注：
列表页默认显示“上市前通知”检索项下的内容；
上市前通知（510(K)）是指通过对拟上市产品与已上市产品在安全性和有效性方面进行比较，在得出实质性等同（Substantial Equivalence，简称SE）结论的前提下，进而获得拟上市产品可以合法销售的上市前通告的一条法规路径，适合于第一类、第二类、少部分三类医疗器械。
上市前批准（PMA）是FDA按照科学性和法规要求，评价第三类医疗器械安全性和有效性的审批程序。
| 器械名称 | 申请人 | 510K号码 | 类型 | 医学分类 | 收到日 | 决定日 |
|---|---|---|---|---|---|---|
| HMB32 Dialysis Solution | Via dell'Industria 6 | K212052 | Special | GU | 2021-06-30 | 2021-07-23 |
| Flex-Thread Distal Fibula lntramedullary Nail System | 100 Witmer Road | K212030 | Special | OR | 2021-06-29 | 2021-07-23 |
| Reveal LINQ Insertable Cardiac Monitor | 8200 Coral Sea Street NE | K212008 | Special | CV | 2021-06-28 | 2021-07-22 |
| MASC Surgical Mask | 800 Greenleaf Avenue | K211984 | Traditional | SU | 2021-06-25 | 2021-07-25 |
| NIO+ Adult | 10 Amal St. Afek Industrial Park | K211968 | Special | HO | 2021-06-24 | 2021-07-22 |
| CD Horizon Spinal System | 1800 Pyramid Place | K211958 | Special | OR | 2021-06-24 | 2021-07-21 |
| Medline UNITE® Digital Fusion Screw System | Three L akes Drive | K211944 | Special | OR | 2021-06-23 | 2021-07-22 |
| ExacTrac Dynamic | Olof-Palme-Str. 9 | K211939 | Special | RA | 2021-06-23 | 2021-07-22 |
| Soniquence Reusable Bipolar Cable | 2477 Grand Avenue | K211946 | Special | SU | 2021-06-23 | 2021-07-16 |
| Physica LMC Knee System | Via Nazionale, 52 | K211938 | Special | OR | 2021-06-23 | 2021-07-13 |
| GI Genius | Riverside II, Sir John Rogersons Quay | K211951 | Special | GU | 2021-06-23 | 2021-07-23 |
| EleVation Breast Biopsy System | 1625 W. 3rd Street | K211933 | Special | GU | 2021-06-22 | 2021-07-15 |
| Vital Signs | Magdalen Centre North, The Oxford Science Park | K211906 | Special | CV | 2021-06-21 | 2021-07-20 |
| Z-6 Atrioseptostomy Catheter | 2880 Main Street | K211910 | Special | CV | 2021-06-21 | 2021-07-19 |
| MolecuLightDX | Suite 700, 425 University Avenue | K211901 | Special | SU | 2021-06-21 | 2021-07-21 |
| Bencox THR System | 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu | K211866 | Special | OR | 2021-06-16 | 2021-07-14 |
| ACUSON Sequoia Diagnostic Ultrasound System | 22010 South East 51st Street | K211859 | Traditional | RA | 2021-06-16 | 2021-07-20 |
| DEKA Motus AZ | Via Baldanzese 17 | K211821 | Special | SU | 2021-06-11 | 2021-07-06 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | 530 Old Whitfield Street | K211818 | Special | RA | 2021-06-11 | 2021-07-07 |
| StitchKit | 42 Main St. | K211792 | Special | SU | 2021-06-10 | 2021-07-16 |
