| NC MAXXUM PTCA CATHETER (P860019/S168) | Scimed Life Systems, Inc. | 2001-06-04 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG (P990012) | Roche Diagnostics Corp. | 2001-06-01 |
| R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT (P790017/S075) | Medtronic, Ireland | 2001-06-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S033) | Abbott Vascular, Inc. | 2001-06-01 |
| ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS (P970020/S030) | Abbott Vascular, Inc. | 2001-06-01 |
| THORATEC VENTRICULAR ASIST DEVICE (P870072/S012) | Thoratec Laboratories Corp. | 2001-06-01 |
| HEARTMATE XVE LVAS (P920014/S015) | Thoratec Corp | 2001-05-31 |
| VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142) | Biomerieux Vitek, Inc. | 2001-05-30 |
| TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S001) | Cerenovus, Inc. | 2001-05-30 |
| POLYTEF PASTE FOR INJECTION (N16420/S005) | Coloplast Corp. | 2001-05-30 |
| ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA (P000037) | On-X Life Technologies, Inc. | 2001-05-30 |
| S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S027) | Medtronic, Ireland | 2001-05-29 |
| NIR PREMOUNTED STENT SYSTEMS (P980001/S032) | Boston Scientific Corp | 2001-05-29 |
| WALLSTENT(R) ILLIAC ENDOPROSTHESIS (P940019/S007) | Boston Scientific Scimed, Inc. | 2001-05-29 |
| WALLSTENT(R) TRANSJUGLAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS (P930031/S009) | Boston Scientific Corp | 2001-05-29 |
| IMAGE CHECKER (CAD) SYSTEM, M1000 (P970058/S010) | Hologic, Inc. | 2001-05-29 |
| MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 (P980016/S016) | Medtronic Cardiac Rhythm Disease Management | 2001-05-25 |
| MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 (P980050/S003) | Medtronic, Inc. | 2001-05-25 |
| MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276 (P900061/S042) | Medtronic Cardiac Rhythm Disease Management | 2001-05-25 |
| AUTOCYTE PREP SYSTEM (P970018/S002) | Bd Diagnostic Systems | 2001-05-25 |
| PTCA CATHETERS (P860019/S174) | Scimed Life Systems, Inc. | 2001-05-25 |
| CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER (P950005/S012) | Biosense Webster, Inc. | 2001-05-25 |
| ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY (P950037/S017) | Biotronik, Inc. | 2001-05-24 |
| HIGHSAIL CORONARY DILATATION CATHETER (P810046/S207) | Advanced Cardiovascular Systems, Inc. | 2001-05-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PACK/CALIBRATOR/CONFIRMATORY KIT (P000044/S001) | Ortho-Clinical Diagnostics, Inc. | 2001-05-24 |
| ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEMS (P970020/S032) | Abbott Vascular, Inc. | 2001-05-24 |
| MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR (P980050/S004) | Medtronic, Inc. | 2001-05-22 |
| UVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM (P860003/S039) | Therakos Development Limited | 2001-05-22 |
| GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S002) | Animas Corp. | 2001-05-22 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S063) | Boston Scientific Corp | 2001-05-21 |
| OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS (P910066/S016) | Djo, LLC | 2001-05-18 |
| STINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE (P000020/S001) | Boston Scientific Corp | 2001-05-18 |
| ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS (N18033/S034) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2001-05-18 |
| NC MONORAIL PTCA CATHETER (P860019/S173) | Scimed Life Systems, Inc. | 2001-05-16 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 6900 MITRAL (P860057/S015) | Edwards Lifesciences, LLC | 2001-05-15 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S017) | Edwards Lifesciences, LLC | 2001-05-15 |
| PERFLUORON (P950018/S006) | Alcon Laboratories | 2001-05-15 |
| SALINE-FILLED BREAST IMPLANTS (P990074/S006) | Allergan | 2001-05-15 |
| GEM DR/GEM II DR/GEM II VR (P980016/S018) | Medtronic Cardiac Rhythm Disease Management | 2001-05-14 |
| MICRO JEWEL/JEWEL II (P900061/S044) | Medtronic Cardiac Rhythm Disease Management | 2001-05-14 |
| MEDTRONIC KAPPA 700/600 PULSE GENERATOR (P980035/S010) | Medtronic, Inc. | 2001-05-14 |
| VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141) | Biomerieux Vitek, Inc. | 2001-05-14 |
| LUMBAR I/F CAGE SYSTEM (P960025/S006) | Depuy Spine, Inc. | 2001-05-14 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S001) | Medtronic Ats Medical, Inc. | 2001-05-10 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S032) | LivaNova USA, Inc. | 2001-05-10 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S003) | Medtronic Ats Medical, Inc. | 2001-05-10 |
| APLIGRAF(R) (P950032/S023) | Organogenesis, Inc. | 2001-05-09 |
| ANEURX STENT GRAFT SYSTEM (P990020/S007) | Medtronic Vascular | 2001-05-09 |
| UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES WITH PLATE HAPTICS (P910058/S010) | Bausch & Lomb, Inc. | 2001-05-09 |
| PMMA ANTERIOR CHAMBER INTRAOCULAR LENS (P870013/S014) | Bausch & Lomb | 2001-05-08 |
| CUTTING BALLOON (P950020/S002) | Boston Scientific Corp | 2001-05-08 |
| PMMA ANTERIOR CHAMBER INTRAOCULAR LENS (P850059/S022) | Bausch & Lomb Surgical, Inc. | 2001-05-08 |
| UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS (P850059/S023) | Bausch & Lomb Surgical, Inc. | 2001-05-08 |
| UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL (P870013/S015) | Bausch & Lomb | 2001-05-08 |
| POSTERIOR CHAMBER INTRAOCULAR LENS (P790027/S065) | Bausch & Lomb | 2001-05-08 |
| UV-ABSORBING PMMA POSTERIOR CHAMBER IOLS (P790027/S066) | Bausch & Lomb | 2001-05-08 |
| MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM (P970020/S027) | Abbott Vascular, Inc. | 2001-05-07 |
| 9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE (P890003/S063) | Medtronic, Inc. | 2001-05-07 |
| BIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM (P000011/S001) | Abbott Vascular, Inc. | 2001-05-07 |
| MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0) (P890003/S062) | Medtronic, Inc. | 2001-05-07 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S001) | Animas Corp. | 2001-05-03 |
| S670 WITH D OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS, S660 WITH DISCRETE TECH OVER-THE-WIRE AND RAPID EXS (P970035/S026) | Medtronic, Ireland | 2001-05-03 |
| BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT SYSTEMS (P000022/S005) | Medtronic Vascular | 2001-05-03 |
| MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00 (P810002/S056) | ABBOTT MEDICAL | 2001-05-03 |
| BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM (P980048/S001) | Sulzer Spine-Tech | 2001-05-02 |
| PTCA CATHETER (P860019/S172) | Scimed Life Systems, Inc. | 2001-05-02 |
| UROLUME ENDOPROSTHESIS (P920023/S013) | Boston Scientific Corp | 2001-05-01 |
| NEUROCYBERNETIC PROSTHESIS SYSTEM (P970003/S031) | LivaNova USA, Inc. | 2001-05-01 |
| HEALTHTRONICS OSSATRON (P990086/S001) | Sanuwave, Inc. | 2001-05-01 |
| PTCA CATHETERS (P860019/S171) | Scimed Life Systems, Inc. | 2001-05-01 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S005) | Integra Lifesciences Corp. | 2001-04-30 |
| FLOSEAL MATRIX/MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S006) | Baxter Healthcare Corp | 2001-04-30 |
| MICRONY II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS (P970013/S001) | ABBOTT MEDICAL | 2001-04-30 |
| VIGOR SOFTWARE APPLICATION; VERSION 5.2 (P840068/S041) | Boston Scientific | 2001-04-30 |
| VIGOR SOFTWARE APPLICATION; VERSION 5.2 (P940031/S026) | Boston Scientific | 2001-04-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR (P000044) | Ortho-Clinical Diagnostics, Inc. | 2001-04-27 |
| VISX STAR EXCIMER LASER SYSTEM (P930016/S012) | Amo Manufacturing USA, LLC | 2001-04-27 |
| APLIGRAF(GRAFTSKIN) (P950032/S022) | Organogenesis, Inc. | 2001-04-26 |
| ARRAY(R) SILICONE MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES (P960028/S006) | Johnson & Johnson Surgical Vision, Inc. | 2001-04-25 |
| INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS (P940008/S016) | Boston Scientific | 2001-04-25 |
| SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S003) | GE Healthcare | 2001-04-24 |
| ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT (P890055/S012) | Intera Oncology | 2001-04-24 |
| BETA-CATH(TM) SYSTEM (P000018/S003) | Best Vascular, Inc. | 2001-04-24 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S014) | Boston Scientific Corp | 2001-04-24 |
| FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT (P990028/S001) | Genzyme Corp. | 2001-04-20 |
| HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM (P000032) | CooperSurgical, Inc. | 2001-04-20 |
| BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM (P980048) | Sulzer Spine-Tech | 2001-04-20 |
| HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM (P000040) | Axora Medical, Inc. | 2001-04-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS (P000014/S004) | Ortho-Clinical Diagnostics, Inc. | 2001-04-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS (P000014/S003) | Ortho-Clinical Diagnostics, Inc. | 2001-04-19 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL (P980040/S001) | Johnson & Johnson Surgical Vision, Inc. | 2001-04-18 |
| STAARVISC II (P000046) | Anika Therapeutics, Inc. | 2001-04-18 |
| PREMIER PACING SYSTEM (P850051/S056) | Medtronic, Inc. | 2001-04-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES (P900056/S062) | Boston Scientific Corp | 2001-04-17 |
| LCS TOTAL KNEE SYSTEM (P830055/S075) | Depuy, Inc. | 2001-04-17 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S061) | Boston Scientific Corp | 2001-04-13 |
| OPEN SAIL CORONARY DILATATION CATHETER (P810046/S206) | Advanced Cardiovascular Systems, Inc. | 2001-04-13 |
| ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER (N18033/S035) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2001-04-12 |
| NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM (P980001/S031) | Boston Scientific Corp | 2001-04-10 |
| FLOSEAL MATRIX HEMOSTATIC SEALANT (P990009/S007) | Baxter Healthcare Corp | 2001-04-10 |