| SILIKON 1000 (P950008/S002) | Alcon | 2001-02-08 |
| DIASORIN ETI-EBK PLUS ASSAY (P990043) | DiaSorin, Inc. | 2001-02-08 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (NUCLEUS 24 CONTOUR COCHLEAR IMPLANT (P970051/S014) | Cochlear Americas | 2001-02-08 |
| STINGER(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE (P000020/S002) | Boston Scientific Corp | 2001-02-07 |
| LYRA(TM) ICD SYSTEMS (P970024/S004) | MicroPort CRM USA, Inc. | 2001-02-06 |
| INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY, 3080/3886 LEAD KITS (P970004/S011) | Medtronic Neuromodulation | 2001-02-05 |
| MEDSTONE STS LITHOTRIPTER (P970042/S001) | Medstone Intl., Inc. | 2001-02-05 |
| PHILOS PACING SYSTEM (P950037/S018) | Biotronik, Inc. | 2001-02-05 |
| MEDTRONIC MODEL 6725 PIN-PLUG FOR IS-1 PORT (P920015/S020) | Medtronic, Inc. | 2001-02-05 |
| HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS (P890014/S003) | DiaSorin, Inc. | 2001-02-02 |
| BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE (P950029/S013) | MicroPort CRM USA, Inc. | 2001-02-02 |
| EBK RIA ASSAY/ETI-EBK (P870048/S008) | Diasorin | 2001-02-02 |
| BX VELOCITY(TM) STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM (P900043/S025) | Cordis Corp. | 2001-02-02 |
| AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS (P890019/S006) | Diasorin | 2001-02-02 |
| THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM (P960043/S030) | Abbott Vascular, Inc. | 2001-02-02 |
| VENTAK(R) PRIZM(TM) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD-TM) SYSTEM (P960040/S020) | Boston Scientific | 2001-02-01 |
| ORCHESTRA PROGRAMMER (P980049/S004) | MicroPort CRM USA, Inc. | 2001-01-31 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S006) | Best Vascular, Inc. | 2001-01-29 |
| HEART LASER 2 (HL2) (P950015/S008) | Laser Engineering Heart, Inc. | 2001-01-29 |
| DIAPHAGMATIC/PHRENIC NERVE STIMULATOR (P860026/S007) | Avery Biomedical Devices, Inc. | 2001-01-26 |
| NIROYAL(R) ELITE PREMOUNTED STENT SYSTEM (P980001/S023) | Boston Scientific Corp | 2001-01-25 |
| SUPARTZ FX (P980044) | Seikagaku Corp. | 2001-01-24 |
| CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS (P810046/S205) | Advanced Cardiovascular Systems, Inc. | 2001-01-24 |
| VENTAK AV FOR ASTRID (P960040/S019) | Boston Scientific | 2001-01-23 |
| VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S009) | Boston Scientific | 2001-01-23 |
| VENTAK MINI IV (AICD) (P910077/S036) | Boston Scientific | 2001-01-23 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S002) | Carbon Medical Technologies, Inc. | 2001-01-23 |
| ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S037) | Boston Scientific | 2001-01-23 |
| PROMINENT CALC FEATURE MARKER (P970058/S009) | Hologic, Inc. | 2001-01-22 |
| PROCEED HEMOSTATIC SEALANT (P990009/S001) | Baxter Healthcare Corp | 2001-01-22 |
| EMDOGAIN (P930021/S004) | The Straumann Company | 2001-01-19 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S009) | Boston Scientific Corp | 2001-01-19 |
| CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM (P950022/S012) | ABBOTT MEDICAL | 2001-01-18 |
| CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM (P910023/S050) | ABBOTT MEDICAL | 2001-01-18 |
| LASER SHEATH (P960042/S006) | Spectranetics (Philips) | 2001-01-17 |
| PC-IOL (P970034/S007) | Aaren Scientific | 2001-01-17 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- ADULTS (P840024/S080) | Cochlear Americas | 2001-01-16 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S012) | Cochlear Americas | 2001-01-16 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S028) | Terumo Medical Corporation | 2001-01-16 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- CHILDREN (P890027/S049) | Cochlear Americas | 2001-01-16 |
| MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC) (P960058/S015) | Advanced Bionics | 2001-01-12 |
| LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S004) | Depuy Spine, Inc. | 2001-01-12 |
| MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT) (P940022/S016) | Advanced Bionics Corp. | 2001-01-12 |
| NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\ (P990025/S003) | Biosense Webster, Inc. | 2001-01-11 |
| RX CHASSIS I CORONARY DILATATION CATHETER (P810046/S203) | Advanced Cardiovascular Systems, Inc. | 2001-01-11 |
| (R) QUANTUM MONORAIL(TM) PTCA CATHETER (P860019/S167) | Scimed Life Systems, Inc. | 2001-01-11 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S006) | Medtronic Minimed | 2001-01-09 |
| VITATRON DIVA PLATFORM (P990001/S005) | Medtronic, Inc. | 2001-01-08 |
| MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554 (P850089/S045) | Medtronic Cardiac Rhythm Disease Management | 2001-01-08 |
| SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S002) | GE Healthcare | 2001-01-08 |
| D114S OTW BALLOON DILATATION CATHETER (P790017/S074) | Medtronic, Ireland | 2001-01-08 |
| TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES (P000023) | Nexus CMF, LLC | 2001-01-05 |
| STARR EDWARDS SILASTIC BALL VALVE (P870038/S004) | Edwards Lifesciences, LLC | 2001-01-05 |
| UVAR XTS(TM) PHOTOPHERESIS SYSTEM (P860003/S037) | Therakos Development Limited | 2001-01-05 |
| VIBRANT D SOUNDBRIDGE SYSTEM (P990052/S002) | Med-El Elektromedizinische Gerate GmbH | 2001-01-03 |
| COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT (P990030/S001) | Angiotech Medical Device Technologies | 2001-01-02 |