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 |
|---|---|---|---|
| Sep 8, 2021 | K211832 | Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask Zhejiang Lanhine Medical Products, Ltd., CN | FXX |
| Sep 3, 2021 | K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) Altor Safety, LLC | FXX |
| Sep 1, 2021 | K211536 | Welspun Health Surgical Mask Welspun India Limited, IN | FXX |
| Aug 28, 2021 | K211255 | Surgical Mask Tianchang Kanghui Protective Products Co, Ltd., CN | FXX |
| Aug 27, 2021 | K202746 | Surgical mask Ningbo Jingeao Electronics, Inc., CN | FXX |
| Aug 25, 2021 | K211451 | Disposable Surgical Mask (non sterile) Qinhuangdao Taizhi Medical Technology Co., Ltd., CN | FXX |
| Aug 23, 2021 | K202745 | Disposable medical face mask Ningbo Jingeao Electronics, Inc., CN | FXX |
| Aug 19, 2021 | K211576 | WYZ Surgical Mask Wyz Medical Supplies, LLC | FXX |
| Aug 19, 2021 | K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask Xiantao S&J Protective Products Co., Ltd., CN | FXX |
| Aug 19, 2021 | K211066 | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 Homtex, Inc. | FXX |
| Aug 19, 2021 | K210698 | ECOMA Level 2 Disposable Surgical Mask with Ear Loops Xianning Eco Medical Articles Co., Ltd., CN | FXX |
| Aug 19, 2021 | K210256 | CiRx (R) Surgical Mask Ningbo Shun YE Medical Company, Ltd., CN | FXX |
| Aug 18, 2021 | K212097 | Disposable medical surgical mask Hebei Titans Hongsen Medical Technology Co., Ltd., CN | FXX |
| Aug 18, 2021 | K211631 | Surgical Face Mask Macheng Thimble Technology Investment Co., Ltd., CN | FXX |
| Aug 18, 2021 | K211454 | Surgical mask Jiangsu Xingtong Biotechnology Group Co., Ltd., CN | FXX |
| Aug 11, 2021 | K211552 | Surgical mask Shandong Shengquan New Materials Co., Ltd., CN | FXX |
| Aug 11, 2021 | K211353 | Medical Face Mask Shenzhen Lyttop Healthcare Limited, CN | FXX |
| Aug 11, 2021 | K203152 | Disposable Face Mask Chaozhou Cecilia Technology Co., Ltd., CN | FXX |
| Aug 4, 2021 | K210643 | Disposable Surgical Face Mask Shandong Zhushi Pharmaceutical Group Co., Ltd., CN | FXX |
| Aug 3, 2021 | K211897 | Surgical Face Mask Zhejiang Hongyu Medicali Commodity Co., Ltd., CN | FXX |
| Aug 2, 2021 | K203174 | Disposable Medical Mask Dong Guan Kinyet Metal Products Co., Ltd., CN | FXX |
| Jul 30, 2021 | K210870 | MEO Med Disposable Medical Face Mask Fujian Meo Medical Technology Limited, CN | FXX |
| Jul 28, 2021 | K211861 | TAIJI Professional Series Level 3 Surgical Face Mask Taiji Medical Supplies, Inc. | FXX |
| Jul 28, 2021 | K211497 | Surgical Mask Honeywell Safety Products | FXX |
| Jul 28, 2021 | K210856 | Purism Disposable Surgical Mask Chuzhou Daddy'S Choice Science and Technology Co., Ltd., CN | FXX |
| Jul 28, 2021 | K210409 | Disposable Surgical Face Mask Shandong Zhushi Pharmaceutical Group Co., Ltd., CN | FXX |
| Jul 25, 2021 | K211984 | MASC Surgical Mask Mid-America Safety Corp. | FXX |
| Jul 24, 2021 | K211363 | Medical Face Mask Hubei Kangning Protective Products Co., Ltd., CN | FXX |
| Jul 23, 2021 | K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) Altor Safety, LLC | FXX |
| Jul 22, 2021 | K210391 | Single-use medical face mask Zhuhai Herald Datanetics Limited., CN | FXX |
| Jul 21, 2021 | K210970 | Single-Use Surgical Mask Model FE2311B Byd Precison Manufacturer Co., Ltd., CN | FXX |
| Jul 21, 2021 | K203534 | Surgical face mask (Model: Flat Ear Loop/CN102) Crown Name Disposable Hygiene Products Fty., Ltd., CN | FXX |
| Jul 16, 2021 | K210761 | Velguard Surgical Face Mask Esstee Exports Health Care Division, IN | FXX |
| Jul 15, 2021 | K211042 | Disposable Procedural Ear-loop Face Mask Changzhou Dsb Medical Co., Ltd., CN | FXX |
| Jul 14, 2021 | K201844 | Surgical Face Mask, Surgical Mask Lear Corporation | FXX |
| Jul 12, 2021 | K210244 | Disposable Medical Face Mask Suzhou Bolisi Medical Technology Co., Ltd., CN | FXX |
| Jul 8, 2021 | K210380 | Medical surgical mask Shantou T&K Medical Equipment Factory Co.,Ltd, CN | FXX |
| Jul 8, 2021 | K210267 | Disposable Surgical Mask Xiamen Eagledon Pharmaceutical Co., Ltd., CN | FXX |
| Jul 7, 2021 | K210524 | Surgical Mask Changzhou Holymed Products Co., Ltd., CN | FXX |
| Jul 2, 2021 | K203591 | Single-use Medical Face Mask Conod Medical Co., Limited, CN | FXX |
| Jul 2, 2021 | K202954 | Disposable Surgical Mask Xiamen Probtain Medical Techology Co., Ltd., CN | FXX |
| Jun 29, 2021 | K210445 | Nordiwell Surprotect Face Mask Changzhou Combat Protective Equipment Co., Ltd., CN | FXX |
| Jun 22, 2021 | K210840 | Disposable Surgical Mask Safeway Industry Healthcare., CN | FXX |
| Jun 16, 2021 | K203200 | Disposable Medical Surgical Face Mask Guangdong Haiou Medical Apparatus Co., Ltd., CN | FXX |
| Jun 15, 2021 | K211520 | Amerishield Surgical Mask Premiumestore, LLC | FXX |
| Jun 14, 2021 | K210518 | Surgical Face Mask Shandong Haidike Medical Products Co., Ltd., CN | FXX |
| Jun 11, 2021 | K203732 | Surgical Face Mask Zhuhai Gaoge Medical Technology Co., Ltd., CN | FXX |
| Jun 11, 2021 | K202714 | Medical Face Mask Chongqing Chaoke Industry Development Co., Ltd., CN | FXX |
| Jun 10, 2021 | K210767 | Surgical Masks, Model:FE-1 Hunan Triplex Precision Medical Devices Co., Ltd., CN | FXX |
| Jun 10, 2021 | K210015 | Surgical Face Mask Sample King Manufacturing, Ltd., CN | FXX |
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