| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S004) | Intensive Technology, Inc. | 1998-12-30 |
| OMNISCIENCE CARDIAC VALVE PROSTHESIS (P830039/S009) | Medical Cv, Inc. | 1998-12-30 |
| MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S012) | Medtronic, Ireland | 1998-12-29 |
| PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER (P810046/S187) | Advanced Cardiovascular Systems, Inc. | 1998-12-28 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (P790027/S061) | Bausch & Lomb | 1998-12-28 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (P870045/S040) | Bausch & Lomb, Inc. | 1998-12-28 |
| SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P910061/S005) | Bausch & Lomb | 1998-12-28 |
| ANTERIOR CHAMBER INTRAOCULAR LENSES (P870013/S010) | Bausch & Lomb | 1998-12-28 |
| ANTERIOR CHAMBER INTRAOCULAR LENSES (P850059/S018) | Bausch & Lomb Surgical, Inc. | 1998-12-28 |
| FLEX TIP INTRASPINAL KIT, CATALOG AP-07008 (P890055/S005) | Intera Oncology | 1998-12-23 |
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011/S002) | Lumenis, Inc. | 1998-12-23 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S002) | American Medical Systems, Inc. | 1998-12-23 |
| OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010/S004) | Pinnacle Biologics, Inc. | 1998-12-23 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |
| CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER (P950029/S001) | MicroPort CRM USA, Inc. | 1998-12-22 |
| ACS RX GEMINI CORONARY DILATATION CATHETER (P810046/S193) | Advanced Cardiovascular Systems, Inc. | 1998-12-22 |
| TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S010) | Abbott Vascular, Inc. | 1998-12-21 |
| PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S014) | Abbott Vascular, Inc. | 1998-12-21 |
| GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER (P850049/S006) | Cook, Inc. | 1998-12-21 |
| NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S013) | LivaNova USA, Inc. | 1998-12-18 |
| NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S012) | LivaNova USA, Inc. | 1998-12-18 |
| EC-5000 EXCIMER LASER SYSTEM (P970053) | Nidek Co., Ltd. | 1998-12-17 |
| BAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS (P910061/S006) | Bausch & Lomb | 1998-12-14 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S001) | Innovative Medical Systems, Inc. | 1998-12-14 |
| TRIPTER-X1 (P920034/S003) | Medirex, Inc. | 1998-12-14 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024) | Abbott Molecular, Inc. | 1998-12-11 |
| VASOSEAL ES DEVICE (P920004/S008) | St. Jude Medical, Inc. | 1998-12-11 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S015) | Terumo Medical Corporation | 1998-12-11 |
| THE ORACLE MEGASONICS FIVE-64 PTCA CATHER (P910031/S019) | Abbott Vascular Devices | 1998-12-11 |
| NINJA PTCA DILATION CATHETERS (P880003/S075) | Cordis Corp. | 1998-12-11 |
| TVL LEAD SYSTEM (P950022/S004) | ABBOTT MEDICAL | 1998-12-09 |
| CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S037) | ABBOTT MEDICAL | 1998-12-09 |
| VENTAK AV II/III DR AICD SYSTEMS (P960040/S008) | Boston Scientific | 1998-12-08 |
| SWEET TIP (P830060/S044) | Boston Scientific | 1998-12-08 |
| VENTAK AV AICD FAMILY SYSTEMS (P960040/S007) | Boston Scientific | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030) | Bayer Healthcare, LLC | 1998-12-08 |
| TECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S013) | Abbott Vascular, Inc. | 1998-12-07 |
| COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S010) | Neucoll, Inc. | 1998-12-07 |
| PERMLENS (P780010/S020) | CooperVision, Inc. | 1998-12-04 |
| MEDTRONIC SYNCHROMED PUMP HYBRID (P860004/S041) | Medtronic, Inc. | 1998-12-04 |
| VENTAK MINI ACID FAMILY SYSTEMS (P910077/S025) | Boston Scientific | 1998-12-02 |
| AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST (P940034/S009) | Gen-Probe, Inc. | 1998-12-01 |
| TRANSCYTE (DERMAGRAFT-TC) (P960007/S009) | Shire Regenerative Medicine | 1998-12-01 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S005) | Boston Scientific Corp | 1998-11-30 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002) | Wrightmedicaltechnologyinc | 1998-11-25 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S014) | Terumo Medical Corporation | 1998-11-25 |
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011/S003) | Lumenis, Inc. | 1998-11-24 |
| ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM (P970020/S003) | Abbott Vascular, Inc. | 1998-11-24 |
| MEDTRONIC SPRINT MODELS 6943/6945 (P920015/S015) | Medtronic, Inc. | 1998-11-23 |
| OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC (P940010/S005) | Pinnacle Biologics, Inc. | 1998-11-23 |
| UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S001) | Aaren Scientific | 1998-11-20 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S076) | Cochlear Americas | 1998-11-19 |
| MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S002) | Medtronic, Inc. | 1998-11-19 |
| KAIROS (P950037/S005) | Biotronik, Inc. | 1998-11-19 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S003) | Cochlear Americas | 1998-11-19 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S045) | Cochlear Americas | 1998-11-19 |
| CHORUS PACEMAKERS (P900022/S005) | MicroPort CRM USA, Inc. | 1998-11-18 |
| OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS (P950029/S003) | MicroPort CRM USA, Inc. | 1998-11-18 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S003) | Healthtronics Surgical Services, Inc. | 1998-11-18 |
| SWEET TIP RX MODELS 4143/4144/4145/4243/4244/4245 ACTIVE-FIXATION, STEROID ELUTING, ENDOCARDIAL PACING LEADS (P960006/S002) | Boston Scientific | 1998-11-17 |
| MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S009) | Medtronic, Ireland | 1998-11-17 |
| GFX OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S010) | Medtronic, Ireland | 1998-11-17 |
| THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER (P870036/S044) | Medtronics Interventional Vascular | 1998-11-17 |
| THE NEEDLE DESTROYER (P960018/S001) | Healthcare Products Plus, Inc. | 1998-11-17 |
| LITHO TRON LITHOTRIPSY SYSTEM (P970019/S005) | Healthtronics Surgical Services, Inc. | 1998-11-17 |
| CHARGER PTCA DILATION CATHETERS (P880003/S077) | Cordis Corp. | 1998-11-16 |
| MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S034) | Medtronic Cardiac Surgery | 1998-11-16 |
| ACS MULTI-LINK CORONARY STENT SYSTEMS (P970020/S006) | Abbott Vascular, Inc. | 1998-11-10 |
| POLY-SAFE(TM) A-TRACK(TM) PACING LEADS (P890039/S016) | Cardiac Control Systems, Inc. | 1998-11-09 |
| SYNVISC (HYLAN G-F 20 (P940015/S001) | Sanofi Genzyme Corp. | 1998-11-05 |
| ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS (P970020/S004) | Abbott Vascular, Inc. | 1998-11-05 |
| UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC (P880091/S014) | Staar Surgical Co. | 1998-11-04 |
| BIPOLAR ENDOCARDIAL LEAD (P830060/S043) | Boston Scientific | 1998-11-04 |
| DROMOS S.L. PACING SYSTEM (P820076/S021) | Biotronik, Inc. | 1998-11-04 |
| CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM (P910023/S036) | ABBOTT MEDICAL | 1998-11-04 |
| SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM (P850007/S024) | Orthofix, Inc. | 1998-11-03 |
| TRILOGY FAMILY OF PULSE GENERATORS (P880086/S056) | ABBOTT MEDICAL | 1998-11-03 |
| MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM (P970004/S003) | Medtronic Neuromodulation | 1998-11-02 |
| LADARVISION EXCIMER LASER SYSTEM (P970043) | Alcon Laboratories | 1998-11-02 |
| AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES (N970012) | Boston Scientific Corp | 1998-11-02 |
| VISX STAR S2 EXCIMER LASER SYSTEM (P930016/S007) | Amo Manufacturing USA, LLC | 1998-11-02 |
| HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE (P790007/S015) | Medtronic Heart Valves | 1998-10-30 |
| MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS (P970031/S007) | Medtronic, Inc. | 1998-10-30 |
| RAY TFC DEVICE INSTRUMENTATION (P950019/S005) | Stryker Spine | 1998-10-29 |
| RECTAL THERMOSENSING UNIT RTU (P970008/S009) | Urologix, LLC | 1998-10-29 |
| TEMPO FAMILY OF PULSE GENERATORS (P900070/S024) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1998-10-29 |
| CAPSURE SP NOVUS (P850089/S040) | Medtronic Cardiac Rhythm Disease Management | 1998-10-29 |
| PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023) | Biotronik, Inc. | 1998-10-27 |
| PERMAFLEX NATURALS (P790020/S059) | Advanced Medical Optics, Inc. | 1998-10-27 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S010) | Edwards Lifesciences, LLC | 1998-10-26 |
| MODEL 6998 IS-1 LEAD PORT PLUG (P910077/S024) | Boston Scientific | 1998-10-26 |
| CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR (P870077/S008) | Edwards Lifesciences, LLC | 1998-10-26 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE MODELS 2700 AND 2800 (P860057/S009) | Edwards Lifesciences, LLC | 1998-10-26 |
| SPL TRIPOLAR, TINED TRANSVENOUS DEFIBRILLATION LEADS (P950022/S003) | ABBOTT MEDICAL | 1998-10-22 |
| CONTOUR(R) II/ANGSTROM(TM) II ICD SYSTEMS (P910023/S034) | ABBOTT MEDICAL | 1998-10-22 |
| ORTHOSET BONE CEMENT (N18466/S023) | Depuy, Inc. | 1998-10-21 |
| IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE (P970058/S001) | Hologic, Inc. | 1998-10-21 |
| APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04) (P880086/S053) | ABBOTT MEDICAL | 1998-10-21 |
| APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04) (P830045/S061) | St. Jude Medical, Inc. | 1998-10-21 |