| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S033) | ABBOTT MEDICAL | 1998-10-21 |
| PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST (P900052/S005) | Smiths Medical Asd, Inc. | 1998-10-20 |
| ORTHOLOGIC 1000 SC (P910066/S012) | Djo, LLC | 1998-10-16 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S011) | LivaNova USA, Inc. | 1998-10-16 |
| ACS RX SOLARIS CORONARY DILATATION CATHETER (P810046/S192) | Advanced Cardiovascular Systems, Inc. | 1998-10-16 |
| OSTEOPAL (P810020/S005) | Smith & Nephew Richards, Inc. | 1998-10-15 |
| TENDRIL DX ENDOCARDIAL PACING LEADS (P960013/S004) | ABBOTT MEDICAL | 1998-10-15 |
| TEMPO AND META PULSE GENERATORS (P900070/S023) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1998-10-15 |
| SYNCHRONY, SOLUS, PHOENIX, PARAGON AND TRILOGY FAMILY OF PULSE GENERATORS (P880086/S052) | ABBOTT MEDICAL | 1998-10-15 |
| PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS (P960030/S003) | ABBOTT MEDICAL | 1998-10-15 |
| PARAGON II AND PHOENIX PULSE GENERATORS (P830045/S060) | St. Jude Medical, Inc. | 1998-10-15 |
| MEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.1 (P970012/S006) | Medtronic, Inc. | 1998-10-15 |
| REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS (P880006/S028) | St. Jude Medical, Inc. | 1998-10-15 |
| GELFOAM STERILE SPONGE (N18286/S010) | Pfizer, Inc. | 1998-10-14 |
| PROSTATRON (P950014/S016) | Urologix, Inc. | 1998-10-14 |
| ACRYSOF(R) ACRYLIC POSTERIOR CHAMBER IOL (P930014/S005) | Alcon Laboratories, Inc. | 1998-10-09 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016) | Medtronic Cardiac Rhythm Disease Management | 1998-10-09 |
| CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER (P950029/S002) | MicroPort CRM USA, Inc. | 1998-10-09 |
| MEDTRONIC CAPSURE SP MODEL 4523M (P830061/S029) | Medtronic Cardiac Rhythm Disease Management | 1998-10-09 |
| PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS (P960030/S004) | ABBOTT MEDICAL | 1998-10-08 |
| SVS APEX AND SVS APEX PLUS EXCIMER LASER WORKSTATIONS (P930034/S008) | Alcon Laboratories, Inc. | 1998-10-08 |
| THE HEART LASER CO2 TMR SYSTEM (P950015/S001) | Laser Engineering Heart, Inc. | 1998-10-06 |
| MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520 (P960014) | Global Therapeutics, Inc. | 1998-10-05 |
| MEDTRONIC(R) MODEL 7227CX GEM (TM) IMPLANTABLE CARDIOVERTER (P900061/S035) | Medtronic Cardiac Rhythm Disease Management | 1998-10-05 |
| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S016) | Boston Scientific | 1998-10-02 |
| SWEET TIP(R) RX STEROID ELUTING LEAD (P960006) | Boston Scientific | 1998-10-02 |
| SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODELS L15IU AND L16IU (P910061/S004) | Bausch & Lomb | 1998-10-02 |
| UROLUME ENDOPROSTHESIS (P920023/S006) | Boston Scientific Corp | 1998-10-02 |
| SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S144) | Scimed Life Systems, Inc. | 1998-10-01 |
| TORONTO SPV VALVE (P970030/S001) | St. Jude Medical, Inc. | 1998-09-30 |
| SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S141) | Scimed Life Systems, Inc. | 1998-09-30 |
| MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS (P970035/S005) | Medtronic, Ireland | 1998-09-30 |
| MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS (P970035/S007) | Medtronic, Ireland | 1998-09-30 |
| NOVACOR LVAS (P980012) | Worldheart, Inc. | 1998-09-29 |
| MAGIC WALLSTENT ENDOPROTHESIS (P980009) | Boston Scientific Scimed, Inc. | 1998-09-29 |
| SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920) (P940007/S004) | Advanced Medical Optics, Inc. | 1998-09-29 |
| HEARTMATE(R) VE LVAS (P920014/S007) | Thoratec Corp | 1998-09-29 |
| SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S004) | Boston Scientific Scimed, Inc. | 1998-09-25 |
| AUDALLION BEAMFORMER (P840024/S077) | Cochlear Americas | 1998-09-25 |
| MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034) | Aaren Scientific | 1998-09-25 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S017) | Terumo Medical Corporation | 1998-09-25 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S010) | LivaNova USA, Inc. | 1998-09-25 |
| PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 (P980017) | Possis Medical, Inc. | 1998-09-25 |
| DAKO HERCEPTEST (P980018) | Agilent Technologies Singapore (International) Pte , Ltd. | 1998-09-25 |
| LOGICON CARIES DETECTOR (P980025) | Carestream Dental, LLC | 1998-09-25 |
| AUDALLION BEAMFORMER (P890027/S046) | Cochlear Americas | 1998-09-25 |
| OMNISCIENCE AND OMNICARBON CARDIAC VALVES (P830039/S008) | Medical Cv, Inc. | 1998-09-25 |
| CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT (P890017/S005) | Cordis US Corporation | 1998-09-25 |
| TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038/S001) | Beckman Coulter, Inc. | 1998-09-24 |
| MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE (P890003/S054) | Medtronic, Inc. | 1998-09-24 |
| ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM (P950037/S004) | Biotronik, Inc. | 1998-09-24 |
| AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS (P890019/S005) | Diasorin | 1998-09-22 |
| MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S004) | Medtronic, Inc. | 1998-09-22 |
| MODULARIS LITHO (P870018/S021) | Siemens Corp. | 1998-09-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S001) | Cochlear Americas | 1998-09-21 |
| MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S005) | Medtronic, Inc. | 1998-09-18 |
| NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE (P790017/S067) | Medtronic, Ireland | 1998-09-18 |
| MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S004) | Medtronic, Inc. | 1998-09-18 |
| DIASORIN ETI-HA-IGMK PLUS (P890014/S002) | DiaSorin, Inc. | 1998-09-16 |
| SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S143) | Scimed Life Systems, Inc. | 1998-09-16 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER (P850064/S014) | Bunnell, Inc. | 1998-09-16 |
| MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER (P870015/S030) | Medstone Intl., Inc. | 1998-09-16 |
| PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST (P900052/S006) | Smiths Medical Asd, Inc. | 1998-09-15 |
| SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S003) | Boston Scientific Scimed, Inc. | 1998-09-15 |
| ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE (P890055/S006) | Intera Oncology | 1998-09-15 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S083) | Biomerieux Vitek, Inc. | 1998-09-15 |
| ECONOLITH(TM) LITHOTRIPTER (P950043/S005) | Medispec, Ltd. | 1998-09-14 |
| ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001) | Wrightmedicaltechnologyinc | 1998-09-11 |
| LITHOTRON ULTRA LITHOSTRIPSY SYSTEM (P970019/S004) | Healthtronics Surgical Services, Inc. | 1998-09-11 |
| BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID (P960011/S001) | Altacor , Ltd. | 1998-09-09 |
| UV ABSORBING POSTERIOR CHAMBER IOL (P810018/S036) | Alcon Laboratories | 1998-09-04 |
| APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P880006/S027) | St. Jude Medical, Inc. | 1998-09-04 |
| ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S003) | Alcon Laboratories, Inc. | 1998-09-04 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE (P960058/S005) | Advanced Bionics | 1998-09-04 |
| 3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV (P830040/S026) | Alcon Research, Ltd. | 1998-09-04 |
| APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P880086/S045) | ABBOTT MEDICAL | 1998-09-04 |
| IRIDOCAPSULAR INTRAOCULAR LENS (P800049/S008) | Alcon | 1998-09-04 |
| 14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE (P960042/S002) | Spectranetics (Philips) | 1998-09-04 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P810001/S013) | Alcon | 1998-09-04 |
| POSTERIOR CHAMBER INTRAOCULAR LENS (P880010/S019) | Alcon Laboratories | 1998-09-04 |
| POSTERIOR CHAMBER IOL (P840060/S026) | Alcon Laboratories | 1998-09-04 |
| CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S006) | Advanced Bionics Corp. | 1998-09-04 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P880087/S007) | Alcon Laboratories | 1998-09-04 |
| UV ABSORBING POST.CHAM.IOL (P810032/S049) | Alcon Laboratories | 1998-09-04 |
| APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P830045/S056) | St. Jude Medical, Inc. | 1998-09-04 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P820035/S015) | Alcon | 1998-09-04 |
| VENTRITEK CONTOUR II TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P910023/S035) | ABBOTT MEDICAL | 1998-09-03 |
| APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P880086/S046) | ABBOTT MEDICAL | 1998-09-03 |
| TEMPO PULSE GENERATORS (P900070/S022) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1998-09-03 |
| ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S024) | Boston Scientific Corp | 1998-09-02 |
| LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES (P930012/S011) | Progressive Angioplasty Systems, Inc. | 1998-09-02 |
| PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM (P960043/S005) | Abbott Vascular, Inc. | 1998-09-02 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S032) | Therakos Development Limited | 1998-09-01 |
| CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS (P930039/S005) | Medtronic, Inc. | 1998-09-01 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S002) | Medtronic, Inc. | 1998-09-01 |
| VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION (P960040/S006) | Boston Scientific | 1998-08-31 |
| ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER (P860008/S016) | Cardio Command | 1998-08-28 |
| BONNIE (TM) PTCA CATHERS (P880027/S052) | Boston Scientific | 1998-08-27 |
| DEPUY 3 BONE CEMENT (P960001/S007) | Depuy, Inc. | 1998-08-27 |
| MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB (P830061/S027) | Medtronic Cardiac Rhythm Disease Management | 1998-08-27 |