| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006) | Ge Medical Systems, Inc. | 2001-11-09 |
| COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001) | Ge Medical Systems Information Technologies | 2001-11-09 |
| LASERSCAN LSX EXCIMER LASER SYSTEM (P980008/S009) | Lasersight Technologies, Inc. | 2001-11-09 |
| IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (P010007) | Siemens Healthcare Diagnostics, Inc. | 2001-11-09 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S031) | Dade Intl., Inc. | 2001-11-09 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S003) | Covidien, LLC | 2001-11-09 |
| HALL (TM) EASY-FIT PROSTHETIC HEART VALVE (P790018/S037) | Medtronic Cardiac Surgery | 2001-11-09 |
| MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM (P990016/S001) | CooperSurgical, Inc. | 2001-11-08 |
| MAVERICK OVER THE WIRE PTCA CAHTHETER (P860019/S177) | Scimed Life Systems, Inc. | 2001-11-08 |
| APLIGRAF (GRAFTSKIN) (P950032/S027) | Organogenesis, Inc. | 2001-11-07 |
| SALINE-FILLED BREAST IMPLANTS (P990074/S004) | Allergan | 2001-11-07 |
| APLIGRAF (GRAFTSKIN) (P950032/S020) | Organogenesis, Inc. | 2001-11-07 |
| VISX STAR EXCIMER LASER SYSTEM (P930016/S014) | Amo Manufacturing USA, LLC | 2001-11-06 |
| DIAGNOSTIC DUETT (P990037/S001) | Vascular Solutions, Inc. | 2001-11-02 |
| MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD (P920015/S024) | Medtronic, Inc. | 2001-11-02 |
| FOCALPOINT SYSTEMCREENING SYSTEM (P950009/S005) | Bd Diagnostics | 2001-11-02 |
| PREPSTAIN SYSTEM (P970018/S003) | Bd Diagnostic Systems | 2001-11-02 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052) | Guidant Corp. | 2001-11-02 |
| ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S007) | Cryolife, Inc. | 2001-11-01 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S017) | Medtronic Neuromodulation | 2001-11-01 |
| FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS (P970031/S010) | Medtronic, Inc. | 2001-10-31 |
| MEDTRONIC KAPPA 700/600 PULSE GENERATOR (P980035/S015) | Medtronic, Inc. | 2001-10-31 |
| FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS (P990009/S011) | Baxter Healthcare Corp | 2001-10-31 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S005) | Vascular Solutions, Inc. | 2001-10-31 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S013) | Thoratec Laboratories Corp. | 2001-10-31 |
| MENTOR SALINE-FILLED MAMMARY PROSTHESES (P990075/S005) | Mentor Worldwide, LLC | 2001-10-31 |
| VIBRANT SOUNDBRIDGE SYSTEM (P990052/S006) | Med-El Elektromedizinische Gerate GmbH | 2001-10-26 |
| BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 (P920032/S007) | Pace Medical | 2001-10-26 |
| AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE (P950037/S022) | Biotronik, Inc. | 2001-10-26 |
| VENTAK PRIZM II AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM (P960040/S024) | Boston Scientific | 2001-10-26 |
| THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS (P960004/S019) | Boston Scientific | 2001-10-26 |
| PROSORBA COLUMN (P850020/S013) | Fresenius Hemocare, Inc. | 2001-10-26 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S009) | Best Vascular, Inc. | 2001-10-26 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S008) | Best Vascular, Inc. | 2001-10-26 |
| LASERSCAN LSX EXCIMER LASER SYSTEM (P980008/S008) | Lasersight Technologies, Inc. | 2001-10-25 |
| MICRONY PULSE GENERATORS (P970013/S002) | ABBOTT MEDICAL | 2001-10-25 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S007) | Animas Corp. | 2001-10-25 |
| REGENCY SC+ PULSE GENERATORS (P880006/S034) | St. Jude Medical, Inc. | 2001-10-25 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S014) | Medtronic Neuromodulation | 2001-10-24 |
| MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) (P900061/S048) | Medtronic Cardiac Rhythm Disease Management | 2001-10-24 |
| MEDTRONIC JEWEL AF ICD (P980050/S009) | Medtronic, Inc. | 2001-10-24 |
| GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S022) | Medtronic Cardiac Rhythm Disease Management | 2001-10-24 |
| DEMA/DIVA IMPLANTABLE PULSE GENERATORS (P990001/S008) | Medtronic, Inc. | 2001-10-24 |
| INSYNC IMPLANTABLE PULSE GENERATORS, MODEL 8040 (P010015/S001) | Medtronic, Inc. | 2001-10-24 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS (P980035/S012) | Medtronic, Inc. | 2001-10-24 |
| ACHILLES INSIGHT ULTRASONOMETER (P970040/S002) | Ge Lunar Corp. | 2001-10-24 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTEROIR CHAMBER INTRAOCULAR LENS (IOL) (P980040/S002) | Johnson & Johnson Surgical Vision, Inc. | 2001-10-24 |
| KAPPA 400 IMPLANTABLE PULSE GENERATOR (P970012/S011) | Medtronic, Inc. | 2001-10-24 |
| TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS (P980023/S005) | Biotronik, Inc. | 2001-10-24 |
| BIODIVYSIO AS OTW (P000011/S005) | Abbott Vascular, Inc. | 2001-10-22 |
| THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S005) | Gynecare, Inc. | 2001-10-19 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S021) | Medtronic, Inc. | 2001-10-19 |
| HYDROVIEW COMPOSITE HYDROGEL FOLDABLE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P990014/S001) | Bausch & Lomb, Inc. | 2001-10-19 |
| BETA-CATH(TM) SYSTEM (P000018/S013) | Best Vascular, Inc. | 2001-10-18 |
| VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146) | Biomerieux Vitek, Inc. | 2001-10-17 |
| SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A (P990080/S001) | Johnson & Johnson Surgical Vision, Inc. | 2001-10-16 |
| BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM (RX) (P900043/S029) | Cordis Corp. | 2001-10-16 |
| CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S056) | ABBOTT MEDICAL | 2001-10-15 |
| FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P000030) | Alcon Laboratories, Inc. | 2001-10-12 |
| COBAS AMPLICOR HCV TEST, V2.0 (P000012/S001) | Roche Molecular Systems, Inc. | 2001-10-12 |
| COBAS AMPLICOR HCV TEST, V2.0 (P000010/S001) | Roche Molecular Systems, Inc. | 2001-10-12 |
| INTACS PRESCRIPTION INSERTS (P980031/S004) | Addition Technology | 2001-10-11 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019) | Alcon Laboratories, Inc. | 2001-10-11 |
| HOME MONITORING SYSTEM (P950037/S019) | Biotronik, Inc. | 2001-10-11 |
| BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR (P850022/S013) | Ahp Eos Buyer, Inc. | 2001-10-10 |
| BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE (P950037/S020) | Biotronik, Inc. | 2001-10-10 |
| GEM VR MODELS 7227 B/D/E/CX (P900061/S047) | Medtronic Cardiac Rhythm Disease Management | 2001-10-10 |
| STINGER SM ABLATION CATHETER (P000020/S004) | Boston Scientific Corp | 2001-10-10 |
| CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S020) | Spectranetics Corp. | 2001-10-10 |
| RF CONTACTR ABLATION CATHETER (P930029/S015) | Medtronic, Inc. | 2001-10-09 |
| CLOSER/CLOSER S SMC 6 FRENCH SYSTEMS (P960043/S029) | Abbott Vascular, Inc. | 2001-10-09 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S001) | Covidien, LLC | 2001-10-05 |
| AUTOPAP PRIMARY SCREENING SYSTEM (P950009/S004) | Bd Diagnostics | 2001-10-05 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S010) | Biosense Webster, Inc. | 2001-10-05 |
| S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S029) | Medtronic, Ireland | 2001-10-04 |
| SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK (P950034/S018) | Baxter Healthcare Corporation | 2001-10-04 |
| PERI-OSS (P800035/S010) | Curasan AG | 2001-10-04 |
| LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP (P960016/S007) | St Jude Medical | 2001-10-04 |
| PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR (P940013/S007) | Alcon Laboratories, Inc. | 2001-10-04 |
| LCS TOTAL KNEE SYSTEM (P830055/S080) | Depuy, Inc. | 2001-10-03 |
| S7/S670/S660/BESTENT WITH DISCRETE TECHNOLOGY (TM) RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S030) | Medtronic, Ireland | 2001-10-02 |
| INTEGRITY AFX DR MODEL 5346 (P830045/S078) | St. Jude Medical, Inc. | 2001-10-02 |
| 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S032) | Terumo Medical Corporation | 2001-10-02 |
| INTEGRITY AFX DR MODEL 5346 (P880086/S085) | ABBOTT MEDICAL | 2001-10-02 |
| S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S008) | Medtronic Vascular | 2001-10-02 |
| PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER (P910023/S055) | ABBOTT MEDICAL | 2001-10-02 |
| SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S006) | GE Healthcare | 2001-10-01 |
| PORT-A-CATH EPIDURAL SYSTEMS (P900052/S009) | Smiths Medical Asd, Inc. | 2001-10-01 |
| LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK) (P980008/S005) | Lasersight Technologies, Inc. | 2001-09-28 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013) | Hologic, Inc. | 2001-09-28 |
| SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S020) | Baxter Healthcare Corporation | 2001-09-28 |
| DERMAGRAFT (P000036) | Shire Regenerative Medicine | 2001-09-28 |
| VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001) | Carl Zeiss Meditec, AG | 2001-09-27 |
| COHERENT OPAL PHOTOACTIVATOR (P990049/S001) | Lumenis | 2001-09-27 |
| RAPTORAIL PTCA DILATATION CATHETER (P880003/S082) | Cordis Corp. | 2001-09-27 |
| NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER (P990025/S002) | Biosense Webster, Inc. | 2001-09-26 |
| TVL LEAD SYSTEM (P950022/S013) | ABBOTT MEDICAL | 2001-09-26 |
| NOVOSTE (TM) BETA-CATH(TM) SYSTEM (P000018/S017) | Best Vascular, Inc. | 2001-09-26 |
| NIR STENT DELIVERY SYSTEMS (P980001/S038) | Boston Scientific Corp | 2001-09-26 |
| BESTENT (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S007) | Medtronic Vascular | 2001-09-26 |