| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| OPTI-FREE(R) SUPRA-CLENS DAILY PROTEIN REMOVER (P820001/S018) | Alcon Laboratories | 1995-12-28 |
| SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS (P810046/S160) | Advanced Cardiovascular Systems, Inc. | 1995-12-28 |
| NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S044) | Depuy, Inc. | 1995-12-28 |
| OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010) | Pinnacle Biologics, Inc. | 1995-12-27 |
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011) | Lumenis, Inc. | 1995-12-27 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012) | American Medical Systems, Inc. | 1995-12-27 |
| AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S013) | Davol Inc., Sub. C. R. Bard, Inc. | 1995-12-27 |
| ABBOTT AXSYM AFP (LIST 7A48) (P820060/S009) | Abbott Laboratories | 1995-12-26 |
| CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500 (P910023/S012) | ABBOTT MEDICAL | 1995-12-22 |
| ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY (P950021) | Siemens Healthcare Diagnostics | 1995-12-22 |
| BIOTRONIK GEMNOS 04, 04A, AND TC 04 (P820076/S020) | Biotronik, Inc. | 1995-12-22 |
| VENTAK MINI AICD SYSTEM (P910077/S008) | Boston Scientific | 1995-12-21 |
| CAPSURE Z MODELS 5034/5534/5033 PACING LEADS (P850089/S033) | Medtronic Cardiac Rhythm Disease Management | 1995-12-21 |
| PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST (P900052/S003) | Smiths Medical Asd, Inc. | 1995-12-21 |
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072) | Thoratec Laboratories Corp. | 1995-12-20 |
| STORZ MODULITH (TM) LITHOTRIPTER (P920051/S001) | KARL STORZ Endoscopy-America, Inc. | 1995-12-19 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER (P850064/S011) | Bunnell, Inc. | 1995-12-18 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003) | Hospira, Inc. | 1995-12-15 |
| GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034) | Gen-Probe, Inc. | 1995-12-15 |
| MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES. (P900061/S020) | Medtronic Cardiac Rhythm Disease Management | 1995-12-14 |
| MODEL C11UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P910058/S007) | Bausch & Lomb, Inc. | 1995-12-14 |
| AOSEPT DISINFECTANT (P820040/S033) | Ciba Vision Care | 1995-12-13 |
| POSTERIOR CHAMBER INTRAOCULAR LENS (P880010/S018) | Alcon Laboratories | 1995-12-13 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001) | Bayer Healthcare, LLC | 1995-12-13 |
| POSTERIOR CHAMBER IOL (P840060/S024) | Alcon Laboratories | 1995-12-13 |
| 3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV (P830040/S025) | Alcon Research, Ltd. | 1995-12-13 |
| NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE (P910016/S005) | Depuy, Inc. | 1995-12-13 |
| UV ABSORBING POSTERIOR CHAMBER IOL (P810018/S035) | Alcon Laboratories | 1995-12-13 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P880087/S006) | Alcon Laboratories | 1995-12-13 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P810001/S012) | Alcon | 1995-12-13 |
| UV ABSORBING POST.CHAM.IOL (P810032/S048) | Alcon Laboratories | 1995-12-13 |
| NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P820021/S025) | Alcon Laboratories, Inc. | 1995-12-13 |
| NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE (P910016/S006) | Depuy, Inc. | 1995-12-13 |
| IRIDOCAPSULAR INTRAOCULAR LENS (P800049/S007) | Alcon | 1995-12-13 |
| NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S042) | Depuy, Inc. | 1995-12-13 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P820035/S014) | Alcon | 1995-12-13 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S059) | Cochlear Americas | 1995-12-11 |
| STORZ MODULITH (TM) LITHOTRIPTER (P920051/S002) | KARL STORZ Endoscopy-America, Inc. | 1995-12-11 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S028) | Cochlear Americas | 1995-12-11 |
| MEDTRONIC TRANSVENE LEAD SYSTEM (P920015/S008) | Medtronic, Inc. | 1995-12-07 |
| SCIMED(R) PTCA CATHETER (P860019/S094) | Scimed Life Systems, Inc. | 1995-12-07 |
| VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 40 (P870036/S037) | Medtronics Interventional Vascular | 1995-12-07 |
| CATHSCANNER ORACLE MICRO PTCA CATHETER (P910031/S003) | Abbott Vascular Devices | 1995-12-07 |
| MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S026) | Medtronic Cardiac Surgery | 1995-12-07 |
| MODEL 7495, ITREL II PERMANENT EXTENSION (P840001/S038) | Medtronic Neuromodulation | 1995-12-06 |
| MEDTRONIC SYNERGYST II PULSE GENERATOR SYSTEM (P890003/S041) | Medtronic, Inc. | 1995-12-06 |
| MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS (P900061/S014) | Medtronic Cardiac Rhythm Disease Management | 1995-12-06 |
| CORDIA PTCA DILATION CATHETERS (P880003/S051) | Cordis Corp. | 1995-12-06 |
| COMPLETE BRAND LUBRICATING AND REWETTING DROPS (P910075/S004) | Advanced Medical Optics, Inc. | 1995-12-05 |
| ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER (P810046/S157) | Advanced Cardiovascular Systems, Inc. | 1995-12-05 |
| CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S050) | Cordis Corp. | 1995-12-05 |
| ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT (P800022/S049) | Allergan | 1995-11-30 |
| INOUE BALLOON CATHETER (P910054/S001) | Toray Industries (America), Inc. | 1995-11-30 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S017) | Abiomed Cardiovascular, Inc. | 1995-11-30 |
| ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P930030/S001) | Coletica S.A. | 1995-11-30 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S018) | Medtronic Cardiac Rhythm Disease Management | 1995-11-29 |
| THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES (P810002/S036) | ABBOTT MEDICAL | 1995-11-28 |
| RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS (P940008) | Boston Scientific | 1995-11-28 |
| ENDOTAK(R) LEAD SYSTEM (P910073/S015) | Boston Scientific | 1995-11-27 |
| AMERICAN EDWARDS LABORATORIES HYBRID PTCA CATHETER, PURSUIT 14 PTCA CATHETER (P850021/S029) | Abbott Vascular, Inc. | 1995-11-27 |
| BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES (P860040/S013) | Wavetouch Technologies, LLC | 1995-11-27 |
| VITEK PIPERACILLIN/TAZOBACTAM (N50510/S064) | Biomerieux Vitek, Inc. | 1995-11-27 |
| DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT (P780002/S012) | Synovis Surgical Innovations | 1995-11-24 |
| SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER (P880027/S036) | Boston Scientific | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S046) | Zimmer, Inc. | 1995-11-20 |
| VENTAK P2 AICD SYSTEM (P930035/S003) | Boston Scientific | 1995-11-20 |
| DELTA PACEMAKER SYSTEM (P840068/S025) | Boston Scientific | 1995-11-20 |
| VENTAK(R) PRX (TM) II AICD SYSTEM (P910077/S007) | Boston Scientific | 1995-11-20 |
| CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS. (N18466/S020) | Depuy, Inc. | 1995-11-20 |
| VENTAK(R) P MODEL 1600 (P890061/S010) | Boston Scientific | 1995-11-20 |
| CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS (N18466/S019) | Depuy, Inc. | 1995-11-20 |
| VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB (P830060/S038) | Boston Scientific | 1995-11-20 |
| SCIMED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS AND TRAPPER EXCHANGE DEVICE (P860019/S102) | Scimed Life Systems, Inc. | 1995-11-20 |
| TCI HEARTMATE(R) 1000A IP LVAD (P920014/S002) | Thoratec Corp | 1995-11-17 |
| REALITY FEMALE CONDOM (P910064/S011) | The Female Health Co. | 1995-11-16 |
| VITEK LOMEFLOXACIN (N50510/S063) | Biomerieux Vitek, Inc. | 1995-11-16 |
| AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM (P830045/S050) | St. Jude Medical, Inc. | 1995-11-13 |
| AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM (P880086/S034) | ABBOTT MEDICAL | 1995-11-13 |
| AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM (P880006/S023) | St. Jude Medical, Inc. | 1995-11-13 |
| PAPNET (R) TESTING SYSTEM (P940029) | Bd Diagnostics | 1995-11-08 |
| EPT-1000 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL (P920047/S001) | Boston Scientific Corp | 1995-11-08 |
| ACS SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETER (P810046/S156) | Advanced Cardiovascular Systems, Inc. | 1995-11-07 |
| MODEL 9881E SOFTWARE (9881E 217214 REVISION:C) (P900061/S019) | Medtronic Cardiac Rhythm Disease Management | 1995-11-06 |
| NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S041) | Depuy, Inc. | 1995-11-06 |
| TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY (P850048/S011) | Beckman Coulter, Inc. | 1995-11-06 |
| PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S025) | ETHICON, Inc. | 1995-11-02 |
| MODIFIED J & C LOOP MODEL PA36 POSTERIOR CHAMBER INTRAOCULAR LENS (P880072/S037) | Eyekon Medical, Inc. | 1995-11-01 |
| TRILOGY PULSE GENERATOR MODELS 235OL, 2250L, AND 2308L (P880086/S033) | ABBOTT MEDICAL | 1995-11-01 |
| SYNCHRONY III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS (P880086/S032) | ABBOTT MEDICAL | 1995-11-01 |
| NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S040) | Depuy, Inc. | 1995-11-01 |
| OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION (P830034/S026) | Alcon Laboratories | 1995-10-31 |
| MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S051) | Medtronic, Inc. | 1995-10-31 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S008) | ABBOTT MEDICAL | 1995-10-31 |
| CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S022) | Cordis Corp. | 1995-10-31 |
| MEDTRONIC MODEL 5348 TEMPORARY PACEMAKERS (P820003/S070) | Medtronic Cardiac Rhythm Disease Management | 1995-10-31 |
| SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE (P890003/S042) | Medtronic, Inc. | 1995-10-31 |
| SCIMED LEAP EXPRESS PLUS (P860019/S107) | Scimed Life Systems, Inc. | 1995-10-31 |
| MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD (P830061/S025) | Medtronic Cardiac Rhythm Disease Management | 1995-10-31 |