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 |
|---|---|---|---|
| Apr 25, 2022 | K220512 | Disposable Surgical Face Mask (M01, M02) Fomed Industries, Inc., CN | FXX |
| Apr 7, 2022 | K212203 | Dong Hai Xiang Surgical Mask Taizhou Donghaixiang Protective Equipment Co., Ltd., CN | FXX |
| Apr 7, 2022 | K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 Gri-Alleset, Inc. | FXX |
| Apr 6, 2022 | K214085 | Disposable Medical Mask Hubei Wanli Protective Products Co., Ltd., CN | FXX |
| Apr 5, 2022 | K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) Guangdong Kingfa Sci. & Tech.Co., Ltd., CN | FXX |
| Mar 31, 2022 | K213736 | Medical Face Mask Hangzhou Runheng Medical Co., Ltd., CN | FXX |
| Mar 30, 2022 | K210422 | INTAI Surgical Mask (non-sterile) Intai Technology Corp., TW | FXX |
| Mar 25, 2022 | K220637 | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask Kdi Med Supply | FXX |
| Mar 25, 2022 | K220187 | Medical Surgical Mask (Model: JM92, JM92B) Guangdong Jia Mei Biological Technology Co.Ltd, CN | FXX |
| Mar 24, 2022 | K202903 | Surgical Face Mask Rizhao Sanqi Medical & Health Articles Co., Ltd., CN | FXX |
| Mar 23, 2022 | K212726 | Disposable Medical Surgical Mask Hubei Huaqiang High-Tech Co., Ltd., CN | FXX |
| Mar 14, 2022 | K213894 | DWFritz ASM2000 Dwfritz Automation, Inc. | FXX |
| Mar 14, 2022 | K212330 | Yadu Medical Face Mask (Level 1) Henan Yadu Industrial Co., Ltd., CN | FXX |
| Mar 12, 2022 | K213806 | Disposable Medical Face Mask Xiantao Zhibo Nonwoven Products Co., Ltd., CN | FXX |
| Mar 8, 2022 | K214087 | Medical Face Mask Hubei Medlink Healthcare Co., Ltd., CN | FXX |
| Mar 4, 2022 | K213358 | Surgical Mask Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd., CN | FXX |
| Mar 2, 2022 | K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G Medtecs (Taiwan) Corp., TW | FXX |
| Feb 24, 2022 | K214094 | ROKI Surgical Mask Roki Co., Ltd., JP | FXX |
| Feb 20, 2022 | K213724 | Medical Surgical Mask Hunan Zhenheyikang Medical Instrument Co., Ltd., CN | FXX |
| Feb 19, 2022 | K212863 | Surgical Face Mask Taiwan Comfort Champ Manufacturing Co., Ltd., TW | FXX |
| Feb 19, 2022 | K212366 | Heartland Health Surgical Mask Heartland Health Products | FXX |
| Feb 11, 2022 | K213617 | Surgical Face Mask Megasoft (China) Co., Ltd., CN | FXX |
| Jan 28, 2022 | K212120 | Surgical Masks Hubei Xinxin Non-Woven Co., Ltd., CN | FXX |
| Jan 26, 2022 | K212610 | Surgical Face Mask Foshan Nanhai Plus Medical Co, Ltd., CN | FXX |
| Jan 26, 2022 | K210101 | American-Made Surgical Mask Armbrust, Inc. | FXX |
| Jan 25, 2022 | K213347 | ADI Medical Surgical Face Mask Asia Dynamics Inc., D/B/A Adi Medical | FXX |
| Jan 23, 2022 | K213970 | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply Danameco Medical Joint Stock Corporation, VN | FXX |
| Jan 23, 2022 | K212111 | Myflon Surgical Mask Level 3 Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi, TR | FXX |
| Jan 20, 2022 | K203161 | Surgical Face Mask Wuhan Raytex Protection Co., Ltd., CN | FXX |
| Jan 19, 2022 | K212826 | Disposable Medical Mask Jiangsu Nanfang Medical Co., Ltd., CN | FXX |
| Jan 18, 2022 | K210679 | Medical Face Mask Wuxi Yushou Medical Appliances Co., Ltd., CN | FXX |
| Jan 17, 2022 | K212994 | Medical Face Mask Guangzhou Quantum Laser Intelligent Equipment Co., Ltd., CN | FXX |
| Jan 16, 2022 | K213920 | Kangbeier Surgical Mask (Model: KBR-1001) Xinxiang Kangbeier Medical Technology Co., Ltd., CN | FXX |
| Jan 16, 2022 | K211833 | Disposable Medical Face Mask Zhejiang the Purples Protective Products Co.,Ltd, CN | FXX |
| Jan 14, 2022 | K212997 | Surgical Mask Guangdong Zhizhen Biological Medical Co., Ltd., CN | FXX |
| Jan 14, 2022 | K212913 | Surgical Face Mask Jiangxi Ganlong Pharmaceutical Co., Ltd., CN | FXX |
| Jan 10, 2022 | K211260 | Sheng Jing Tang Surgical Mask Liaoning Shengjingtang Biotechnology Co., Ltd., CN | FXX |
| Jan 4, 2022 | K212375 | Disposable Medical Surgical Mask Jiangxi Bestgrand Health Technology Co., Ltd., CN | FXX |
| Jan 4, 2022 | K212299 | Medical Surgical Mask Wepon Medical Technology Co., Ltd., CN | FXX |
| Dec 24, 2021 | K213136 | CPL Surgical Face Mask Control Print Limited, IN | FXX |
| Dec 24, 2021 | K202255 | Skypro, SP02 Mask (3) Skypro Medical Supplies Company, CN | FXX |
| Dec 22, 2021 | K210147 | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield Unicoglobal, Inc., KR | FXX |
| Dec 20, 2021 | K211750 | Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) National Bridge Industrial (S.Z.) Co., Ltd., CN | FXX |
| Dec 17, 2021 | K212059 | Surgical Face Mask Zhongshan Saifute Labor Protective Articles Co., Ltd., CN | FXX |
| Dec 17, 2021 | K210102 | Topwide Surgical Face Mask Topwide (Hubei) Medical Products Manufacturer, CN | FXX |
| Dec 16, 2021 | K211378 | LM Surgical Mask Level 3, LM Surgical Mask Level 2, Liberty Mask, LLC | FXX |
| Dec 15, 2021 | K212944 | Disposable Surgical Mask Heilongjiang Yinjia Medical Equipment Co., Ltd., CN | FXX |
| Dec 15, 2021 | K212398 | Surgical Face Mask (Non-sterile) Hubei Kimsoul Industrial Co., Ltd., CN | FXX |
| Dec 14, 2021 | K212574 | Surgical Face Mask Xiantao Deming Healthcare Products Co., Ltd., CN | FXX |
| Dec 14, 2021 | K210744 | Surgical Mask Chongqing PA Xijia Biotechnology Co., Ltd., CN | FXX |
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