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 |
|---|---|---|---|---|---|---|
| CAST MATERIAL (WICKET STOCKINETTE) | ZIMMER, INC. | K760003 | Traditional | PM | 1976-05-26 | 1976-07-26 |
| ARCH SUPPORT (ARCH AID) | ZIMMER, INC. | K760001 | Traditional | 1976-05-26 | 1976-07-26 | |
| KNEE AID | ZIMMER, INC. | K760002 | Traditional | PM | 1976-05-26 | 1976-07-26 |
| SYRINGE, DISPOSABLE, GLASS & PLASTIC | STEWART-NAUMANN LABORATORIES | K760005 | Traditional | HO | 1976-06-07 | 1976-08-23 |
| SYRINGE, DISPOSABLE, ALL PLASTIC | STEWART-NAUMANN LABORATORIES | K760004 | Traditional | HO | 1976-06-07 | 1976-08-23 |
| RADIOASSAY, CONCEPT 4 | MICROMEDIC SYSTEMS | K760006 | Traditional | 1976-06-07 | 1976-07-20 | |
| BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | GEOMETRIC DATA, DIV. SMITHKLINE CORP. | K760007 | Traditional | HE | 1976-06-08 | 1976-09-03 |
| DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL | KYOCERA INTERNATIONAL, INC. | K760008 | Traditional | DE | 1976-06-08 | 1976-10-05 |
| PACER SYSTEMS ANALYZER (CORDIS) | CORDIS CORP. | K760013 | Traditional | CV | 1976-06-10 | 1976-07-20 |
| COLORIMETRIC DETERMINATION (SGOT/SGPT) | THE DOW CHEMICAL CO. | K760010 | Traditional | CH | 1976-06-10 | 1976-07-26 |
| COLORIMETRIC DETERMINATION (LDH) | THE DOW CHEMICAL CO. | K760009 | Traditional | CH | 1976-06-10 | 1976-07-20 |
| REAGENT, TRIGLYCERIDES | THE DOW CHEMICAL CO. | K760011 | Traditional | CH | 1976-06-10 | 1976-07-26 |
| BLOOD WARMER (CODE 4R4305) | TRAVENOL LABORATORIES, S.A. | K760012 | Traditional | HE | 1976-06-10 | 1976-07-16 |
| VACUUM TUBES, PEDIATRIC SIZES (J-VAC) | JELCO LABORATORIES | K760019 | Traditional | CH | 1976-06-11 | 1976-07-20 |
| CONSIOUS SEDATION (ANALOR P-76) | MCKESSON CORP. | K760017 | Traditional | AN | 1976-06-11 | 1976-07-20 |
| SURGICAL BLADES (BEAVER) | PARKE-DAVIS CO. | K760016 | Traditional | 1976-06-11 | 1976-07-16 | |
| VACUUM TUBES, STERILE (J-VAC) | JELCO LABORATORIES | K760018 | Traditional | CH | 1976-06-11 | 1976-07-20 |
| ULTRAZYME HBD | HARLECO | K760023 | Traditional | CH | 1976-06-14 | 1976-08-26 |
| ULTRAZYME ALKALINE PHOSPHATASE | HARLECO | K760024 | Traditional | CH | 1976-06-14 | 1976-08-26 |
| NEEDLE, FILTER | JELCO LABORATORIES | K760022 | Traditional | SU | 1976-06-14 | 1976-08-09 |
