| SOFTMATE SALINE SOLUTION FOR SENSITIVE EYES (N18078/S049) | Advanced Medical Optics, Inc. | 1995-10-31 |
| MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S037) | Medtronic, Inc. | 1995-10-31 |
| SCIMED NC EXPRESS PLUS HD PTCA CATHETER (P860019/S105) | Scimed Life Systems, Inc. | 1995-10-31 |
| CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S032) | Medtronic Cardiac Rhythm Disease Management | 1995-10-31 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S011) | ABBOTT MEDICAL | 1995-10-31 |
| GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT (P820053/S023) | Advanced Medical Optics, Inc. | 1995-10-31 |
| SOFTMATE SOLUTION (N18073/S024) | Advanced Medical Optics, Inc. | 1995-10-31 |
| SCIMED NC EXPRESS PLUS PTCA CATHETER (P860019/S106) | Scimed Life Systems, Inc. | 1995-10-31 |
| SOFT MATE COMFORT DROPS (P800018/S020) | Advanced Medical Optics, Inc. | 1995-10-31 |
| USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION (P840066/S033) | Advanced Medical Optics, Inc. | 1995-10-31 |
| COLLAGRAFT(TM) BONE GRAFT MATRIX (P900039/S008) | Neucoll, Inc. | 1995-10-30 |
| CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV) (P900060/S007) | Corcym S.r.l. | 1995-10-26 |
| MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065/S002) | Boston Scientific Corp | 1995-10-23 |
| AOSEPT (R) LENS CUP & AODISC NEUTRALIZER (P820040/S032) | Ciba Vision Care | 1995-10-23 |
| SVS APEX EXCIMER LASER SYSTEM (P930034) | Alcon Laboratories, Inc. | 1995-10-20 |
| SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S049) | Boston Scientific Corp | 1995-10-19 |
| SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S050) | Boston Scientific Corp | 1995-10-19 |
| MODELS PC-58NBM & PC-58NBZ IOLS (P820049/S060) | Advanced Medical Optics, Inc. | 1995-10-18 |
| MEDTRONIC INTREL(R) SPINAL CORD STIMULATION SYS. (P840001/S032) | Medtronic Neuromodulation | 1995-10-17 |
| PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST (P900052/S002) | Smiths Medical Asd, Inc. | 1995-10-13 |
| ULTRAZYME(R) ENZYMATIC CLEANER (P860061/S010) | Advanced Medical Optics, Inc. | 1995-10-11 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES MODEL CM22UB (P870045/S039) | Bausch & Lomb, Inc. | 1995-10-11 |
| LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S006) | Medtronic Xomed, Inc. | 1995-10-10 |
| REFLEX MODEL 8223E (P820018/S068) | St. Jude Medical, Inc. | 1995-10-10 |
| DORNIER LITHOTRIPTER TRANSPORTABLE (DLT) (P840008/S052) | Dornier Medtech America, Inc. | 1995-10-05 |
| REALITY FEMALE CONDOM (P910064/S012) | The Female Health Co. | 1995-10-05 |
| POSTERIOR CHAMBER IOL (P840060/S025) | Alcon Laboratories | 1995-10-05 |
| DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (P840008/S051) | Dornier Medtech America, Inc. | 1995-10-05 |
| MODEL 6888 LEAD TUNNELER ACCESSORY (P830060/S040) | Boston Scientific | 1995-10-03 |
| ORACLE(TM) CORONARY BALLOON DILATATION CATHETER (P910031/S002) | Abbott Vascular Devices | 1995-10-03 |
| NC BANDIT PTCA CATHETER (P860019/S104) | Scimed Life Systems, Inc. | 1995-10-02 |
| WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031) | Boston Scientific Corp | 1995-09-29 |
| CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM (P910063) | Matria Healthcare, Inc. | 1995-09-29 |
| VISX MODELB/MODEL C EXCIMER LASER SYSTEM (P910062) | Amo Manufacturing USA, LLC | 1995-09-29 |
| VASOSEAL (TM) (P920004) | St. Jude Medical, Inc. | 1995-09-29 |
| ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS (P930036) | Siemens Healthcare Diagnostics, Inc. | 1995-09-29 |
| AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009) | Bd Diagnostics | 1995-09-29 |
| SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM (P920038) | Matria Healthcare, Inc. | 1995-09-29 |
| CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE (P880082/S018) | Eyetech, LLC | 1995-09-28 |
| OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION (P830034/S027) | Alcon Laboratories | 1995-09-26 |
| MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S010) | Cardiac Control Systems, Inc. | 1995-09-26 |
| IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE (P920006) | Abbott Laboratories | 1995-09-26 |
| CUSTOMEYES(TM) 45L&55L (BUFILCON A) (P850057/S005) | Ciba Vision Corporation | 1995-09-22 |
| HYDROCURVE (BUFILCON A CONTACT LENSES) (N17752/S036) | Ciba Vision Corporation | 1995-09-22 |
| FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK) (P920048) | Hologic, Inc. | 1995-09-21 |
| INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S015) | Intera Oncology | 1995-09-20 |
| ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE (N18020/S040) | Advanced Medical Optics, Inc. | 1995-09-20 |
| SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S009) | Optopics Laboratories Corp. | 1995-09-20 |
| CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S049) | Cordis Corp. | 1995-09-18 |
| IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS (P930027) | Siemens Healthcare Diagnostics, Inc. | 1995-09-15 |
| MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT. (P890057/S003) | ZOLL Medical Corporation | 1995-09-15 |
| MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S021) | Medstone Intl., Inc. | 1995-09-15 |
| AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S014) | Davol Inc., Sub. C. R. Bard, Inc. | 1995-09-14 |
| COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE (P810006/S019) | Integra LifeSciences Corporation | 1995-09-12 |
| HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S015) | Integra LifeSciences Corporation | 1995-09-12 |
| COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS (P840062/S006) | Integra Lifesciences Corp. | 1995-09-08 |
| ADAPETTES (N17945/S028) | Alcon Laboratories | 1995-09-08 |
| VENTAK(R) P3 AICD(TM) SYSTEM (P930035/S001) | Boston Scientific | 1995-09-08 |
| OPTI-CLEAN DAILY CLEANER (P820036/S013) | Alcon Laboratories | 1995-09-08 |
| PREFLEX (N17974/S048) | Alcon Laboratories | 1995-09-08 |
| OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION (P830034/S028) | Alcon Laboratories | 1995-09-08 |
| BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01 (P820076/S017) | Biotronik, Inc. | 1995-09-07 |
| PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S026) | ETHICON, Inc. | 1995-09-07 |
| TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011/S003) | Edap International Corp. | 1995-09-06 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S056) | Cochlear Americas | 1995-08-31 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S026) | Cochlear Americas | 1995-08-31 |
| SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S048) | Boston Scientific Corp | 1995-08-29 |
| MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS (P840001/S037) | Medtronic Neuromodulation | 1995-08-29 |
| MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S001) | Pace Medical | 1995-08-28 |
| MODEL 0010 BIPOLAR ENDOCARDIAL LEAD (P830060/S039) | Boston Scientific | 1995-08-28 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S003) | Molecular Biosystems, Inc. | 1995-08-28 |
| MODIFIED J & C LOOP MODEL PA36 (P880072/S030) | Eyekon Medical, Inc. | 1995-08-24 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S057) | Cochlear Americas | 1995-08-24 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S027) | Cochlear Americas | 1995-08-24 |
| MODIFIED J & C LOOP MODEL PA36 (P880072/S034) | Eyekon Medical, Inc. | 1995-08-24 |
| LEAP EXPRESS PLUSS (P860019/S101) | Scimed Life Systems, Inc. | 1995-08-22 |
| JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S008) | Medtronic Cardiac Rhythm Disease Management | 1995-08-22 |
| JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S012) | Medtronic Cardiac Rhythm Disease Management | 1995-08-22 |
| NUCLEUS 22 CHANNEL COCHLEAR (P840024/S046) | Cochlear Americas | 1995-08-21 |
| DORNIER LITHOTRIPTER (P840008/S050) | Dornier Medtech America, Inc. | 1995-08-21 |
| JEWEL ACTIVE CAN & JEWEL PLUS ACTIVE CAN ARRHYTHMIA MGMT SYSTEMS (P900061/S015) | Medtronic Cardiac Rhythm Disease Management | 1995-08-17 |
| LEAP EXPRESS PLUSS (P860019/S100) | Scimed Life Systems, Inc. | 1995-08-17 |
| SIMPSON CORONARY ATHEROCATH(TM) (P890043/S027) | Abbott Vascular | 1995-08-17 |
| MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS. (P920015/S006) | Medtronic, Inc. | 1995-08-17 |
| HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE (P930030) | Coletica S.A. | 1995-08-15 |
| LEAP EXPRESS PLUSS (P860019/S103) | Scimed Life Systems, Inc. | 1995-08-15 |
| MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S040) | Medtronic, Inc. | 1995-08-15 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S004) | Medtronic, Inc. | 1995-08-14 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S006) | Corcym S.r.l. | 1995-08-14 |
| ROTABLATOR(R) (P900056/S009) | Boston Scientific Corp | 1995-08-14 |
| ENDOTAK(R) LEAD SYSTEM (P910073/S017) | Boston Scientific | 1995-08-14 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S009) | Corcym S.r.l. | 1995-08-14 |
| INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400 (P800036/S030) | Intera Oncology | 1995-08-14 |
| E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S004) | Boston Scientific Corp | 1995-08-14 |
| MEDA-MV PACING SYSTEM (P880038/S030) | St. Jude Medical, Inc. | 1995-08-14 |
| CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S048) | Cordis Corp. | 1995-08-14 |
| E P TECH CARDIAC ABLATION SYSTEM (P920047/S002) | Boston Scientific Corp | 1995-08-14 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES MODEL SP38UB (P870045/S036) | Bausch & Lomb, Inc. | 1995-08-11 |
| MECHANICAL HEART VALVE SJM(R) MASTER SERIES (P810002/S037) | ABBOTT MEDICAL | 1995-08-11 |
| OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S044) | Zimmer, Inc. | 1995-08-11 |