| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S020) | Abiomed Cardiovascular, Inc. | 1996-12-31 |
| INFUSAID IMPLANTABLE INFUSION PUMP (P800036/S032) | Intera Oncology | 1996-12-30 |
| PROSTATRON (P950014/S003) | Urologix, Inc. | 1996-12-27 |
| STORZ MODULITH LITHOTRIPTER, MODEL SLX (P920051/S005) | KARL STORZ Endoscopy-America, Inc. | 1996-12-27 |
| INFUSAID IMPLANTABLE INFUSION PUMP (P800036/S031) | Intera Oncology | 1996-12-23 |
| HDI 3000 ULTRASOUND SYSTEM (P940005/S001) | Advanced Technology Laboratories, Inc. | 1996-12-23 |
| MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR (P890057/S007) | ZOLL Medical Corporation | 1996-12-20 |
| PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S003) | Cordis Corp. | 1996-12-20 |
| DORNIER COMPACT S TRANSPORTABLE (P840008/S060) | Dornier Medtech America, Inc. | 1996-12-20 |
| VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S071) | Biomerieux Vitek, Inc. | 1996-12-20 |
| META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R) (P900070/S006) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1996-12-20 |
| DORNIER COMPACT S MOBILE (P840008/S059) | Dornier Medtech America, Inc. | 1996-12-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| EDAP LT.02 SHOCK WAVE LITHOTRIPTER (P880042/S002) | Edap International Corp. | 1996-12-18 |
| VASOSEAL (TM) (P920004/S003) | St. Jude Medical, Inc. | 1996-12-18 |
| SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S002) | Baxter Healthcare Corporation | 1996-12-17 |
| SOFLENS66(TM) (P960022) | Bausch & Lomb, Inc. | 1996-12-16 |
| SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S003) | Baxter Healthcare Corporation | 1996-12-16 |
| FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S005) | Gyrus Acmi, Inc. | 1996-12-12 |
| HYDRASOFT METHAFILCON B (P850079/S027) | CooperVision, Inc. | 1996-12-11 |
| VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S006) | Boston Scientific | 1996-12-11 |
| PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID) (P950018/S001) | Alcon Laboratories | 1996-12-11 |
| PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920) (P940007/S002) | Advanced Medical Optics, Inc. | 1996-12-10 |
| HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS (P790007/S013) | Medtronic Heart Valves | 1996-12-10 |
| CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700 (P860057/S003) | Edwards Lifesciences, LLC | 1996-12-06 |
| SENSOLOG(R) CARDIAC PACING SYSTEM (P880006/S022) | St. Jude Medical, Inc. | 1996-12-06 |
| CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL) (P870077/S002) | Edwards Lifesciences, LLC | 1996-12-06 |
| CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL) (P870056/S002) | Edwards Lifesciences, LLC | 1996-12-06 |
| VASOSEAL (TM) (P920004/S004) | St. Jude Medical, Inc. | 1996-12-02 |
| FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS (P910031/S010) | Abbott Vascular Devices | 1996-12-02 |
| ABBOTT AXSYM AFP (LIST 7A48) (P820060/S010) | Abbott Laboratories | 1996-12-02 |
| TEMPO DR 2102 AND TEMP D 2902 (P900070/S015) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1996-11-27 |
| AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST (P940040) | Roche Molecular Systems, Inc. | 1996-11-26 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S005) | Usci, Div. C.R. Bard, Inc. | 1996-11-26 |
| SVS APEX APEX EXIMER LASER WORKSTATION (P930034/S003) | Alcon Laboratories, Inc. | 1996-11-25 |
| PROSTATRON (P950014/S005) | Urologix, Inc. | 1996-11-22 |
| OPTI-ONE(R) MULTI-PURPOSE SOLUTION (P830034/S029) | Alcon Laboratories | 1996-11-21 |
| OPTI-ZYME ENZYMATIC CLEANER (P820001/S019) | Alcon Laboratories | 1996-11-21 |
| BIOTRONIK GEMNOS 04 AND GEMNOS TC O4 (P820076/S018) | Biotronik, Inc. | 1996-11-21 |
| PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES (P790020/S057) | Advanced Medical Optics, Inc. | 1996-11-21 |
| VALOR AND VALOR XL PTCA DILATATION CATHETERS (P880003/S063) | Cordis Corp. | 1996-11-20 |
| PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE (P890003/S048) | Medtronic, Inc. | 1996-11-19 |
| AFP PACING SYSTEM (P830045/S052) | St. Jude Medical, Inc. | 1996-11-19 |
| MEDSTONE STS(TM) LITHOTRIPTER (P870015/S025) | Medstone Intl., Inc. | 1996-11-18 |
| ACS RX COMET(TM) CORONARY DILATION CATHETER (P810046/S166) | Advanced Cardiovascular Systems, Inc. | 1996-11-18 |
| ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM (P890043/S031) | Abbott Vascular | 1996-11-18 |
| PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS (P930012/S004) | Progressive Angioplasty Systems, Inc. | 1996-11-18 |
| ABBOTT IMX SA (P910077/S016) | Boston Scientific | 1996-11-18 |
| EBI ORTHOGEN(R)/OSTEOGEN(TM) IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S038) | Ahp Eos Buyer, Inc. | 1996-11-15 |
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008) | Davis & Geck, Inc. | 1996-11-15 |
| LASERVISION/VISX EXCIMER LASER MODEL C (P960019) | Laser Vision Centers, Inc. | 1996-11-15 |
| EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S019) | Ahp Eos Buyer, Inc. | 1996-11-15 |
| UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S (P880091/S009) | Staar Surgical Co. | 1996-11-14 |
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S011) | Optopics Laboratories Corp. | 1996-11-13 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004) | Boston Scientific | 1996-11-12 |
| SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 (P950001/S001) | Boston Scientific | 1996-11-12 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (P840068/S030) | Boston Scientific | 1996-11-12 |
| VENTAK(R) P MODEL 1600 (P890061/S012) | Boston Scientific | 1996-11-12 |
| BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD (P830060/S042) | Boston Scientific | 1996-11-12 |
| VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD (P910077/S019) | Boston Scientific | 1996-11-12 |
| VIGOR(TM) DR PACEMAKER SYSTEM (P940031/S006) | Boston Scientific | 1996-11-12 |
| VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S007) | Boston Scientific | 1996-11-12 |
| ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S021) | Boston Scientific | 1996-11-12 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S022) | ABBOTT MEDICAL | 1996-11-08 |
| OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION) (P860047/S011) | Bausch & Lomb, Inc. | 1996-11-08 |
| MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM) (P900061/S024) | Medtronic Cardiac Rhythm Disease Management | 1996-11-08 |
| MODEL 2901 PROGRAMMER (P910077/S014) | Boston Scientific | 1996-11-07 |
| SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S001) | Baxter Healthcare Corporation | 1996-11-07 |
| VIGOR MODEL 2880 SOFTWARE APPLICATION (P840068/S029) | Boston Scientific | 1996-11-07 |
| VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S002) | Amo Manufacturing USA, LLC | 1996-11-07 |
| MAXIM PFS MODEL 033-301 (P920011) | St. Jude Medical, Cardiac Rhythm Management Divisi | 1996-11-07 |
| MODEL 2901 PROGRAMMERR SYSTEM (P940031/S005) | Boston Scientific | 1996-11-07 |
| VALOR AND VALOR XL PTCA DILATATION CATHETERS (P880003/S062) | Cordis Corp. | 1996-11-07 |
| THINPREP(R) PROCESSOR (P950039/S005) | Hologic, Inc. | 1996-11-06 |
| DORNIER COMPACT S (P840008/S056) | Dornier Medtech America, Inc. | 1996-11-05 |
| ACS RX STREAK & ACS FLOW TRACK 40 (P810046/S162) | Advanced Cardiovascular Systems, Inc. | 1996-11-05 |
| SYNERGYST II,ELITE & LEGEND PULSE GENERATORS (P890003/S047) | Medtronic, Inc. | 1996-10-30 |
| APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK (P880006/S024) | St. Jude Medical, Inc. | 1996-10-30 |
| MEDTRONIC 9766A/9766AL PROGRAMMING HEAD (P890003/S046) | Medtronic, Inc. | 1996-10-30 |
| RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION (P950019) | Stryker Spine | 1996-10-29 |
| PROSTATRON (P950014/S004) | Urologix, Inc. | 1996-10-29 |
| ACS TX2000TM CORONARY DILATION CATHETER (P810046/S165) | Advanced Cardiovascular Systems, Inc. | 1996-10-25 |
| MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS (P870036/S040) | Medtronics Interventional Vascular | 1996-10-25 |
| MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE (P900061/S027) | Medtronic Cardiac Rhythm Disease Management | 1996-10-22 |
| SVS APEX APEX EXIMER LASER WORKSTATION (P930034/S006) | Alcon Laboratories, Inc. | 1996-10-22 |
| PAPNET (R) TESTING SYSTEM (P940029/S001) | Bd Diagnostics | 1996-10-21 |
| VIGOR(TM) DR PACEMAKER SYSTEM (P940031/S004) | Boston Scientific | 1996-10-18 |
| CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S003) | Edwards Lifesciences, LLC | 1996-10-17 |
| UV-ABSORBING ELASTIMIDE(TM) MODELS AQ-1016VL, AQ-2003VL, AQ-2010VL POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P880091/S008) | Staar Surgical Co. | 1996-10-17 |
| CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP (P870077/S003) | Edwards Lifesciences, LLC | 1996-10-17 |
| ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S045) | Zimmer, Inc. | 1996-10-17 |
| CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS (P860057/S004) | Edwards Lifesciences, LLC | 1996-10-17 |
| MOBILE PROSTATRON (P950014/S002) | Urologix, Inc. | 1996-10-16 |
| MARATHON PACING SYSYTEM (P910020/S016) | Boston Scientific | 1996-10-16 |
| VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S001) | Amo Manufacturing USA, LLC | 1996-10-15 |
| NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S048) | Depuy, Inc. | 1996-10-11 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037) | Biotronik, Inc. | 1996-10-11 |
| NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S051) | Depuy, Inc. | 1996-10-11 |
| NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES (P830055/S049) | Depuy, Inc. | 1996-10-10 |
| NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S050) | Depuy, Inc. | 1996-10-10 |