| ACTIVA TREMOR CONTROL THERAPY SYSTEM (P960009/S016) | Medtronic, Inc. | 2001-08-06 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S004) | Animas Corp. | 2001-08-03 |
| MODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS (P840001/S052) | Medtronic Neuromodulation | 2001-08-03 |
| VASOSEAL ES DEVICE (P920004/S013) | St. Jude Medical, Inc. | 2001-08-03 |
| NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S012) | Best Vascular, Inc. | 2001-08-01 |
| SYNCHROMED INFUSION SYSTEM (P860004/S047) | Medtronic, Inc. | 2001-08-01 |
| NATURAL-KNEE AND NATURAL-KNEE II (P940002/S005) | Sulzermedica | 2001-08-01 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S001) | Cochlear Americas | 2001-08-01 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S017) | Cochlear Americas | 2001-08-01 |
| DIMENSION PSA FLEX REAGENT CARTRIDGE (P000021/S001) | Siemens Healthcare Diagnostics | 2001-07-31 |
| MEDTRONIC ITREL(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS (P840001/S051) | Medtronic Neuromodulation | 2001-07-31 |
| BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER (P880065/S006) | Boston Scientific Corp | 2001-07-30 |
| ETAFILCON HYDROPHILIC CONTACT LENSES (N18033/S036) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2001-07-30 |
| BOSTON SCINTIFIC SCIMED PTCA CATHETER (P880027/S060) | Boston Scientific | 2001-07-30 |
| SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER (P990035/S002) | Beam-Med, Ltd. | 2001-07-27 |
| CORDIS CHECKMATE(TM) SYSTEM (P990036/S002) | Cordis Corp. | 2001-07-27 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE:SELF-TIGHTENING SLIPKNOT(STS) (P930038/S029) | Terumo Medical Corporation | 2001-07-26 |
| OMNICARBON CARDIAC VALVE PROSTHESIS (P830039/S007) | Medical Cv, Inc. | 2001-07-26 |
| ITREL(R) 3 SYSTEM (P840001/S050) | Medtronic Neuromodulation | 2001-07-26 |
| HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT (P960047/S003) | Howmedica Osteonics Corp. | 2001-07-25 |
| FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED) (P850079/S038) | CooperVision, Inc. | 2001-07-25 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS (P840024/S081) | Cochlear Americas | 2001-07-24 |
| VIBRANT SOUNDBRIDGE SYSTEM (P990052/S004) | Med-El Elektromedizinische Gerate GmbH | 2001-07-24 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN) (P890027/S050) | Cochlear Americas | 2001-07-24 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN (P970051/S016) | Cochlear Americas | 2001-07-24 |
| STARR COLLAMER (TM) UV ABSORBING PC IOL (P990013/S003) | Starr Surgical Co. | 2001-07-20 |
| FUSION MATRIX-DRY (P990009/S008) | Baxter Healthcare Corp | 2001-07-20 |
| DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE (P970015/S019) | Sofamor Danek | 2001-07-19 |
| PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER) (P910023/S053) | ABBOTT MEDICAL | 2001-07-18 |
| UBIS 5000 BONE SONOMETER (P000055) | Diagnostic Medical Systems | 2001-07-17 |
| APLIGRAF/GRAFTSKIN (P950032/S024) | Organogenesis, Inc. | 2001-07-16 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS (P900056/S065) | Boston Scientific Corp | 2001-07-16 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S002) | Genzyme Corp. | 2001-07-16 |
| BETA-CATH(TM) SYSTEM (P000018/S014) | Best Vascular, Inc. | 2001-07-13 |
| STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20 (P000026) | Starr Surgical Co. | 2001-07-12 |
| ACTIVA TREMOR CONTROL SYSTEM (P960009/S018) | Medtronic, Inc. | 2001-07-12 |
| BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S004) | Biotronik, Inc. | 2001-07-12 |
| RAPIDSCREEN RS-2000 (P000041) | Riverain Medical Group | 2001-07-12 |
| INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE (P830045/S076) | St. Jude Medical, Inc. | 2001-07-11 |
| INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A (P880086/S083) | ABBOTT MEDICAL | 2001-07-11 |
| AVITENE ULTRA FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE (N17600/S017) | Davol Inc., Sub. C. R. Bard, Inc. | 2001-07-11 |
| MODEL 6943 SPRINT(R) LEAD (P980050/S005) | Medtronic, Inc. | 2001-07-11 |
| FLOSEAL (R) MATRIX HEMOSTATIC SEALANT AND PROCEED (TM) HEMOSTATIC SEALANT (P990009/S003) | Baxter Healthcare Corp | 2001-07-10 |
| HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM (P000040/S001) | Axora Medical, Inc. | 2001-07-10 |
| LCS TOTAL KNEE SYSTEM (P830055/S079) | Depuy, Inc. | 2001-07-06 |
| DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE (P000021) | Siemens Healthcare Diagnostics | 2001-07-05 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S020) | Integra LifeSciences Corporation | 2001-07-05 |
| AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 (P000010) | Roche Molecular Systems, Inc. | 2001-07-05 |
| SALINE-FILLED BREAST IMPLANTS (P990074/S007) | Allergan | 2001-07-03 |
| TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG (P950029/S014) | MicroPort CRM USA, Inc. | 2001-07-03 |
| VISULAS 690S LASER AND VISULINK PDT ADAPTER (P990048/S002) | Carl Zeiss Meditec, AG | 2001-07-03 |
| COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012) | Roche Molecular Systems, Inc. | 2001-07-03 |
| BIODIVYSIO AS OTW (P000011/S002) | Abbott Vascular, Inc. | 2001-07-03 |
| TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043) | Boston Scientific Corp | 2001-06-29 |
| SYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM (P860004/S046) | Medtronic, Inc. | 2001-06-29 |
| POSTERIOR CHAMBER IOL'S (P970034/S009) | Aaren Scientific | 2001-06-29 |
| NEUROCYBERNETIC PROSTHESIS SYSTEM (P970003/S034) | LivaNova USA, Inc. | 2001-06-29 |
| HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S016) | Integra LifeSciences Corporation | 2001-06-29 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S011) | Biosense Webster, Inc. | 2001-06-27 |
| VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS (P960040/S023) | Boston Scientific | 2001-06-27 |
| CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM (P000005) | Rls Global AB | 2001-06-27 |
| CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES (P950005/S014) | Biosense Webster, Inc. | 2001-06-27 |
| INTERSTIM(R) THERAPY FOR URINARY CONTROL (P970004/S015) | Medtronic Neuromodulation | 2001-06-26 |
| VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145) | Biomerieux Vitek, Inc. | 2001-06-25 |
| ACTIVA TREMOR CONTROL SYSTEM (P960009/S017) | Medtronic, Inc. | 2001-06-22 |
| INTREL SPINAL CORD STIMULATION SYSTEM (P840001/S054) | Medtronic Neuromodulation | 2001-06-22 |
| CELSIUS II BIDIRECTIONAL DEFLECTING DIAGNOSTIC/ABLATION CATHETER (P950005/S013) | Biosense Webster, Inc. | 2001-06-22 |
| OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S001) | Beam-Med, Ltd. | 2001-06-21 |
| BONNIE & BYPASS SPEEDY PTCA CATHETER (P880027/S059) | Boston Scientific | 2001-06-21 |
| VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002 (P910001/S019) | Spectranetics Corp. | 2001-06-19 |
| IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000 (P930027/S004) | Siemens Healthcare Diagnostics, Inc. | 2001-06-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT (P000044/S002) | Ortho-Clinical Diagnostics, Inc. | 2001-06-18 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB (P800002/S012) | C.R. Bard, Inc. | 2001-06-18 |
| HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000 (P990075/S003) | Mentor Worldwide, LLC | 2001-06-18 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR (N17600/S018) | Davol Inc., Sub. C. R. Bard, Inc. | 2001-06-18 |
| NOVOSTE 40 MM BETA-CATH SYSTEM (P000018/S005) | Best Vascular, Inc. | 2001-06-15 |
| MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT (P920015/S022) | Medtronic, Inc. | 2001-06-15 |
| LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER (P960016/S004) | St Jude Medical | 2001-06-14 |
| CAPSURE SP NOVUS LEAD MODEL 5594 (P850089/S046) | Medtronic Cardiac Rhythm Disease Management | 2001-06-14 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S006) | Vascular Solutions, Inc. | 2001-06-14 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S004) | Medtronic Ats Medical, Inc. | 2001-06-14 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053) | Boston Scientific Corp | 2001-06-14 |
| MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL (P960040/S022) | Boston Scientific | 2001-06-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144) | Biomerieux Vitek, Inc. | 2001-06-13 |
| LCS TOTAL KNEE SYSTEM (P830055/S078) | Depuy, Inc. | 2001-06-13 |
| PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW3 (P910023/S052) | ABBOTT MEDICAL | 2001-06-13 |
| MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL (P920015/S021) | Medtronic, Inc. | 2001-06-11 |
| SHELLGEL(TM) SODIUM HYALURONATE (P000046/S001) | Anika Therapeutics, Inc. | 2001-06-11 |
| ORCHESTRA PROGRAMMER (P980049/S005) | MicroPort CRM USA, Inc. | 2001-06-08 |
| NIR(R) PREMOUNTED STENT SYSTEM (P980001/S033) | Boston Scientific Corp | 2001-06-07 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S033) | LivaNova USA, Inc. | 2001-06-07 |
| ANCURE(R) ENDOGRAFT(R) SYSTEM (P990017/S024) | Boston Scientific Corp | 2001-06-07 |
| UROLUME(R) ENDOPROSTHESIS (P920023/S014) | Boston Scientific Corp | 2001-06-07 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL) (P990064/S004) | Medtronic, Inc. | 2001-06-07 |
| TARGIS SYSTEM (P970008/S017) | Urologix, LLC | 2001-06-05 |
| ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY (P970020/S031) | Abbott Vascular, Inc. | 2001-06-05 |
| BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS (P000022/S006) | Medtronic Vascular | 2001-06-05 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008) | Medtimo, Inc. | 2001-06-05 |
| CORONARY DILATATION CATHETER (P810046/S208) | Advanced Cardiovascular Systems, Inc. | 2001-06-05 |