| RAY TFC DEVICE WITH INSTRUMENTATION (P950019/S004) | Stryker Spine | 1998-08-27 |
| GORE-TEX(TM) SUTURE (P820083/S025) | W. L. Gore & Associates, Inc. | 1998-08-27 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S037) | Boston Scientific | 1998-08-26 |
| DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE) (P960052) | Closure Medical Corp. | 1998-08-26 |
| CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS (P860057/S006) | Edwards Lifesciences, LLC | 1998-08-26 |
| VIGOR PACEMAKERS, MODELS 460 AND 1130 (P940031/S014) | Boston Scientific | 1998-08-26 |
| LITHOSTAR MULTILINE (P870018/S017) | Siemens Corp. | 1998-08-26 |
| LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE (P930012/S012) | Progressive Angioplasty Systems, Inc. | 1998-08-25 |
| SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S140) | Scimed Life Systems, Inc. | 1998-08-24 |
| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S017) | Boston Scientific | 1998-08-21 |
| DORNIER COMPACT DELTA LITHOTRIPTER (P840008/S066) | Dornier Medtech America, Inc. | 1998-08-21 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S010) | Cordis Corp. | 1998-08-20 |
| MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S006) | Medtronic, Inc. | 1998-08-20 |
| HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE (P790007/S014) | Medtronic Heart Valves | 1998-08-20 |
| THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION (P950015) | Laser Engineering Heart, Inc. | 1998-08-20 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S129) | Scimed Life Systems, Inc. | 1998-08-20 |
| HANCOCK PORCINE BIOPROSTHETIC HEART VALVE (P870078/S004) | Medtronic, Inc. | 1998-08-20 |
| PROSTATRON (P950014/S015) | Urologix, Inc. | 1998-08-19 |
| ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. (P970024) | MicroPort CRM USA, Inc. | 1998-08-19 |
| SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S008) | Baxter Healthcare Corporation | 1998-08-18 |
| ADEZA FETAL FIBRONECTIN EIK (P920048/S002) | Hologic, Inc. | 1998-08-14 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL) (N50510/S081) | Biomerieux Vitek, Inc. | 1998-08-14 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S012) | Medtronic, Inc. | 1998-08-14 |
| PHYSIO-STIM BONE GROWTH STIMULATOR (P850007/S023) | Orthofix, Inc. | 1998-08-14 |
| TRANSCYTE (P960007/S008) | Shire Regenerative Medicine | 1998-08-14 |
| ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM (P950037/S003) | Biotronik, Inc. | 1998-08-13 |
| PHYSIO-STIM BONE GROWTH STIMULATOR (P850007/S022) | Orthofix, Inc. | 1998-08-13 |
| ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S024) | Boston Scientific | 1998-08-13 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S002) | Biotronik, Inc. | 1998-08-13 |
| SUREFIX TM MODEL 5072 LEAD (P930039/S006) | Medtronic, Inc. | 1998-08-12 |
| CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT. (P960034) | Abbott Medical Optics, Inc. | 1998-08-12 |
| CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS (P850089/S039) | Medtronic Cardiac Rhythm Disease Management | 1998-08-12 |
| MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S001) | Medtronic, Inc. | 1998-08-12 |
| MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB (P830061/S028) | Medtronic Cardiac Rhythm Disease Management | 1998-08-12 |
| MODEL 6943 AND 6945 (P920015/S014) | Medtronic, Inc. | 1998-08-12 |
| MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE (P890003/S055) | Medtronic, Inc. | 1998-08-12 |
| NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM (P980001) | Boston Scientific Corp | 1998-08-11 |
| SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S146) | Scimed Life Systems, Inc. | 1998-08-10 |
| CHARGER PTCA DILATATION CATHETERS (P880003/S074) | Cordis Corp. | 1998-08-10 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) (P800002/S011) | C.R. Bard, Inc. | 1998-08-10 |
| AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S015) | Davol Inc., Sub. C. R. Bard, Inc. | 1998-08-10 |
| CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S006) | Edwards Lifesciences, LLC | 1998-08-07 |
| COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P910020/S023) | Boston Scientific | 1998-08-06 |
| SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S147) | Scimed Life Systems, Inc. | 1998-08-06 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S033) | Medtronic Cardiac Surgery | 1998-08-06 |
| COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P830026/S073) | Boston Scientific | 1998-08-06 |
| SHARPX (P980015) | Innovative Medical Systems, Inc. | 1998-08-06 |
| ROTAWIRE FLOPPY GOLD GUIDE WIRE/ROTABLATOR SYSTEMS GUIDE WIRE LINE (P900056/S022) | Boston Scientific Corp | 1998-08-06 |
| ACS MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTH (P970020/S001) | Abbott Vascular, Inc. | 1998-08-04 |
| CORDIS TITAN & TITAL XL DILATION CATHETERS (P880003/S071) | Cordis Corp. | 1998-08-04 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S012) | Cordis Corp. | 1998-08-04 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S036) | Boston Scientific | 1998-07-31 |
| VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS (P910077/S023) | Boston Scientific | 1998-07-31 |
| ACS RX ESPRIT CORONARY DILATION CATHETER (P810046/S190) | Advanced Cardiovascular Systems, Inc. | 1998-07-30 |
| KREMER LASER SYSTEM (P970005) | Lasersight Technologies, Inc. | 1998-07-30 |
| PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004) | Smith & Nephew Richards, Inc. | 1998-07-30 |
| SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S136) | Scimed Life Systems, Inc. | 1998-07-29 |
| NIC2800 NEEDLE DISPOSAL SYSTEM (P970036/S002) | Nic , Ltd. | 1998-07-29 |
| NEUROCONTROL FREEHAND SYSTEM(R) (P950035/S002) | Biocontrol Technology, Inc. | 1998-07-28 |
| UROLOGIC TARGIS SYSTEM (P970008/S006) | Urologix, LLC | 1998-07-27 |
| EBI BONE HEALING SYSTEM(R) (P790002/S019) | Ahp Eos Buyer, Inc. | 1998-07-27 |
| EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S041) | Ahp Eos Buyer, Inc. | 1998-07-24 |
| MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S015) | Boston Scientific | 1998-07-24 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S043) | ABBOTT MEDICAL | 1998-07-23 |
| DIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE) (P950005/S002) | Biosense Webster, Inc. | 1998-07-22 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S002) | Cochlear Americas | 1998-07-22 |
| HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD (P940005/S002) | Advanced Technology Laboratories, Inc. | 1998-07-21 |
| XILLIX-LIFE-LUNG (P950042/S001) | Novadaq Technologies, Inc. | 1998-07-21 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S007) | Thoratec Laboratories Corp. | 1998-07-20 |
| UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S (P880091/S011) | Staar Surgical Co. | 1998-07-20 |
| UROLOGIC TARGIS SYSTEM (P970008/S008) | Urologix, LLC | 1998-07-17 |
| TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S008) | Abbott Vascular, Inc. | 1998-07-17 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S016) | Terumo Medical Corporation | 1998-07-17 |
| THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2 (P960018) | Healthcare Products Plus, Inc. | 1998-07-16 |
| BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID (P960011) | Altacor , Ltd. | 1998-07-16 |
| SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061) | Boston Scientific Scimed, Inc. | 1998-07-16 |
| ACS: CENTAUR AFP IMMUNOASSAY (P930036/S001) | Siemens Healthcare Diagnostics, Inc. | 1998-07-15 |
| UROLUME(TM)ENDOPROSTHESIS (P920023/S004) | Boston Scientific Corp | 1998-07-15 |
| MODEL UV65 SERIES ANTERIOR CHAMBER LENSES (P880070/S008) | Abbott Medical Optics, Inc. | 1998-07-15 |
| MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S070) | Advanced Medical Optics, Inc. | 1998-07-15 |
| APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P830045/S058) | St. Jude Medical, Inc. | 1998-07-14 |
| POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S (P880086/S048) | ABBOTT MEDICAL | 1998-07-14 |
| MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE (P890003/S057) | Medtronic, Inc. | 1998-07-14 |
| POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S (P880086/S049) | ABBOTT MEDICAL | 1998-07-14 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S002) | Healthtronics Surgical Services, Inc. | 1998-07-14 |
| APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P830045/S057) | St. Jude Medical, Inc. | 1998-07-14 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE (P810002/S047) | ABBOTT MEDICAL | 1998-07-14 |
| ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S009) | Djo, LLC | 1998-07-14 |
| ORTHOPAK II BONE GROWTH STIMULATOR (P850022/S011) | Ahp Eos Buyer, Inc. | 1998-07-14 |
| MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S003) | Medtronic, Inc. | 1998-07-14 |
| DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S002) | Dornier Medtech America, Inc. | 1998-07-10 |
| SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S145) | Scimed Life Systems, Inc. | 1998-07-10 |
| MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL (P970035/S003) | Medtronic, Ireland | 1998-07-10 |
| PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES (P790020/S058) | Advanced Medical Optics, Inc. | 1998-07-09 |
| LL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS (P840031/S009) | Lombart Lenses, Ltd. | 1998-07-09 |
| APLIGRAF (GRAFTSKIN) (P950032/S001) | Organogenesis, Inc. | 1998-07-09 |
| SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) (P960039/S001) | Unilens Corporation, USA | 1998-07-09 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM (P970004/S002) | Medtronic Neuromodulation | 1998-07-08 |
| DORNIER COMPACT DELTA (P840008/S065) | Dornier Medtech America, Inc. | 1998-07-07 |