| MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 5033 (P850089/S051) | Medtronic Cardiac Rhythm Disease Management | 2003-05-09 |
| MEDTRONIC MODEL 4193 ATTAIN OTW LEAD (P010015/S010) | Medtronic, Inc. | 2003-05-09 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S019) | Edwards Lifesciences, LLC | 2003-05-09 |
| MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 4968 (P950024/S006) | Medtronic, Inc. | 2003-05-09 |
| OCUCOAT(2%HYDROXYPROPYLMETHLCELLULOSE SOLUTION) (P860047/S013) | Bausch & Lomb, Inc. | 2003-05-08 |
| RESPONSE CV CATHETER SYSTEM (P020052) | St Jude Medical | 2003-05-07 |
| THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S006) | Gynecare, Inc. | 2003-05-07 |
| DIASORIN ETI-CORE-IGMK PLUS (P990044/S004) | DiaSorin, Inc. | 2003-05-07 |
| DIASORIN ETI-HA-IGMK PLUS (P890014/S005) | DiaSorin, Inc. | 2003-05-06 |
| COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED) (P010022/S003) | Angiotech Medical Device Technologies | 2003-05-06 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE AND FIBRILLAR FORM (P810006/S021) | Integra LifeSciences Corporation | 2003-05-05 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE & FIBRILLAR FORM (P850010/S018) | Integra LifeSciences Corporation | 2003-05-05 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S009) | Integra Lifesciences Corp. | 2003-05-05 |
| EXCLUDER BIFURCATED ENDOPROSTHEIS (P020004/S002) | W. L. Gore & Associates, Inc. | 2003-05-05 |
| CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S023) | Spectranetics Corp. | 2003-05-02 |
| STORMER Z BALLOON DILATATION/NC STORMER Z BALLOON DILATATION CATHETER (P790017/S080) | Medtronic, Ireland | 2003-05-02 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S036) | Terumo Medical Corporation | 2003-05-02 |
| S7 AND S660 ZIPPER MX CORONARY STENT SYSTEMS (P970035/S045) | Medtronic, Ireland | 2003-05-02 |
| PREPSTAIN (TM) SYSTEM (P970018/S006) | Bd Diagnostic Systems | 2003-05-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S001) | Ortho-Clinical Diagnostics, Inc. | 2003-04-30 |
| CUTTING BALLOON ULTRA (P950020/S007) | Boston Scientific Corp | 2003-04-30 |
| ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S037) | Abiomed Cardiovascular, Inc. | 2003-04-28 |
| THORATEC VAD SYSTEM; SEALED ARTERIAL CANNULAE, 14 MM AND 18 MM GRAFT (P870072/S025) | Thoratec Laboratories Corp. | 2003-04-25 |
| SEPRAFILM ADHESION BARRIER AND SEPRAFILM PROCEDURE PACK (P950034/S024) | Baxter Healthcare Corporation | 2003-04-25 |
| NMP22 BLADDERCHEK TEST KIT (P940035/S003) | Abbott Diagnostics Scarborough, Inc. | 2003-04-25 |
| INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM (P010031/S006) | Medtronic Cardiac Rhythm Disease Management | 2003-04-24 |
| SUNLIGHT OMNISENSE BONE SONOMETER (P990035/S006) | Beam-Med, Ltd. | 2003-04-24 |
| QUICKSEAL II ARTERIAL CLOSURE SYSTEM (P010049/S006) | Sub-Q, Inc. | 2003-04-24 |
| SIR-SPHERES (P990065/S001) | Sirtex Medical, Inc. | 2003-04-24 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026) | Cordis Corp. | 2003-04-24 |
| EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P830045/S084) | St. Jude Medical, Inc. | 2003-04-23 |
| EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P880086/S092) | ABBOTT MEDICAL | 2003-04-23 |
| EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S065) | ABBOTT MEDICAL | 2003-04-23 |
| VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P960040/S025) | Boston Scientific | 2003-04-23 |
| SOLOX VDD PACING LEAD (P950037/S024) | Biotronik, Inc. | 2003-04-23 |
| NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS (P990025/S006) | Biosense Webster, Inc. | 2003-04-22 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S003) | W. L. Gore & Associates, Inc. | 2003-04-22 |
| EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM (P900009/S017) | Bioventus, LLC | 2003-04-22 |
| NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS (P950005/S016) | Biosense Webster, Inc. | 2003-04-22 |
| ENTERYX PROCEDURE KIT (P020006) | Boston Scientific Corp | 2003-04-22 |
| GELFOAM ABORBABLE GELATIN SPONGE (N18286/S014) | Pfizer, Inc. | 2003-04-21 |
| PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS,MODEL 6900P,MITRAL (P860057/S021) | Edwards Lifesciences, LLC | 2003-04-18 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045) | Medtronic Cryocath, LP | 2003-04-17 |
| S670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S039) | Medtronic, Ireland | 2003-04-17 |
| OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION) (P860047/S012) | Bausch & Lomb, Inc. | 2003-04-16 |
| AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE (P980035/S027) | Medtronic, Inc. | 2003-04-16 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S003) | Bayer Pharma AG | 2003-04-11 |
| ISOFLEX S PERMANENT PACING LEAD MODELS (P960030/S010) | ABBOTT MEDICAL | 2003-04-10 |
| GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S017) | Guidant Corp. | 2003-04-09 |
| PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM (P960043/S044) | Abbott Vascular, Inc. | 2003-04-04 |
| CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S001) | Ceramtec GmbH | 2003-04-04 |
| THORETEC HEARTMATE XVE LVAS (P920014/S017) | Thoratec Corp | 2003-04-04 |
| DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE (P010040/S002) | Redhawk Medical Products & Services, LLC | 2003-04-04 |
| SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES (P960022/S003) | Bausch & Lomb, Inc. | 2003-04-04 |
| VASOSEAL DEVICES (P920004/S019) | St. Jude Medical, Inc. | 2003-04-03 |
| SPRINT/SPRINT QUATTRO (P920015/S027) | Medtronic, Inc. | 2003-04-03 |
| SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM (P010039/S002) | Siemens Medical Solutions USA, Inc. | 2003-04-03 |
| CAPSURE FIX (P980016/S034) | Medtronic Cardiac Rhythm Disease Management | 2003-04-03 |
| CAPSURE SP NOVUS/Z NOVUS (P850089/S052) | Medtronic Cardiac Rhythm Disease Management | 2003-04-03 |
| CAPSURE FIX/NOVUS (P930039/S015) | Medtronic, Inc. | 2003-04-03 |
| CAPSURE SP/SENSE/SP NOVUS (P830061/S036) | Medtronic Cardiac Rhythm Disease Management | 2003-04-03 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS) (P840024/S085) | Cochlear Americas | 2003-04-02 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN) (P890027/S054) | Cochlear Americas | 2003-04-02 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (P000015/S004) | Cochlear Americas | 2003-04-02 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S024) | Cochlear Americas | 2003-04-02 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S024) | Medtronic Neuromodulation | 2003-04-01 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S006) | Boston Scientific Corporation | 2003-04-01 |
| UROLOGIX TARGIS SYSTEM (P970008/S021) | Urologix, LLC | 2003-04-01 |
| REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER (P860019/S194) | Scimed Life Systems, Inc. | 2003-04-01 |
| THORATEC HEARTMATE LVAS (P920014/S018) | Thoratec Corp | 2003-04-01 |
| DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST (P890064/S009) | Qiagen Gaithersburg, Inc. | 2003-03-31 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S009) | St Jude Medical | 2003-03-28 |
| EMDOGAIN GEL (P930021/S006) | The Straumann Company | 2003-03-28 |
| BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA) (P020022) | Siemens Healthcare Diagnostics, Inc. | 2003-03-28 |
| FEMCAP BARRIER CONTRACEPTIVE (P020041) | Femcap Incorporated | 2003-03-28 |
| THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC (P950039/S010) | Hologic, Inc. | 2003-03-27 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S007) | Gynecare, Inc. | 2003-03-27 |
| MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION 3 (P010031/S003) | Medtronic Cardiac Rhythm Disease Management | 2003-03-27 |
| VENTAK PRIZM AVT AICD SYSTEM (P960040/S028) | Boston Scientific | 2003-03-27 |
| INSYNC III MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE (P010015/S009) | Medtronic, Inc. | 2003-03-27 |
| VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812 (P960040/S029) | Boston Scientific | 2003-03-26 |
| MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE (P980035/S013) | Medtronic, Inc. | 2003-03-26 |
| MENTOR SALINE-FILLED BREAST IMPLANT (P990075/S011) | Mentor Worldwide, LLC | 2003-03-26 |
| EASYTRAK 3 PACING LEAD (P010012/S009) | Boston Scientific Corp | 2003-03-25 |
| RIATA DEFIBRILLATION LEAD SYSTEM MODEL 1572 AND 1582 (P950022/S016) | ABBOTT MEDICAL | 2003-03-25 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS (P000025/S008) | Med-El Corp. | 2003-03-25 |
| SEPRAFILM ADHESION BARRIER & SEPRAFILM PROCEDURE PACK (P950034/S023) | Baxter Healthcare Corporation | 2003-03-25 |
| THORATEC HEARTMATE STROKE VOLUME LIMITER (P920014/S020) | Thoratec Corp | 2003-03-21 |
| VIGOR DR/SR AND DISCOVERY MERIDIAN AR (P940031/S027) | Boston Scientific | 2003-03-21 |
| VENTAK PRX AND MINI ICDS (P910077/S039) | Boston Scientific | 2003-03-21 |
| VENTAK AV AND VENTAK PRIZM DR/VR AICDS (P960040/S030) | Boston Scientific | 2003-03-21 |
| CONTAK CD (P010012/S007) | Boston Scientific Corp | 2003-03-21 |
| IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A (P910023/S066) | ABBOTT MEDICAL | 2003-03-20 |
| IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A (P880086/S093) | ABBOTT MEDICAL | 2003-03-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK/ CALIBRATOR (P000044/S003) | Ortho-Clinical Diagnostics, Inc. | 2003-03-20 |
| GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S018) | Guidant Corp. | 2003-03-20 |
| IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A (P830045/S085) | St. Jude Medical, Inc. | 2003-03-20 |
| PERFLUORON (P950018/S009) | Alcon Laboratories | 2003-03-20 |
| NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS (P010019/S002) | Alcon Laboratories, Inc. | 2003-03-19 |
| TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S005) | Boston Scientific Corp | 2003-03-19 |