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 |
|---|---|---|---|
| Dec 13, 2022 | K222651 | Surgical Face Mask Xiantao Sanda Industrial Co., Ltd., CN | FXX |
| Dec 7, 2022 | K223045 | 3-Ply Disposable Medical Mask Wealth Lead Industrial Limited, CN | FXX |
| Dec 5, 2022 | K223055 | Disposable Medical Face Mask Xiantao Zhuobo Industrial Co., Ltd., CN | FXX |
| Nov 23, 2022 | K223068 | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) Guangdong Golden Leaves Technology Development Co., Ltd., CN | FXX |
| Nov 18, 2022 | K223003 | Banded Face Mask Hubei Medlink Healthcare Co., Ltd., CN | FXX |
| Nov 16, 2022 | K220302 | Disposable surgical face mask Shandong Aida Medical Products Co., Ltd., CN | FXX |
| Nov 16, 2022 | K203528 | KNH Surgical Face Mask Knh Surgical Face Mask, TW | FXX |
| Nov 14, 2022 | K222749 | High Fluid-Resistant Surgical and Procedure Mask AmericaS Supply Chains | FXX |
| Nov 14, 2022 | K222529 | Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd., CN | FXX |
| Nov 10, 2022 | K222551 | Humask Pro Vision, Humask Pro Vision 3000 Entreprise Premont, Inc., CA | FXX |
| Nov 4, 2022 | K222697 | Disposable Medical Face Mask (DF3-001) Wellmed Dental Medical Supply Co., Ltd., CN | FXX |
| Nov 1, 2022 | K223270 | POSE Health Care Surgical Mask America'S Supply Chains | FXX |
| Oct 25, 2022 | K212649 | Disposable Surgical Face Mask Lyncmed Medical Technology (Beijing) Co., Ltd., CN | FXX |
| Oct 11, 2022 | K222335 | Surgical Mask Luoyang Sunmed Devices Co., Ltd., CN | FXX |
| Sep 26, 2022 | K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) Jingzhou Haixin Green Cross Medical Products Co., Ltd., CN | FXX |
| Sep 23, 2022 | K222204 | Medical Surgical Mask Guangzhou Zhengkang Medical Equipment Co.,Ltd, CN | FXX |
| Sep 20, 2022 | K221976 | Surgical Face Mask (Non-sterile) Xiantao Junhui Plastic Products Co., Ltd., CN | FXX |
| Sep 16, 2022 | K221534 | Surgical Face Masks (Ear Loops And Tie-On) San-M Package Co., Ltd., JP | FXX |
| Sep 16, 2022 | K212926 | AllureTM Surgical Mask Allure Gift Wraps Private Limited, IN | FXX |
| Sep 13, 2022 | K214035 | LAITEST Medical Face Mask R&R Medical Corporation, Ltd., TW | FXX |
| Sep 9, 2022 | K220944 | PointCore Surgical Mask Pointcore, Inc. | FXX |
| Sep 2, 2022 | K222426 | Perfetta Moderate Medical Face Mask Phu Bao Group Company Limited, VN | FXX |
| Sep 2, 2022 | K221957 | Savewo ClassicMASK Savewo Limited, CN | FXX |
| Sep 1, 2022 | K221038 | Disposable Medical Masks Hantech Medical Device Co., Ltd., CN | FXX |
| Aug 30, 2022 | K220067 | Medical Surgery Mask, Model:2626-7 Dongguan Missadola Technology Co., Ltd., CN | FXX |
| Aug 24, 2022 | K211771 | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Gu The Good Corporation, KR | FXX |
| Aug 19, 2022 | K203078 | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW Huizhou Tianchang Industrial Co., Ltd., CN | FXX |
| Aug 17, 2022 | K221838 | Surgical Face Mask (HNFM0103) Shanghai Hua EN Industrial Co, Ltd., CN | FXX |
| Aug 17, 2022 | K212273 | Cross Protection ResQ300 Plus Surgical Face Mask Cross Protection (M) Sdn Bhd, MY | FXX |
| Jul 27, 2022 | K220876 | AOK 95A Medical Mask (20200049) Aok Tooling Limited, CN | FXX |
| Jul 25, 2022 | K221409 | Paneffort 3-ply Surgical and Procedural Masks Paneffort, LLC | FXX |
| Jul 22, 2022 | K221196 | Disposable Medical Face Mask (ear loop) Xiantao Topmed Nonwoven Protective Products Co., Ltd., CN | FXX |
| Jul 19, 2022 | K220777 | Surgical face mask Hubei Qianjiang Kingphar Medical Material Co., Ltd., CN | FXX |
| Jul 6, 2022 | K221173 | Surgical Mask (Model: 0868F, 0866F) Jiangxi Sanhao Medical Instruments Co.,Ltd, CN | FXX |
| Jun 30, 2022 | K220378 | Sparta 3-Ply Surgical Disposable Face Mask Sparta East, LLC | FXX |
| Jun 28, 2022 | K221273 | Medical Face Mask (M001) Xingyu Medical Tech Co., Ltd., CN | FXX |
| Jun 28, 2022 | K221272 | Medical Face Mask Shandong Xingyu Gloves Co., Ltd., CN | FXX |
| Jun 28, 2022 | K220670 | Magnum Magnum Health and Safety Pvt, Ltd., IN | FXX |
| Jun 24, 2022 | K220377 | Procedure Mask Little Rapids Corporation | FXX |
| Jun 14, 2022 | K220550 | Disposable Surgical Face Mask (M663BE, M663BT) Makrite Industries, Inc., TW | FXX |
| Jun 6, 2022 | K221222 | Surgical Face Mask (HNFM0304) Shanghai Hua EN Industrial Co, Ltd., CN | FXX |
| May 26, 2022 | K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) Qingdao Bestex Rubber & Plastic Products Co., Ltd., CN | FXX |
| May 24, 2022 | K220191 | Disposable Face Mask Jiujiang Taixin Technology Co., Ltd., CN | FXX |
| May 23, 2022 | K220532 | Disposable surgical mask Xiamen Blue Star Enterprise Co., Ltd., CN | FXX |
| May 19, 2022 | K221134 | Procedure Mask with Ear Loops and Surgical Mask with Ties Safesource Direct, LLC | FXX |
| May 19, 2022 | K220824 | Medical Surgical Mask (Planar type) Hunan Chopard Medical Devices Co., Ltd., CN | FXX |
| May 17, 2022 | K220194 | Procedure mask/Surgical mask/Face mask Winner Medical Co., Ltd., CN | FXX |
| May 13, 2022 | K220749 | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP Unimax Medical Products Co., Ltd., CN | FXX |
| May 11, 2022 | K213001 | Procedure Mask, Surgical Mask A Plus International, Inc. | FXX |
| Apr 26, 2022 | K220487 | Disposable Medical Face Mask Hubei Mediunion Medical Products Co., Ltd., CN | FXX |
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