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 |
|---|---|---|---|---|---|---|
| OHMEDA INOVENT DELIVERY SYSTEM | OHMEDA MEDICAL | DEN000001 | Post-NSE | AN | 2000-01-07 | 2000-01-11 |
| UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | UROSURGE, INC. | DEN000002 | Post-NSE | GU | 2000-01-27 | 2000-02-09 |
| QUICKAIR CHOKE RELIEVER, MODEL 59-001A | MAET INDUSTRIES, INC. | DEN000004 | Post-NSE | AN | 2000-01-28 | 2000-02-29 |
| EROS-CLITORAL THERAPY DEVICE (CTD) | UROMETRICS, INC. | DEN000006 | Post-NSE | OB | 2000-04-27 | 2000-04-28 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | INOVA DIAGNOSTICS, INC. | DEN000007 | Post-NSE | IM | 2000-07-18 | 2000-08-16 |
| DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | LIFE TECHNOLOGIES, INC. | DEN000008 | Post-NSE | GU | 2000-12-19 | 2001-02-16 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | BIOSITE INCORPORATED | DEN000010 | Post-NSE | CH | 2000-11-15 | 2000-11-20 |
| GIVEN DIAGNOSTIC IMAGING SYSTEM | GIVEN IMAGING LTD. | DEN010002 | Post-NSE | GU | 2001-06-11 | 2001-08-01 |
| BREASTVIEW VISUAL MAPPING SYSTEM | ASSURANCE MEDICAL | DEN020001 | Post-NSE | OB | 2002-05-28 | 2003-01-31 |
| RETROX | AURIC HEARING SYSTEMS, INC. | DEN020003 | Post-NSE | EN | 2002-06-21 | 2002-08-20 |
| NIOX ARTICLE NO: 02-1000 | AEROCRINE AB | DEN030001 | Post-NSE | TX | 2003-03-18 | 2003-04-30 |
| ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | SPECTRAL DIAGNOSTICS, INC. | DEN030002 | Post-NSE | MI | 2003-04-14 | 2003-06-16 |
| WEST NILE VIRUS IGM CAPTURE ELISA | PANBIO LIMITED | DEN030004 | Post-NSE | MI | 2003-07-03 | 2003-07-08 |
| FACTOR V LEIDEN KIT | ROCHE DIAGNOSTICS CORP. | DEN030005 | Post-NSE | HE | 2003-12-08 | 2003-12-17 |
| CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM | ADVANCED DIAGNOSTIC SYSTEMS | DEN040001 | Post-NSE | IM | 2004-01-02 | 2004-01-21 |
| NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 | PERKINELMER LIFE SCIENCES, INC. | DEN040002 | Post-NSE | CH | 2004-07-02 | 2004-08-24 |
| GLUCATELL | ASSOCIATES OF CAPE COD, INC. | DEN040003 | Post-NSE | MI | 2004-03-22 | 2004-05-21 |
| CELLERATION MIST THERAPY SYSTEM | CELLERATION | DEN040004 | Post-NSE | SU | 2004-04-29 | 2004-06-25 |
| VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER | DIGITAL ANGEL CORPORATION | DEN040007 | Post-NSE | HO | 2004-08-04 | 2004-10-12 |
| CEDIA SIROLIMUS ASSAY | MICROGENICS CORP. | DEN040008 | Post-NSE | TX | 2004-06-17 | 2004-07-28 |
