| TECHNOLAS(R)217A OPHTHALMIC EXCIMER LASER SYSTEM (P990027/S003) | Technolas Perfect Vision GmbH | 2001-09-25 |
| SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017) | Hologic, Inc. | 2001-09-25 |
| MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) (P890057/S014) | ZOLL Medical Corporation | 2001-09-24 |
| DEFLUX INJECTABLE GEL (P000029) | Palette Life Sciences | 2001-09-24 |
| BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM (P900043/S028) | Cordis Corp. | 2001-09-21 |
| BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM (P900043/S027) | Cordis Corp. | 2001-09-21 |
| MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468 (P990074/S009) | Allergan | 2001-09-21 |
| ANCURE ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS (P990017/S011) | Boston Scientific Corp | 2001-09-20 |
| NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S037) | Boston Scientific Corp | 2001-09-20 |
| VASOSEAL ES AND VHD DEVICES (P920004/S015) | St. Jude Medical, Inc. | 2001-09-20 |
| PROSTATRON (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR (P950014/S021) | Urologix, Inc. | 2001-09-19 |
| LENEFILCON A HYDROPHILIC CONTACT LENSES (P990085/S001) | Johnson & Johnson Vision Care, Inc. | 2001-09-19 |
| LUMBAR I/F CAGE SYSTEM (P960025/S007) | Depuy Spine, Inc. | 2001-09-17 |
| PHEMFILCON A SOFT (HYCROPHILIC) CONTACT LENS (P830037/S044) | Alcon Laboratories, Inc. | 2001-09-14 |
| APLIGRAF (GRAFTSKIN) (P950032/S026) | Organogenesis, Inc. | 2001-09-14 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S010) | Biocontrol Technology, Inc. | 2001-09-13 |
| SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S005) | GE Healthcare | 2001-09-12 |
| EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER (P950037/S021) | Biotronik, Inc. | 2001-09-10 |
| HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM (P000032/S001) | CooperSurgical, Inc. | 2001-09-07 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S016) | Medtronic Neuromodulation | 2001-09-07 |
| SCIMED PTCA CATHETERS (P860019/S176) | Scimed Life Systems, Inc. | 2001-09-07 |
| SCHNEIDER PTCA CATHETERS (P880027/S061) | Boston Scientific | 2001-09-07 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL (P900056/S064) | Boston Scientific Corp | 2001-09-07 |
| SOUNDTEC DIRECT SYSTEM (P010023) | Ototronix, LLC | 2001-09-07 |
| MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE (P910023/S054) | ABBOTT MEDICAL | 2001-09-05 |
| MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE (P830045/S077) | St. Jude Medical, Inc. | 2001-09-05 |
| MEDTRONIC GEM DR MODEL 7271 (P980016/S020) | Medtronic Cardiac Rhythm Disease Management | 2001-09-05 |
| SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY (P990075/S004) | Mentor Worldwide, LLC | 2001-09-05 |
| MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER (P900061/S046) | Medtronic Cardiac Rhythm Disease Management | 2001-09-05 |
| MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE (P880086/S084) | ABBOTT MEDICAL | 2001-09-05 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S035) | LivaNova USA, Inc. | 2001-09-04 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S006) | Nidek Co., Ltd. | 2001-09-04 |
| EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) (P900009/S013) | Bioventus, LLC | 2001-09-04 |
| TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM (P000009/S002) | Biotronik, Inc. | 2001-09-04 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S006) | Animas Corp. | 2001-09-04 |
| ORCEL BILAYERED CELLULAR MATRIX (P010016) | Forticell Bioscience | 2001-08-31 |
| TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S015) | Shire Regenerative Medicine | 2001-08-30 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S012) | Gen-Probe, Inc. | 2001-08-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021) | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS (P000014/S002) | Ortho-Clinical Diagnostics, Inc. | 2001-08-29 |
| MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY) (P980050/S006) | Medtronic, Inc. | 2001-08-29 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM (P930038/S031) | Terumo Medical Corporation | 2001-08-28 |
| PROSORBA COLUMN (P850020/S014) | Fresenius Hemocare, Inc. | 2001-08-28 |
| GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S005) | Animas Corp. | 2001-08-28 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015) | Medtronic, Inc. | 2001-08-28 |
| PERCUTANEOUS CORONARY DILATATION CATHETERS (P810046/S209) | Advanced Cardiovascular Systems, Inc. | 2001-08-22 |
| NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S011) | Best Vascular, Inc. | 2001-08-22 |
| MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS (P980035/S011) | Medtronic, Inc. | 2001-08-22 |
| NIR PREMOUNTED STENT SYSTEMS (P980001/S036) | Boston Scientific Corp | 2001-08-21 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025) | Med-El Corp. | 2001-08-20 |
| BARD STINGER ABLATION CATHETERS (P000020/S003) | Boston Scientific Corp | 2001-08-20 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S025) | Boston Scientific Corp | 2001-08-17 |
| ANCURE(R) ENDOGRAFT(R) SYSTEM (P990017/S020) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S015) | Boston Scientific Corp | 2001-08-17 |
| ENDOVASCULAR SOLUTIONS ANCURE ENDOGRAFT SYSTEM (P990017/S027) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S023) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S021) | Boston Scientific Corp | 2001-08-17 |
| HYSKON HYSTEROSCOPY FLUID (N17511/S014) | Coopervision Surgical | 2001-08-17 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S013) | Medtronic Neuromodulation | 2001-08-17 |
| WAVSTAT OPTICAL BIOPSY SYTEM (P990050/S002) | Spectra Science | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S016) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S017) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S022) | Boston Scientific Corp | 2001-08-17 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S026) | Boston Scientific Corp | 2001-08-17 |
| SCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S009) | Boston Scientific Scimed, Inc. | 2001-08-16 |
| MAGIC WALLSTENT(R) ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S008) | Boston Scientific Scimed, Inc. | 2001-08-16 |
| MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S007) | Boston Scientific Scimed, Inc. | 2001-08-16 |
| NIR CORONARY STENT WITH DELIVERY SYSTEM (P980001/S035) | Boston Scientific Corp | 2001-08-16 |
| HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (N17752/S038) | Ciba Vision Corporation | 2001-08-16 |
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S004) | Innovative Medical Systems, Inc. | 2001-08-15 |
| CLOSER / CLOSER S PERCUTANEOUS VASCULAR SURGERY DEVICES (P960043/S032) | Abbott Vascular, Inc. | 2001-08-15 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S034) | Abbott Vascular, Inc. | 2001-08-14 |
| MEDTRONIC MODEL 7424 ITREL(R) II, MODEL 7425 ITREL(R) III, AND MODEL 7427 SYNEEDRGY SPINAL CORD STIMULATION SYSTEMS (P840001/S055) | Medtronic Neuromodulation | 2001-08-14 |
| SCIMED PTCA CATHETERS (P860019/S175) | Scimed Life Systems, Inc. | 2001-08-14 |
| RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S011) | Boston Scientific Scimed, Inc. | 2001-08-13 |
| SCIMED TIPS WALLSTENT SYSTEM (P930031/S010) | Boston Scientific Corp | 2001-08-13 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S066) | Boston Scientific Corp | 2001-08-13 |
| ILIAC WALLSTENT SYSTEM (P940019/S008) | Boston Scientific Scimed, Inc. | 2001-08-13 |
| FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM) (P990009/S009) | Baxter Healthcare Corp | 2001-08-10 |
| APLIGRAF (GRAFTSKIN) (P950032/S025) | Organogenesis, Inc. | 2001-08-10 |
| ACTIVA TREMOR CONTROL THERAPY SYSTEM (P960009/S020) | Medtronic, Inc. | 2001-08-10 |
| INTEGRA/DERMAL REGENERATION TEMPLATE (P900033/S006) | Integra Lifesciences Corp. | 2001-08-10 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S007) | Integra Lifesciences Corp. | 2001-08-10 |
| PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY) (P990033/S002) | Ceramed Corp. | 2001-08-09 |
| MENTOR SALINE-FILLED BREAST IMPLANTS (P990075/S006) | Mentor Worldwide, LLC | 2001-08-09 |
| MEDTRONIC PACING LEADS (P830061/S032) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MEDTRONIC PACING LEADS (P850089/S047) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MEDTRONIC MODEL 7250 ARRHYTHMIA MANAGEMENT DEVICE (P980050/S007) | Medtronic, Inc. | 2001-08-08 |
| CAPSUREFIX (R) (P930039/S010) | Medtronic, Inc. | 2001-08-08 |
| GEM DR/GEM II DR/GEM II VR (P980016/S019) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS (P990074/S008) | Allergan | 2001-08-08 |
| MICRO JEWEL/JEWEL II (P900061/S045) | Medtronic Cardiac Rhythm Disease Management | 2001-08-08 |
| MEDTRONIC PACING LEADS (P890003/S064) | Medtronic, Inc. | 2001-08-08 |
| MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695 (P950024/S004) | Medtronic, Inc. | 2001-08-08 |
| MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT (P920015/S023) | Medtronic, Inc. | 2001-08-08 |
| PERFLUORON (P950018/S007) | Alcon Laboratories | 2001-08-07 |
| ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS (P950021/S003) | Siemens Healthcare Diagnostics | 2001-08-06 |
| ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS (P840001/S053) | Medtronic Neuromodulation | 2001-08-06 |
| INTERSTIM(R) THERAPY FOR URINARY CONTROL (P970004/S012) | Medtronic Neuromodulation | 2001-08-06 |
| THINPREP(R) 2000 SYSTEM (P950039/S007) | Hologic, Inc. | 2001-08-06 |