| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB (P800002/S013) | C.R. Bard, Inc. | 2003-07-11 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR AND AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S020) | Davol Inc., Sub. C. R. Bard, Inc. | 2003-07-11 |
| DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210 (P990037/S020) | Vascular Solutions, Inc. | 2003-07-11 |
| CONTAK CD 2 CRT-D SYSTEMS (P010012/S011) | Boston Scientific Corp | 2003-07-10 |
| FLOSEAL NT HEMOSTATIC MATRIX (P990009/S014) | Baxter Healthcare Corp | 2003-07-10 |
| VITALITY DS ICD SYSTEMS (P960040/S031) | Boston Scientific | 2003-07-10 |
| SYNVISC (P940015/S008) | Sanofi Genzyme Corp. | 2003-07-09 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S006) | Ortho-Clinical Diagnostics, Inc. | 2003-07-09 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S077) | Boston Scientific Corp | 2003-07-08 |
| BAK VISTA INTERBODY FUSION DEVICE (P950002/S011) | Zimmer Spine, Inc. | 2003-07-08 |
| CERAMIC TRANSCEND HIP ARTICULATION (P030027) | Microport Orthopedics, Inc. | 2003-07-07 |
| HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K) (P960058/S030) | Advanced Bionics | 2003-07-07 |
| UROLOGIX TARGIS SYSTEM (P970008/S023) | Urologix, LLC | 2003-07-07 |
| FLOSEAL MATRIX HEMOSTATIC SEALANT (P990009/S015) | Baxter Healthcare Corp | 2003-07-03 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S009) | Nmt Medical, Inc. | 2003-07-03 |
| AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S003) | Medtronic Sofamor Danek USA, Inc. | 2003-07-02 |
| THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS (P960004/S022) | Boston Scientific | 2003-07-02 |
| BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY (P900043/S044) | Cordis Corp. | 2003-07-02 |
| MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2) (P010012/S012) | Boston Scientific Corp | 2003-07-02 |
| ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS (P980049/S009) | MicroPort CRM USA, Inc. | 2003-07-02 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S002) | Bayer Pharma AG | 2003-07-01 |
| ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS (P950022/S017) | ABBOTT MEDICAL | 2003-07-01 |
| ETI-AB-AUK PLUS (P990042/S006) | DiaSorin, Inc. | 2003-06-30 |
| RAPIDSCREEN RS-2000D (P000041/S001) | Riverain Medical Group | 2003-06-30 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S016) | Guidant Corp. | 2003-06-27 |
| ETI-CORE-IGMK PLUS (P990044/S003) | DiaSorin, Inc. | 2003-06-26 |
| ETI-AB-COREK PLUS (P990045/S004) | DiaSorin, Inc. | 2003-06-26 |
| ETI-EBK PLUS (P990043/S004) | DiaSorin, Inc. | 2003-06-26 |
| BETA-CATH 3.5F SYSTEM - 60 MM (P000018/S028) | Best Vascular, Inc. | 2003-06-25 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S034) | Best Vascular, Inc. | 2003-06-25 |
| VENTAK PRIZM AVT (P960040/S033) | Boston Scientific | 2003-06-25 |
| TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S006) | Boston Scientific Corp | 2003-06-24 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S003) | Medtronic Sofamor Danek USA, Inc. | 2003-06-24 |
| ACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL) (P930014/S009) | Alcon Laboratories, Inc. | 2003-06-24 |
| INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE (P970015/S021) | Sofamor Danek | 2003-06-24 |
| ENDOTAK RELIANCE STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S042) | Boston Scientific | 2003-06-24 |
| DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S012) | Qiagen Gaithersburg, Inc. | 2003-06-20 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S019) | Boston Scientific Corp | 2003-06-19 |
| THE ANEURX STENT SYSTEM (P990020/S012) | Medtronic Vascular | 2003-06-19 |
| QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001) | Quidel Corp. | 2003-06-19 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S017) | Animas Corp. | 2003-06-17 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S001) | Boston Scientific Corp | 2003-06-16 |
| EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD (P010012/S010) | Boston Scientific Corp | 2003-06-13 |
| DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT (P990037/S019) | Vascular Solutions, Inc. | 2003-06-13 |
| TENDRIL SDX PERMANENT PACEMAKER LEADS, MODELS 1688T/TC (P960013/S013) | ABBOTT MEDICAL | 2003-06-13 |
| CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE (P010012/S008) | Boston Scientific Corp | 2003-06-13 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S006) | Closure Medical Corp. | 2003-06-13 |
| SLEEP SENTRY (P810044/S004) | Diabetes Sentry Products, LLC | 2003-06-12 |
| DAKOCYTOMATION HERCEP TEST (P980018/S002) | Agilent Technologies Singapore (International) Pte , Ltd. | 2003-06-11 |
| ETI-AB-EBK PLUS (P990041/S003) | DiaSorin, Inc. | 2003-06-11 |
| IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS. (P010050/S003) | Siemens Healthcare Diagnostics Products, Ltd. | 2003-06-11 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S033) | Best Vascular, Inc. | 2003-06-11 |
| FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P020037) | Abbott Vascular, Inc. | 2003-06-11 |
| LCS TOTAL KNEE SYSTEM (P830055/S084) | Depuy, Inc. | 2003-06-10 |
| FINISHING WIRE UNIVERSAL (P010012/S013) | Boston Scientific Corp | 2003-06-09 |
| VIEWPOINT CK SYSTEM (P010018/S002) | Refractec, Inc. | 2003-06-09 |
| THINPREP (R) IMAGING SYSTEM (P020002) | Hologic, Inc. | 2003-06-06 |
| CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES (P960058/S031) | Advanced Bionics | 2003-06-06 |
| OCUCOAT (P860047/S014) | Bausch & Lomb, Inc. | 2003-06-06 |
| MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM (P980035/S029) | Medtronic, Inc. | 2003-06-06 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS (P000025/S007) | Med-El Corp. | 2003-06-05 |
| CUTTING BALLOON ULTRA 2 (P950020/S008) | Boston Scientific Corp | 2003-06-04 |
| FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD (P960006/S008) | Boston Scientific | 2003-05-30 |
| PROSORBA COLUMN (P850020/S018) | Fresenius Hemocare, Inc. | 2003-05-30 |
| INTACS PRESCRIPTION INSERTS (P980031/S005) | Addition Technology | 2003-05-30 |
| TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE (P000009/S007) | Biotronik, Inc. | 2003-05-29 |
| SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK (P950034/S025) | Baxter Healthcare Corporation | 2003-05-28 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S005) | Carbon Medical Technologies, Inc. | 2003-05-28 |
| DUETT PRO SEALING DEVICE, DIAGNOSTIC DUETT PRO SEALING DEVICE AND D-STAT FLOWABLE HEMOSTAT (P990037/S018) | Vascular Solutions, Inc. | 2003-05-27 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S005) | Hologic, Inc. | 2003-05-27 |
| THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S013) | Medtronic Vascular | 2003-05-23 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018) | Cook, Inc. | 2003-05-23 |
| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S024) | Alcon Laboratories | 2003-05-23 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S015) | Alcon Research, Ltd. | 2003-05-23 |
| BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR (P850022/S014) | Ahp Eos Buyer, Inc. | 2003-05-23 |
| STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM (P930016/S016) | Amo Manufacturing USA, LLC | 2003-05-23 |
| STAARVISC II, SHELLGEL AND COEASE (P000046/S008) | Anika Therapeutics, Inc. | 2003-05-22 |
| EMDOGAIN GEL (P930021/S007) | The Straumann Company | 2003-05-20 |
| MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS (P990001/S012) | Medtronic, Inc. | 2003-05-20 |
| DUETT PRO SEALING DEVICE (MODEL 1010) AND DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210) (P990037/S015) | Vascular Solutions, Inc. | 2003-05-20 |
| PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER M (P960043/S045) | Abbott Vascular, Inc. | 2003-05-16 |
| COLLACOTE, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S008) | Integra Lifesciences Corp. | 2003-05-16 |
| MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM (P020007/S001) | Medtronic Vascular | 2003-05-15 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S021) | Thoratec Laboratories Corp. | 2003-05-14 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024) | ABBOTT MEDICAL | 2003-05-14 |
| CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980023/S014) | Biotronik, Inc. | 2003-05-14 |
| AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS (P000039/S005) | ABBOTT MEDICAL | 2003-05-13 |
| QUANTIFERON-TB KIT (P010033/S005) | Qiagen | 2003-05-12 |
| IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC (P910023/S067) | ABBOTT MEDICAL | 2003-05-09 |
| MDX SILICONE TUBING (P930039/S014) | Medtronic, Inc. | 2003-05-09 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S003) | Edwards Lifesciences, LLC | 2003-05-09 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S013) | Edwards Lifesciences, LLC | 2003-05-09 |
| ITREL, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS (P840001/S068) | Medtronic Neuromodulation | 2003-05-09 |
| IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC (P830045/S086) | St. Jude Medical, Inc. | 2003-05-09 |
| ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS (P990055/S006) | Siemens Healthcare Diagnostics | 2003-05-09 |
| ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS (P840001/S067) | Medtronic Neuromodulation | 2003-05-09 |
| CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS (P010041/S002) | Edwards Lifesciences, LLC | 2003-05-09 |
| MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON... (P830061/S035) | Medtronic Cardiac Rhythm Disease Management | 2003-05-09 |
| IDENTITY ADX XL DC,& SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC (P880086/S094) | ABBOTT MEDICAL | 2003-05-09 |
| MEDTRONIC MODEL CAPSUREFIX 6940 (P980016/S032) | Medtronic Cardiac Rhythm Disease Management | 2003-05-09 |