| BLAZER II CARDIAC ABLATION CATHETHER, STEEROCATH-A CARDIAC ABLATION CATHETER,STEEROCATH-T CARDIAC ABLATION CATHETER (P920047/S021) | Boston Scientific Corp | 2003-12-31 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S010) | Boston Scientific Corp | 2003-12-31 |
| CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM (P990054/S006) | Boston Scientific Corp | 2003-12-31 |
| IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA (P930027/S006) | Siemens Healthcare Diagnostics, Inc. | 2003-12-31 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P020025/S002) | Boston Scientific | 2003-12-31 |
| IMMULITE 2500 AFP, MODEL L5KAP (P010007/S002) | Siemens Healthcare Diagnostics, Inc. | 2003-12-31 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S003) | Siemens Healthcare Diagnostics | 2003-12-30 |
| MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II (P980016/S039) | Medtronic Cardiac Rhythm Disease Management | 2003-12-29 |
| 2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY (P890003/S073) | Medtronic, Inc. | 2003-12-29 |
| MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II (P010031/S011) | Medtronic Cardiac Rhythm Disease Management | 2003-12-29 |
| ACRYSOF IOL MODEL SN60WF (P930014/S013) | Alcon Laboratories, Inc. | 2003-12-24 |
| VENTAK PRIZM MODELS 1850 AND 1851 (P960040/S038) | Boston Scientific | 2003-12-24 |
| CONTAK CD 2 MODEL H115 (P010012/S019) | Boston Scientific Corp | 2003-12-24 |
| VENTAK MINI I, II,III (P910077/S043) | Boston Scientific | 2003-12-24 |
| QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM (P010049/S009) | Sub-Q, Inc. | 2003-12-23 |
| ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S039) | Abiomed Cardiovascular, Inc. | 2003-12-23 |
| VNS THERAPY SYSTEM (P970003/S052) | LivaNova USA, Inc. | 2003-12-23 |
| SILIKON 1000 (P950008/S006) | Alcon | 2003-12-22 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S009) | Gynecare, Inc. | 2003-12-22 |
| TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S008) | Boston Scientific Corp | 2003-12-22 |
| CONTAK CD/CD2, RENEWAL (P010012/S018) | Boston Scientific Corp | 2003-12-19 |
| MERIDIAN, DISCOVERY (P940031/S029) | Boston Scientific | 2003-12-19 |
| FINELINE II PACING LEADS (P960004/S023) | Boston Scientific | 2003-12-19 |
| VENTTAK AV/PRIZM/PRIZM2,VITALITY (P960040/S037) | Boston Scientific | 2003-12-19 |
| VENTAK MINI III,MINI IV (P910077/S042) | Boston Scientific | 2003-12-19 |
| ENPULSE INPLANTABLE PULSE GENERATOR (P980035/S030) | Medtronic, Inc. | 2003-12-18 |
| X-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM (P020035/S001) | St. Jude Medical, Inc. | 2003-12-18 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S022) | Guidant Corp. | 2003-12-18 |
| VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER (P960040/S034) | Boston Scientific | 2003-12-17 |
| LCS UNICOMPARTMENTAL KNEE SYSTEM (P910016/S013) | Depuy, Inc. | 2003-12-17 |
| VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910077/S040) | Boston Scientific | 2003-12-17 |
| CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S015) | Boston Scientific Corp | 2003-12-17 |
| PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T (P950037/S033) | Biotronik, Inc. | 2003-12-17 |
| ON-X PROSTHETIC HEART VALVE (P000037/S003) | On-X Life Technologies, Inc. | 2003-12-16 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S032) | Advanced Bionics | 2003-12-16 |
| MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM (P960009/S027) | Medtronic, Inc. | 2003-12-16 |
| TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S018) | Shire Regenerative Medicine | 2003-12-15 |
| SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P980040/S005) | Johnson & Johnson Surgical Vision, Inc. | 2003-12-15 |
| DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL REPLACEMENT (P000036/S003) | Shire Regenerative Medicine | 2003-12-15 |
| HEALON SODIUM HYALURONATE (P810031/S025) | Johnson & Johnson Surgical Vision, Inc. | 2003-12-12 |
| COSEAL SURGICAL SEALANT (P030039) | Baxter Bio Science | 2003-12-12 |
| RESTYLANE INJECTABLE GEL (P020023) | Q-Med AB | 2003-12-12 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S008) | Boston Scientific Corporation | 2003-12-11 |
| WALL STENT ILIAC ENDOPROSTHESIS (P940019/S016) | Boston Scientific Scimed, Inc. | 2003-12-11 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S018) | Boston Scientific Corp | 2003-12-11 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S013) | Boston Scientific Scimed, Inc. | 2003-12-10 |
| FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM (P970031/S013) | Medtronic, Inc. | 2003-12-08 |
| PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM (P000011/S009) | Abbott Vascular, Inc. | 2003-12-08 |
| CERASORB DENTAL (P800035/S011) | Curasan AG | 2003-12-08 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S007) | Hologic, Inc. | 2003-12-05 |
| BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S006) | Medtimo, Inc. | 2003-12-05 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S010) | Integra Lifesciences Corp. | 2003-12-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007) | Genzyme Corp. | 2003-12-04 |
| THORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S022) | Thoratec Corp | 2003-12-02 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S010) | Gynecare, Inc. | 2003-12-02 |
| EMDOGAIN GEL (P930021/S008) | The Straumann Company | 2003-12-02 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S004) | Medtronic Sofamor Danek USA, Inc. | 2003-12-01 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S007) | Closure Medical Corp. | 2003-12-01 |
| MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT (P790018/S045) | Medtronic Cardiac Surgery | 2003-11-28 |
| DIASORIN ETI-AB-COREK PLUS ASSAY (P990045/S005) | DiaSorin, Inc. | 2003-11-26 |
| ENTERYX PROCEDURE KIT (P020006/S001) | Boston Scientific Corp | 2003-11-26 |
| THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S026) | Thoratec Laboratories Corp. | 2003-11-26 |
| KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM (N980003) | Djo Surgical | 2003-11-26 |
| IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1) (P970058/S018) | Hologic, Inc. | 2003-11-26 |
| IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0) (P970058/S017) | Hologic, Inc. | 2003-11-25 |
| OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION) (P860047/S015) | Bausch & Lomb, Inc. | 2003-11-25 |
| CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM (P960043/S046) | Abbott Vascular, Inc. | 2003-11-25 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S020) | Boston Scientific Corp | 2003-11-25 |
| BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR (P860022/S055) | Bausch & Lomb | 2003-11-25 |
| PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM (P960043/S049) | Abbott Vascular, Inc. | 2003-11-25 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE (P960016/S012) | St Jude Medical | 2003-11-21 |
| LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S017) | Alcon Laboratories | 2003-11-21 |
| BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942) (P830060/S052) | Boston Scientific | 2003-11-21 |
| HEX WRENCH(MODEL 6501) (P930035/S011) | Boston Scientific | 2003-11-21 |
| VNS THERAPY SYSTEM (P970003/S049) | LivaNova USA, Inc. | 2003-11-20 |
| THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S023) | Thoratec Laboratories Corp. | 2003-11-20 |
| GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR (P990026/S018) | Animas Corp. | 2003-11-20 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S039) | Best Vascular, Inc. | 2003-11-18 |
| LCS TOTAL KNEE SYSTEM (P830055/S086) | Depuy, Inc. | 2003-11-18 |
| LCS TOTAL KNEE SYSTEM (P830055/S087) | Depuy, Inc. | 2003-11-18 |
| MEDTRONIC MODEL 8749 INTRATHECAL CATHETER (P860004/S057) | Medtronic, Inc. | 2003-11-18 |
| KENTROX RV-S/KENTROX SL-S ICD LEADS (P980023/S012) | Biotronik, Inc. | 2003-11-18 |
| MEDTRONIC. KAPPA 400 SERIES PACEMAKERS (P970012/S015) | Medtronic, Inc. | 2003-11-17 |
| MEDTRONIC. GEM DR MODEL 7271 D (P980016/S036) | Medtronic Cardiac Rhythm Disease Management | 2003-11-17 |
| INTERSTIM MODEL 3023 AND TRANSCEND MODEL 3726 IMPLANTABLE NEUROSTIMULATORS (P970004/S026) | Medtronic Neuromodulation | 2003-11-17 |
| MEDTRONIC KAPPA 700/600 SERIES (P980035/S031) | Medtronic, Inc. | 2003-11-17 |
| ITREL (R) TOTALLY IMPLANTABLE (P840001/S071) | Medtronic Neuromodulation | 2003-11-17 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S028) | Medtronic, Inc. | 2003-11-17 |
| OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S005) | Beam-Med, Ltd. | 2003-11-17 |
| INSYNC MODEL 7272 (P010031/S009) | Medtronic Cardiac Rhythm Disease Management | 2003-11-17 |
| MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM (P010015/S011) | Medtronic, Inc. | 2003-11-17 |
| SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S019) | ETHICON, Inc. | 2003-11-17 |
| SYNERGYST PULSE II GENERATOR (P890003/S072) | Medtronic, Inc. | 2003-11-17 |
| JEWEL AF 7250 (P980050/S014) | Medtronic, Inc. | 2003-11-17 |
| UROLUME ENDOURETHRAL PROSTHESIS (P920023/S017) | Boston Scientific Corp | 2003-11-14 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC (P860057/S018) | Edwards Lifesciences, LLC | 2003-11-14 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P030002) | Bausch & Lomb, Inc. | 2003-11-14 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL (P990023/S002) | Alcon Laboratories | 2003-11-14 |
| BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM) (P000009/S009) | Biotronik, Inc. | 2003-11-13 |
| AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM (P020024/S001) | ABBOTT MEDICAL | 2003-11-13 |