| 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 |
