| RX5000 (TM) GRAPHICS PROGRAMMER (P830026/S069) | Boston Scientific | 1997-04-28 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S004) | Terumo Medical Corporation | 1997-04-25 |
| ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S002) | Terumo Medical Corporation | 1997-04-25 |
| MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM (P840001/S040) | Medtronic Neuromodulation | 1997-04-25 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S005) | Boston Scientific | 1997-04-25 |
| VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S003) | Amo Manufacturing USA, LLC | 1997-04-24 |
| REFRESH CL(TM)/LUBRICATING AND REWETING DROPS (P960012/S001) | Abbott Medical Optics, Inc. | 1997-04-24 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S077) | Biomerieux Vitek, Inc. | 1997-04-24 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S075) | Biomerieux Vitek, Inc. | 1997-04-24 |
| SCIMED(R)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S118) | Scimed Life Systems, Inc. | 1997-04-24 |
| TVL(TM) LEAD SYSTEM (P950022/S001) | ABBOTT MEDICAL | 1997-04-23 |
| EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S022) | Ahp Eos Buyer, Inc. | 1997-04-22 |
| ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S004) | Alcon Laboratories, Inc. | 1997-04-22 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P880087/S009) | Alcon Laboratories | 1997-04-22 |
| ELIPSE 14,000.014 CORONARY DILATATION CATHETER (P810046/S168) | Advanced Cardiovascular Systems, Inc. | 1997-04-21 |
| TX-2000 (P810046/S173) | Advanced Cardiovascular Systems, Inc. | 1997-04-21 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S003) | Thoratec Laboratories Corp. | 1997-04-17 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S023) | ABBOTT MEDICAL | 1997-04-17 |
| RX5000 (TM) GRAPHICS PROGRAMMER (P830026/S070) | Boston Scientific | 1997-04-17 |
| PROSORBA(TM) COLUMN (P850020/S009) | Fresenius Hemocare, Inc. | 1997-04-17 |
| SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) (P960039) | Unilens Corporation, USA | 1997-04-17 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S021) | Abiomed Cardiovascular, Inc. | 1997-04-16 |
| PHYSIO-STIM LITE BONE GROWTH STIMULATOR (P850007/S018) | Orthofix, Inc. | 1997-04-16 |
| VASOSEAL (TM) (P920004/S006) | St. Jude Medical, Inc. | 1997-04-15 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S004) | Boston Scientific Corp | 1997-04-15 |
| TC65B-SUV (P880072/S044) | Eyekon Medical, Inc. | 1997-04-15 |
| WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019/S002) | Boston Scientific Scimed, Inc. | 1997-04-14 |
| RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION (P950019/S001) | Stryker Spine | 1997-04-11 |
| UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS (P920023/S001) | Boston Scientific Corp | 1997-04-11 |
| SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER (P860019/S113) | Scimed Life Systems, Inc. | 1997-04-09 |
| AMO(R) VITRAX(R) VISCOELASTIC SOLUTION (P880031/S011) | Abbott Medical Optics, Inc. | 1997-04-09 |
| FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS (P910031/S011) | Abbott Vascular Devices | 1997-04-09 |
| THINPREP(R) PROCESSOR (P950039/S003) | Hologic, Inc. | 1997-04-08 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S028) | Medtronic Cardiac Surgery | 1997-04-07 |
| ECONOLITH(TM) LITHOTRIPTER (P950043) | Medispec, Ltd. | 1997-04-07 |
| MOBILEXCIMER FOR PTK AND PRK (P960019/S001) | Laser Vision Centers, Inc. | 1997-04-07 |
| ACS TX2000 VP CORONARY DILITATION CATHETER (P810046/S172) | Advanced Cardiovascular Systems, Inc. | 1997-04-07 |
| OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010/S003) | Pinnacle Biologics, Inc. | 1997-04-04 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S068) | Cochlear Americas | 1997-04-04 |
| UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S (P880091/S007) | Staar Surgical Co. | 1997-04-04 |
| ENDURANCE BONE CEMENT (P960001/S002) | Depuy, Inc. | 1997-04-03 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S037) | Cochlear Americas | 1997-04-01 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S076) | Biomerieux Vitek, Inc. | 1997-03-27 |
| SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000 (P900009/S003) | Bioventus, LLC | 1997-03-27 |
| MEDTRONIC MODEL 5388 TEMPORARY PACEMAKER (P820003/S072) | Medtronic Cardiac Rhythm Disease Management | 1997-03-27 |
| ABBOTT IMX(R) HAVAB(R)-M (P790019/S008) | Abbott Laboratories | 1997-03-27 |
| STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION) (P920051/S006) | KARL STORZ Endoscopy-America, Inc. | 1997-03-27 |
| OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE (P830039/S006) | Medical Cv, Inc. | 1997-03-26 |
| ENUCLENE CLEANING/LUBRICATING SOLUTION (N13787) | Alcon Research, Ltd. | 1997-03-26 |
| TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS (P920034/S001) | Medirex, Inc. | 1997-03-26 |
| OPTI-FREE REWETTING DROPS (P830034/S031) | Alcon Laboratories | 1997-03-26 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0) (P840068/S031) | Boston Scientific | 1997-03-25 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0) (P940031/S008) | Boston Scientific | 1997-03-25 |
| UVAR PHOTOPHORESIS SYSTEM (P860003/S028) | Therakos Development Limited | 1997-03-25 |
| 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL (P880081/S022) | Johnson & Johnson Surgical Vision, Inc. | 1997-03-24 |
| FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S006) | Gyrus Acmi, Inc. | 1997-03-21 |
| NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) (P940002) | Sulzermedica | 1997-03-21 |
| OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION (P830034/S033) | Alcon Laboratories | 1997-03-19 |
| OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392 (P830071/S009) | Alcon Laboratories | 1997-03-19 |
| MATRITECH NMP22(TM) TEST KIT (P940035/S001) | Abbott Diagnostics Scarborough, Inc. | 1997-03-19 |
| TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007) | Shire Regenerative Medicine | 1997-03-18 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S074) | Biomerieux Vitek, Inc. | 1997-03-17 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S029) | Medtronic Cardiac Surgery | 1997-03-17 |
| TC65B-SUV (P880072/S045) | Eyekon Medical, Inc. | 1997-03-13 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S005) | Cordis Corp. | 1997-03-13 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S031) | Medtronic Cardiac Rhythm Disease Management | 1997-03-13 |
| SVS APEX APEX EXIMER LASER WORKSTATION (P930034/S007) | Alcon Laboratories, Inc. | 1997-03-12 |
| TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK (P880086/S039) | ABBOTT MEDICAL | 1997-03-12 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S006) | Boston Scientific Corp | 1997-03-12 |
| SVS APEX PLUS EXCIMER LASER WORKSTATION (P910067/S002) | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 1997-03-12 |
| CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER (P950029) | MicroPort CRM USA, Inc. | 1997-03-10 |
| SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION (P820031/S014) | Bausch & Lomb, Inc. | 1997-03-10 |
| SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN (P850077/S022) | CooperVision, Inc. | 1997-03-10 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S029) | Medtronic Cardiac Rhythm Disease Management | 1997-03-07 |
| CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) (P900060/S012) | Corcym S.r.l. | 1997-03-07 |
| REALITY FEMALE CONDOM (P910064/S013) | The Female Health Co. | 1997-03-07 |
| MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS (P850089/S035) | Medtronic Cardiac Rhythm Disease Management | 1997-03-07 |
| MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS (P870036/S041) | Medtronics Interventional Vascular | 1997-03-07 |
| NEEDLE-EASE TM 2501 (P960044) | Millenium Medical Supply, Inc. | 1997-03-06 |
| MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S030) | Medtronic Cardiac Rhythm Disease Management | 1997-03-06 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S015) | ABBOTT MEDICAL | 1997-03-03 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S025) | ABBOTT MEDICAL | 1997-03-03 |
| USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL (P790017/S061) | Medtronic, Ireland | 1997-03-03 |
| ITREL II SPINAL CORD STIMULATION SYSTE, INCLUDING A BIFURCATED Y-EXTENSION (P840001/S039) | Medtronic Neuromodulation | 1997-02-28 |
| RES-Q(TM) MICRON ICD SYSTEM (P940008/S004) | Boston Scientific | 1997-02-28 |
| ARC(TM) BALLOON CORONARY DILATATION CATHETERS (P910031/S012) | Abbott Vascular Devices | 1997-02-27 |
| ABBOTT ANTI-DELTA EIA (P850062/S002) | Abbott Laboratories | 1997-02-26 |
| DR. BROWN'S HOME DRUG TESTING KIT (P950040/S001) | Personal Health & Hygiene, Inc. | 1997-02-26 |
| THINPREP(R) 2000 SYSTEM (P950039/S002) | Hologic, Inc. | 1997-02-25 |
| ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS (P880027/S043) | Boston Scientific | 1997-02-19 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S073) | Biomerieux Vitek, Inc. | 1997-02-19 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S072) | Biomerieux Vitek, Inc. | 1997-02-19 |
| GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS (P880027/S044) | Boston Scientific | 1997-02-19 |
| VIGOR(R) DR/SR PACEMAKER SYSTEM (P940031/S009) | Boston Scientific | 1997-02-18 |
| DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S032) | Boston Scientific | 1997-02-18 |
| VENTAK PRX AICD SYSTEM (P910077/S020) | Boston Scientific | 1997-02-18 |
| COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION (P820053/S025) | Advanced Medical Optics, Inc. | 1997-02-13 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) (P900056/S018) | Boston Scientific Corp | 1997-02-13 |
| SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM (P880062/S002) | Labthermics Technologies, Inc. | 1997-02-13 |
| DEPUY 1 BONE CEMENT (P960001) | Depuy, Inc. | 1997-02-11 |