Regulation 878.4040
7510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in FXX
| Company | 510(k)s | Recalls |
|---|---|---|
| Tecnol New Jersey Wound Care, Inc. | 11 | 0 |
| Owens & Minor (O&M) Halyard, Inc. | 8 | 0 |
| Anago, Inc. | 7 | 0 |
| Protectaide, Inc. | 7 | 0 |
| 3M Company | 6 | 0 |
| Guangdong Kingfa Sci. & Tech.Co., Ltd. | 6 | 0 |
| AMD Medicom Inc. | 0 | 5 |
| Tecnol Medical Products, Inc. | 5 | 0 |
| Dukal Corp. | 4 | 0 |
| Kimberly-Clark | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 2021 | K203776 | Surgical Masks, Model SNN200640 & MN112 Sq Medical Supplies, Inc. | FXX |
| Mar 25, 2021 | K202824 | BRS Procedure Face Mask Blackbriar Regulatory Services, LLC | FXX |
| Mar 25, 2021 | K202133 | Disposable Medical Mask Hangzhou Qianzhiya Sanitary Products Co., Ltd., CN | FXX |
| Mar 24, 2021 | K202650 | Medical disposable face mask non sterile Guangdong Zhong Ling Industrial Group Co., Ltd., CN | FXX |
| Mar 23, 2021 | K203064 | ICU Health Surgical Mask Plastikon Industries | FXX |
| Mar 19, 2021 | K202628 | Disposable Medical Face Mask Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,, CN | FXX |
| Mar 19, 2021 | K201095 | Sovereign America Surgical Face Mask Homtex, Inc. | FXX |
| Mar 18, 2021 | K201624 | Spin Care Disposable Protective Mask Spintech, LLC | FXX |
| Mar 16, 2021 | K210487 | MIPLNI YK-244 Disposable Surgical Mask Hunan Yuankang Biological Technology Co., Ltd., CN | FXX |
| Mar 15, 2021 | K201924 | Single-Use Surgical Mask Qiqihar Hengxin Medical Supplies, Ltd., CN | FXX |
| Mar 15, 2021 | K201698 | Medical Surgical Mask Hangzhou Mycode Bio-Medicine Co., Ltd., CN | FXX |
| Mar 12, 2021 | K203775 | AIC disposable medical mask The Aleen International Corporation, CN | FXX |
| Mar 10, 2021 | K202548 | Surgical Face Mask Wanxinda (Guangzhou) Technology Product Co., Ltd., CN | FXX |
| Mar 10, 2021 | K202411 | Surgical Mask Allmed Medical Products Co., Ltd., CN | FXX |
| Mar 10, 2021 | K202161 | Surgical Face Mask Hunan Eexi Technology & Service Co., Ltd., CN | FXX |
| Mar 9, 2021 | K210181 | Nordiwell Surgical Face Mask Changzhou Combat Protective Equipment Co., Ltd., CN | FXX |
| Mar 9, 2021 | K202710 | Disposable Medical Face Mask Wanxinda (Guangzhou) Technology Product Co., Ltd., CN | FXX |
| Mar 9, 2021 | K202409 | Surgical Mask Allmed Medical Products Co., Ltd., CN | FXX |
| Mar 9, 2021 | K202205 | Surgical Face Mask Jiangsu Micsafe Medical Technology Co., Ltd., CN | FXX |
| Mar 8, 2021 | K202439 | Disposable Medical Face Mask Hunan Eexi Technology & Service Co., Ltd., CN | FXX |
| Mar 7, 2021 | K201974 | Single-use medical face mask Guangdong Horigen Mother & Baby Products Co., Ltd., CN | FXX |
| Mar 5, 2021 | K203425 | Surgical Mask Bdc Dental Corporation , Ltd., CN | FXX |
| Mar 4, 2021 | K210225 | Surgical Face Mask Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd., CN | FXX |
| Mar 4, 2021 | K202137 | Disposable medical mask U-Play Products Corporation, CN | FXX |
| Mar 3, 2021 | K202316 | Medical mask (Model: KKF-1A) Han Zhaoqing Sporting Goods Company Limited, CN | FXX |
| Mar 2, 2021 | K202214 | IFM Surgical Mask Model SM3 Fssc, LLC | FXX |
| Mar 2, 2021 | K201852 | Surgical Mask-Model Number: Ear Loop, Flat-Pleated Huizhou Foryou Medical Devices Co., Ltd., CN | FXX |
| Feb 25, 2021 | K203524 | Surgical Masks Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FXX |
| Feb 25, 2021 | K202240 | Disposable Surgical Mask/Fluid Resistant Procedure Mask Lhm Medical Technology (Hong Kong) Limited, CN | FXX |
| Feb 22, 2021 | K201868 | Phyziofit Medical Surgical Mask Wellpower Sporting Goods Co., Ltd., CN | FXX |
| Feb 19, 2021 | K201182 | iMask Disposable Surgical Face Mask Pac-Dent, Inc. | FXX |
| Feb 18, 2021 | K203426 | Surgical Face Mask (non-sterile) Nantong Taiweishi Medical Technology Co., Ltd., CN | FXX |
| Feb 16, 2021 | K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On Dukal Corporation | FXX |
| Feb 12, 2021 | K202341 | Disposable Surgical Mask Shanghai Jianzhong Medical Packaging Co., Ltd., CN | FXX |
| Feb 12, 2021 | K201545 | Surgical Face Mask Amphastar Nanjing Pharmaceuticals, Inc., CN | FXX |
| Feb 10, 2021 | K202605 | Standard Procedure Mask, Standard Surgical Mask Jiangsu Medplus Non-Woven Manufacturer Co., Ltd., CN | FXX |
| Feb 9, 2021 | K203265 | nPro Surgical Mask Np Medical, Inc. | FXX |
| Feb 5, 2021 | K210063 | Freudenberg Surgical Mask Freudenberg Performance Materials LP | FXX |
| Feb 5, 2021 | K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Dukal Corporation | FXX |
| Feb 4, 2021 | K202493 | Medical Face Mask Gemtier Medical (Shanghai), Inc., CN | FXX |
| Feb 3, 2021 | K202627 | Medical Face Masks Guilin Hbm Sanitary Protections, Inc., CN | FXX |
| Feb 2, 2021 | K202511 | Disposable Medical Surgical Mask Improve Medical (Hunan) Co., Ltd., CN | FXX |
| Feb 2, 2021 | K202331 | Medical Face Mask Gemtier Medical (Shanghai), Inc., CN | FXX |
| Feb 2, 2021 | K202323 | Disposable Medical Surgical Masks Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd., CN | FXX |
| Feb 2, 2021 | K202096 | 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On Ecoguard, Inc. | FXX |
| Jan 29, 2021 | K202358 | Protective Face Mask for Medical Use Hunan Heng Chang Pharmaceutical Co., Ltd., CN | FXX |
| Jan 22, 2021 | K202640 | Surgical Mask Jiangsu Medpure Biological Technology Co., Ltd., CN | FXX |
| Jan 21, 2021 | K202904 | Surgical Face Mask Jiangxi Feilikang Medical Technology Co., Ltd., CN | FXX |
| Jan 21, 2021 | K202595 | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask Premier Guard USA, LLC | FXX |
| Jan 15, 2021 | K202107 | Medical Protective Mask Guangdong Kingfa Sci. & Tech.Co., Ltd., CN | FXX |
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