| SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE (P960025/S011) | Depuy Spine, Inc. | 2004-03-05 |
| PROVISC OPHTHALMIC VICOSURGICAL DEVICE (P890047/S016) | Alcon Research, Ltd. | 2004-03-05 |
| DUOVISC VISCOELASTIC SYSTEM (P840064/S025) | Alcon Laboratories | 2004-03-05 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S021) | Guidant Corp. | 2004-03-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR (P030026) | Ortho-Clinical Diagnostics, Inc. | 2004-03-04 |
| BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN (P900043/S042) | Cordis Corp. | 2004-03-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR (P030024) | Ortho-Clinical Diagnostics | 2004-03-04 |
| SOFTLENS66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS (P960022/S004) | Bausch & Lomb, Inc. | 2004-03-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025) | Boston Scientific Corp | 2004-03-04 |
| ABBOTT AXSYM/TOTAL PSA (P910007/S006) | Abbott Laboratories | 2004-03-03 |
| VNS THERAPY SYSTEM (P970003/S054) | LivaNova USA, Inc. | 2004-03-03 |
| VNS THERAPY SYSTEM (P970003/S053) | LivaNova USA, Inc. | 2004-03-03 |
| RESTYLANE INJECTABLE GEL (P020023/S003) | Q-Med AB | 2004-03-03 |
| CONTAK RENEWAL TR, MODELS H120, H125 (P030005/S001) | Guidant Corp. | 2004-03-03 |
| SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S004) | Hologic, Inc. | 2004-03-02 |
| ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187 (P910073/S043) | Boston Scientific | 2004-03-02 |
| DEFLUX INJECTABLE GEL (P000029/S006) | Palette Life Sciences | 2004-03-01 |
| FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY (P990080/S004) | Johnson & Johnson Surgical Vision, Inc. | 2004-03-01 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S010) | Medtronic Ats Medical, Inc. | 2004-02-27 |
| GLUCOWATCH G2 BIOGRAPHER (P990026/S021) | Animas Corp. | 2004-02-25 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S005) | W. L. Gore & Associates, Inc. | 2004-02-25 |
| LCS TOTAL KNEE SYSTEM (P830055/S085) | Depuy, Inc. | 2004-02-25 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S013) | Med-El Corp. | 2004-02-25 |
| HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S004) | Axora Medical, Inc. | 2004-02-24 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR (P990071/S004) | Biosense Webster, Inc. | 2004-02-24 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S001) | Boston Scientific | 2004-02-23 |
| MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE (P980035/S032) | Medtronic, Inc. | 2004-02-20 |
| DIASORIN ETI-AB-EBK PLUS ASSAY (P990041/S004) | DiaSorin, Inc. | 2004-02-20 |
| DIASORIN ETI-AB-HAVK PLUS ASSAY (P890019/S009) | Diasorin | 2004-02-20 |
| SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S016) | GE Healthcare | 2004-02-19 |
| PROLIEVE THERMODILATATION SYSTEM (P030006) | Medifocus, Inc. | 2004-02-19 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S033) | Advanced Bionics | 2004-02-18 |
| MEDTRONIC SIGMA MODELS SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 AND SVDD303 (P980035/S033) | Medtronic, Inc. | 2004-02-17 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S035) | Best Vascular, Inc. | 2004-02-17 |
| INTRACOIL PERIPHERAL STENT (P000033/S001) | Medtronic Vascular, Inc. | 2004-02-13 |
| SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3) (P950029/S019) | MicroPort CRM USA, Inc. | 2004-02-13 |
| RESTYLANE INJECTABLE GEL (P020023/S002) | Q-Med AB | 2004-02-13 |
| DIASORIN ETI-EBK PLUS ASSAY (P990043/S005) | DiaSorin, Inc. | 2004-02-12 |
| EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513 (P010012/S022) | Boston Scientific Corp | 2004-02-12 |
| DAKOCYTOMATION EGFR PHARMDX (P030044) | Agilent Technologies, Inc. | 2004-02-12 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S002) | Cook, Inc. | 2004-02-12 |
| PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM (P960043/S048) | Abbott Vascular, Inc. | 2004-02-11 |
| PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S005) | Bausch & Lomb, Inc. | 2004-02-11 |
| SELUTE (P950001/S010) | Boston Scientific | 2004-02-10 |
| MERIDIAN DISCOVERY (P940031/S030) | Boston Scientific | 2004-02-10 |
| QUANTIFERON - TB (P010033/S007) | Qiagen | 2004-02-10 |
| FINELINE/ THINLINE (P960004/S024) | Boston Scientific | 2004-02-10 |
| SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND (P960006/S009) | Boston Scientific | 2004-02-10 |
| ENDOTAK/ ENDURANCE/ RELIANCE (P910073/S044) | Boston Scientific | 2004-02-10 |
| RES-Q (P940008/S018) | Boston Scientific | 2004-02-10 |
| CONTAK CD/CD2/RENEWAL/EASYTRAK (P010012/S021) | Boston Scientific Corp | 2004-02-10 |
| GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S015) | Gen-Probe, Inc. | 2004-02-10 |
| VENTAK (P830060/S053) | Boston Scientific | 2004-02-10 |
| VENTAK AV/ PRIZM/PRIZM2/ VITALITY (P960040/S040) | Boston Scientific | 2004-02-10 |
| VENTAK PRX/ MINI III/ MINI IV (P910077/S044) | Boston Scientific | 2004-02-10 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S012) | Boston Scientific Corp | 2004-02-09 |
| CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM (P990054/S005) | Boston Scientific Corp | 2004-02-09 |
| LADAR VISION 4000 EXCIMER LASER SYSTEM (P970043/S016) | Alcon Laboratories | 2004-02-09 |
| MEDTRONIC CAPSUREFIX NOVUS MODEL 4076 LEAD (P930039/S017) | Medtronic, Inc. | 2004-02-09 |
| THINPREP 2000 SYSTEM (P950039/S011) | Hologic, Inc. | 2004-02-09 |
| CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S017) | Boston Scientific Corp | 2004-02-06 |
| MEDTRONIC INSYNC 11 PROTECT MODEL 7295 WITH THE MODEL 9992 APPLICATION SOFTWARE (P010031/S008) | Medtronic Cardiac Rhythm Disease Management | 2004-02-06 |
| VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910077/S041) | Boston Scientific | 2004-02-06 |
| VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S036) | Boston Scientific | 2004-02-06 |
| NOVASURE IMPEDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S006) | Hologic, Inc. | 2004-02-05 |
| MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS (P930029/S021) | Medtronic, Inc. | 2004-02-05 |
| ABBOTT IMX FREE PSA (P980007/S003) | Abbott Laboratories | 2004-02-05 |
| AXSYM FREE PSA (P980007) | Abbott Laboratories | 2004-02-05 |
| CHILLI COOLED ABLATION CATHETERS (P980003/S009) | Boston Scientific Corp | 2004-02-05 |
| ABBOTT ARCHITECT FREE PSA (P980007/S002) | Abbott Laboratories | 2004-02-05 |
| ABBOTT AXSYM ANTIBODY TO HCV (P970027) | Abbott Laboratories | 2004-02-05 |
| NEEDLE ZAP (P010065/S002) | E Med Future | 2004-02-05 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019) | Anika Therapeutics, Inc. | 2004-02-04 |
| ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (N18033/S039) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2004-02-04 |
| RESTYLANE INJECTABLE GEL (P020023/S001) | Q-Med AB | 2004-02-04 |
| ABBOTT ARCHITECT TOTAL PSA (P910007/S007) | Abbott Laboratories | 2004-02-02 |
| ABBOTT ARCHITECHT AFP (P820060/S013) | Abbott Laboratories | 2004-02-02 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S001) | Cook, Inc. | 2004-02-02 |
| ABBOTT AXSYM AFP (P820060/S019) | Abbott Laboratories | 2004-02-02 |
| ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER (P820060/S016) | Abbott Laboratories | 2004-02-02 |
| ABBOTT AXSYM HAVAB 2.0 (P780012/S009) | Abbott Laboratories | 2004-02-02 |
| ABBOTT IMX TOTAL PSA (P910007/S009) | Abbott Laboratories | 2004-02-02 |
| ABBOTT AXSYM TOTAL PSA (P910007/S005) | Abbott Laboratories | 2004-02-02 |
| ABBOTT AXSYM HAVAB-M 2.0 (P790019/S011) | Abbott Laboratories | 2004-02-02 |
| VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR (P880086/S098) | ABBOTT MEDICAL | 2004-01-30 |
| ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S015) | Medtronic Vascular | 2004-01-30 |
| VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR (P830045/S090) | St. Jude Medical, Inc. | 2004-01-30 |
| VISTA LORDOTIC INTERBODY FUSION CAGE (P950002/S013) | Zimmer Spine, Inc. | 2004-01-29 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S027) | Medtronic Neuromodulation | 2004-01-28 |
| PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000 (P860057/S022) | Edwards Lifesciences, LLC | 2004-01-26 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005) | Guidant Corp. | 2004-01-26 |
| MOSAIC PORCINE BIOPROSTHESIS MODELS 305, 310 (P990064/S009) | Medtronic, Inc. | 2004-01-23 |
| HANCOCK II BIOPROTHESIS MODELS T505, T510 (P980043/S004) | Medtronic, Inc. | 2004-01-23 |
| APILGRAF (P950032/S037) | Organogenesis, Inc. | 2004-01-23 |
| TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM (P000035/S003) | Nexus CMF, LLC | 2004-01-22 |
| TMJ FOSSA EMINENCE PROSTHESIS SYSTEM (P000023/S003) | Nexus CMF, LLC | 2004-01-22 |
| BSD-500 HYPERTHERMIA SYSTEM (P820088/S017) | Pyrexar Medical, Inc. | 2004-01-20 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S009) | ABBOTT MEDICAL | 2004-01-20 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S004) | Beckman Coulter, Inc. | 2004-01-20 |
| SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS (P990075/S014) | Mentor Worldwide, LLC | 2004-01-16 |