| NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM (P980001/S030) | Boston Scientific Corp | 2001-04-10 |
| MCGHAN SALINE-FILLED BREAST IMPLANTS (P990074/S005) | Allergan | 2001-04-09 |
| MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER (P920032/S006) | Pace Medical | 2001-04-06 |
| FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S035) | Abbott Vascular | 2001-04-06 |
| BX VELOCITY STENT ON RAPTOR RAIL STENT DELIVERY SYSTEM (RX) (P900043/S026) | Cordis Corp. | 2001-04-06 |
| THINLINE II/FINELINE II STEROX PACING LEADS (P960004/S018) | Boston Scientific | 2001-04-06 |
| JEWEL AF SYSTEM (P980050/S001) | Medtronic, Inc. | 2001-04-06 |
| MAVERICK MONORAIL (P860019/S170) | Scimed Life Systems, Inc. | 2001-04-05 |
| VENTAK PRIZM IMPLANTABLE CARIOVERTER DEFIBRILLATORS (P960040/S021) | Boston Scientific | 2001-04-05 |
| CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A (P990080) | Johnson & Johnson Surgical Vision, Inc. | 2001-04-05 |
| VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE) (P910068/S001) | Air Products & Chemicals, Inc. | 2001-04-04 |
| S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S022) | Medtronic, Ireland | 2001-04-04 |
| DERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE) (P960052/S002) | Closure Medical Corp. | 2001-04-04 |
| BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM (P950002/S009) | Zimmer Spine, Inc. | 2001-04-03 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S003) | Carbon Medical Technologies, Inc. | 2001-04-02 |
| CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P940007/S006) | Advanced Medical Optics, Inc. | 2001-04-02 |
| VIBRANT D SOUNDBRIDGE SYSTEM (P990052/S003) | Med-El Elektromedizinische Gerate GmbH | 2001-04-02 |
| DIASORIN ETI-AB-EBK PLUS ASSAY (P990041) | DiaSorin, Inc. | 2001-03-30 |
| DIASORIN ETI MAK-2 PLUS ASSAY (P990038) | DiaSorin, Inc. | 2001-03-30 |
| DIASORIN ETI-CORE-IGMK PLUS ASSAY (P990044) | DiaSorin, Inc. | 2001-03-30 |
| DIASORIN ETI-AB-COREK PLUS ASSAY (P990045) | DiaSorin, Inc. | 2001-03-30 |
| IMX TACROLIMUS II (P970007/S002) | Abbott Laboratories | 2001-03-30 |
| DIASORIN ETI-AB-AUK PLUS ASSAY (P990042) | DiaSorin, Inc. | 2001-03-30 |
| HEALTHTRONICS OSSATRON (P990086/S002) | Sanuwave, Inc. | 2001-03-30 |
| AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER (P880065/S005) | Boston Scientific Corp | 2001-03-27 |
| PERFLUORON (P950018/S005) | Alcon Laboratories | 2001-03-27 |
| PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P880027/S058) | Boston Scientific | 2001-03-27 |
| RADIUS(TM) CORONARY STENT WITH DELIVERY SYSTEM (P970061/S010) | Boston Scientific Scimed, Inc. | 2001-03-27 |
| PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P860019/S169) | Scimed Life Systems, Inc. | 2001-03-27 |
| NIR(R) PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S029) | Boston Scientific Corp | 2001-03-27 |
| SOFLENS (POLYMACON) CONTACT LENSES (N16895/S087) | Bausch & Lomb, Inc. | 2001-03-26 |
| BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY (P960011/S004) | Altacor , Ltd. | 2001-03-23 |
| VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE (P990037/S003) | Vascular Solutions, Inc. | 2001-03-22 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026) | Animas Corp. | 2001-03-22 |
| ADATO SIL-OIL 5000 SILICONE OIL (P910071/S005) | Bausch & Lomb | 2001-03-22 |
| ROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER (P900056/S060) | Boston Scientific Corp | 2001-03-21 |
| HOME ACCESS HEPATITIS C CHECK TEST (P980046/S004) | Pwn Health Chicago, LLC | 2001-03-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS (P000014/S001) | Ortho-Clinical Diagnostics, Inc. | 2001-03-20 |
| S670 AND S660 WITH DISCRETE TECHNOLOGY CORONARY STENT SYSTEMS (P970035/S025) | Medtronic, Ireland | 2001-03-19 |
| VISX STAR S2/S3 EXCIMER LASER SYSTEM (P930016/S013) | Amo Manufacturing USA, LLC | 2001-03-19 |
| DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S024) | Medtronic, Ireland | 2001-03-19 |
| BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS (P000022/S004) | Medtronic Vascular | 2001-03-19 |
| MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL) (P960036/S004) | Ioltech, S.A. | 2001-03-16 |
| SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK) (P990078/S004) | Sunrise Technologies, Inc. | 2001-03-16 |
| SJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT (P810002/S055) | ABBOTT MEDICAL | 2001-03-16 |
| MAGIC WALLSTENT ENDOPROSTHESIS (P980009/S006) | Boston Scientific Scimed, Inc. | 2001-03-16 |
| FLOSEAL(R) MATRIX/PROCEED(TM) HEMOSTATIC SEALANT (P990009/S005) | Baxter Healthcare Corp | 2001-03-15 |
| MEDTRONIC VISION SOFTWARE SERIES 4.0 (P900061/S043) | Medtronic Cardiac Rhythm Disease Management | 2001-03-15 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S005) | Nidek Co., Ltd. | 2001-03-15 |
| MEDTRONIC VISION SOFTWARE SERIES 4.0 (P980016/S017) | Medtronic Cardiac Rhythm Disease Management | 2001-03-15 |
| BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S035) | Abiomed Cardiovascular, Inc. | 2001-03-15 |
| BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S002) | Medtronic Vascular | 2001-03-15 |
| VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE (P990037/S002) | Vascular Solutions, Inc. | 2001-03-14 |
| VASOSEAL EXTRA SECURITY (ES) DEVICE (P920004/S014) | St. Jude Medical, Inc. | 2001-03-13 |
| ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S034) | Abiomed Cardiovascular, Inc. | 2001-03-12 |
| ANGIO-SEAL(TM) VASCULAR CLOSURE DEVICE, 8F/6F (P930038/S030) | Terumo Medical Corporation | 2001-03-12 |
| VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140) | Biomerieux Vitek, Inc. | 2001-03-09 |
| RAPID FFN FOR THE TLI SYSTEM (P920048/S003) | Hologic, Inc. | 2001-03-09 |
| PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR (P850007/S026) | Orthofix, Inc. | 2001-03-09 |
| BETA-CATH(TM) SYSTEM (P000018/S010) | Best Vascular, Inc. | 2001-03-09 |
| BIOLON(TM) 1% SODIUM HYALURONATE (P960011/S006) | Altacor , Ltd. | 2001-03-08 |
| MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953 - SERIES 1.1 SOFTWARE (P980035/S009) | Medtronic, Inc. | 2001-03-08 |
| MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE (P970012/S010) | Medtronic, Inc. | 2001-03-08 |
| DEMA, DIVA AND AFM PULSE GENERATORS (P990001/S006) | Medtronic, Inc. | 2001-03-07 |
| TACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX (P000009/S001) | Biotronik, Inc. | 2001-03-05 |
| TCI HEARTMATE VE LVAS (P920014/S014) | Thoratec Corp | 2001-03-02 |
| VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE (P880086/S082) | ABBOTT MEDICAL | 2001-03-02 |
| MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM (P970020/S028) | Abbott Vascular, Inc. | 2001-03-02 |
| NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM (P970051/S013) | Cochlear Americas | 2001-03-02 |
| POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER (P810046/S204) | Advanced Cardiovascular Systems, Inc. | 2001-03-02 |
| VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE (P910023/S051) | ABBOTT MEDICAL | 2001-03-02 |
| VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE (P830045/S075) | St. Jude Medical, Inc. | 2001-03-02 |
| LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S002) | Depuy Spine, Inc. | 2001-02-28 |
| FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT (P990009/S004) | Baxter Healthcare Corp | 2001-02-28 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007) | Edwards Lifesciences, LLC | 2001-02-27 |
| MODEL 150 NEUROCYBERNETIC PROSTHESIS SYSTEM PROGRAMMING SOFTWARE (VERSION 6) (P970003/S030) | LivaNova USA, Inc. | 2001-02-27 |
| TMJ FOSSA-EMINENCE PROSTHESIS(TM) (P000035) | Nexus CMF, LLC | 2001-02-27 |
| SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS (P990075/S001) | Mentor Worldwide, LLC | 2001-02-27 |
| DISCOVERY(TM)/MERIDIAN(TM) (P940031/S025) | Boston Scientific | 2001-02-26 |
| MULTI-LINK RX TETRA CORONARY STENT SYSTEM (P970020/S029) | Abbott Vascular, Inc. | 2001-02-26 |
| SMARTMAGNET(TM) (P980016/S013) | Medtronic Cardiac Rhythm Disease Management | 2001-02-22 |
| EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S012) | Bioventus, LLC | 2001-02-21 |
| NIR PREMOUNTED STENT SYSTEMS (P980001/S028) | Boston Scientific Corp | 2001-02-21 |
| MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM (P840001/S047) | Medtronic Neuromodulation | 2001-02-21 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S022) | Corcym S.r.l. | 2001-02-16 |
| VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P990085) | Johnson & Johnson Vision Care, Inc. | 2001-02-16 |
| NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS (P980001/S024) | Boston Scientific Corp | 2001-02-16 |
| OPTICAL BIOPSY(TM) SYSTEM (P990050/S001) | Spectra Science | 2001-02-16 |
| NIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEM (P980001/S022) | Boston Scientific Corp | 2001-02-16 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S001) | Closure Medical Corp. | 2001-02-15 |
| CHILLI COOLED ABLATION SYSTEM (P990054/S001) | Boston Scientific Corp | 2001-02-15 |
| ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS (P990017/S012) | Boston Scientific Corp | 2001-02-15 |
| UVAR(R) XTS(R) PHOTOPHERESIS SYSTEM (P860003/S038) | Therakos Development Limited | 2001-02-15 |
| THINLINE II/FINELINE II STEROX PACING LEADS (P960004/S017) | Boston Scientific | 2001-02-15 |
| THERMA CHOICE UTERINE BALLON THERAPY SYSTEM (P970021/S004) | Gynecare, Inc. | 2001-02-13 |
| BETA-CATH(TM)SYSTEM (P000018/S007) | Best Vascular, Inc. | 2001-02-13 |
| VISCOAT(R) SODIUM HYALURONATE (P840064/S022) | Alcon Laboratories | 2001-02-13 |
| MEDTRONIC GEM III AT MODEL 7276 (ICD) (P980050/S002) | Medtronic, Inc. | 2001-02-13 |
| DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA (P890047/S013) | Alcon Research, Ltd. | 2001-02-13 |
| COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016) | Ge Medical Systems Information Technologies | 2001-02-09 |