| PHOENIX 2 AND PARAGON II PACING SYSTEMS (P830045/S051) | St. Jude Medical, Inc. | 1996-10-09 |
| SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS (P880086/S035) | ABBOTT MEDICAL | 1996-10-09 |
| DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE (P840008/S054) | Dornier Medtech America, Inc. | 1996-10-08 |
| WALLSTENT(R) TIPS ENDOPROSTHESIS (P930031/S002) | Boston Scientific Corp | 1996-10-07 |
| IOPTEX PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P860059/S077) | Advanced Medical Optics, Inc. | 1996-10-07 |
| IOPTEX PMMA ANTERIOR CHAMBER IOLS (P880085/S003) | Advanced Medical Optics, Inc. | 1996-10-07 |
| PRECISION(TM) UV (VASURFILCON) (P940013/S005) | Alcon Laboratories, Inc. | 1996-10-07 |
| ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) (N18033/S029) | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996-10-07 |
| THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM (P860003/S025) | Therakos Development Limited | 1996-10-03 |
| REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS (P820018/S070) | St. Jude Medical, Inc. | 1996-10-03 |
| GORE-TEX(TM) SUTURE (P820083/S024) | W. L. Gore & Associates, Inc. | 1996-10-03 |
| GORE-TEX(TM) SUTURE (P820083/S023) | W. L. Gore & Associates, Inc. | 1996-10-03 |
| QUANTITOPE 125I AFP KIT AND CONTROL SERUM (P800025/S005) | Bio-Rad Laboratories, Inc. | 1996-10-02 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |
| H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR (P890023/S006) | The Cooper Companies | 1996-10-02 |
| Angio Seal Vascular Closure Device (P930038) | Terumo Medical Corporation | 1996-09-30 |
| BIORA EMDOGAIN(R) (P930021) | The Straumann Company | 1996-09-30 |
| SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S115) | Scimed Life Systems, Inc. | 1996-09-30 |
| TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L (P880086/S036) | ABBOTT MEDICAL | 1996-09-30 |
| PAPNET (R) TESTING SYSTEM (P940029/S002) | Bd Diagnostics | 1996-09-30 |
| ATAKR(TM) RFCA SYSTEM (P930029/S004) | Medtronic, Inc. | 1996-09-30 |
| META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M (P880038/S033) | St. Jude Medical, Inc. | 1996-09-30 |
| UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS (P920023/S002) | Boston Scientific Corp | 1996-09-27 |
| POLYMACON CONTACT LENSES (P780007/S041) | CooperVision, Inc. | 1996-09-27 |
| PROSORBA(TM) COLUMN (P850020/S008) | Fresenius Hemocare, Inc. | 1996-09-27 |
| BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION (P860023/S010) | Bausch & Lomb, Inc. | 1996-09-27 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL (P900056/S017) | Boston Scientific Corp | 1996-09-27 |
| FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES (P820021/S029) | Alcon Laboratories, Inc. | 1996-09-25 |
| MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS (P870036/S038) | Medtronics Interventional Vascular | 1996-09-25 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S017) | ABBOTT MEDICAL | 1996-09-25 |
| MEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR (P900061/S023) | Medtronic Cardiac Rhythm Disease Management | 1996-09-25 |
| GORE-TEX(R) SUTURE (P820083/S021) | W. L. Gore & Associates, Inc. | 1996-09-24 |
| PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S011) | Alcon Laboratories | 1996-09-24 |
| COMPLETE BRAND LUBRICATING AND REWETTING DROPS (P910075/S009) | Advanced Medical Optics, Inc. | 1996-09-24 |
| ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS (P900067/S002) | Airgas Therapeutics, LLC | 1996-09-24 |
| CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S016) | Alcon Laboratories | 1996-09-24 |
| GORE-TEX SUTURE WITH PLEDGETS (P820083/S022) | W. L. Gore & Associates, Inc. | 1996-09-24 |
| ISPAN TM PERFLUOROPROPANE (C3F8)GAS (P900066/S002) | Airgas Therapeutics, LLC | 1996-09-24 |
| INTEGRA (ARTIFICIAL SKIN) (P900033/S001) | Integra Lifesciences Corp. | 1996-09-23 |
| BAK INTERBODY FUSION SYSTEM (P950002) | Zimmer Spine, Inc. | 1996-09-20 |
| BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD (P830060/S041) | Boston Scientific | 1996-09-20 |
| TRIPTER-X1 NOVA (P920034) | Medirex, Inc. | 1996-09-20 |
| SPINAL-STIM(R) (P850007/S016) | Orthofix, Inc. | 1996-09-19 |
| SPINAL-STIM(R) (P850007/S014) | Orthofix, Inc. | 1996-09-19 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042) | Novadaq Technologies, Inc. | 1996-09-19 |
| MEDTRONIC 9891 BASELINE SOFTWARE/9891 A EPS (P890003/S044) | Medtronic, Inc. | 1996-09-18 |
| FACT(TM) BALLOON CORONARY DILATION CATHETER (P910031/S008) | Abbott Vascular Devices | 1996-09-17 |
| TIER A LENS MODELS UPB360GN AND UP320F (P860059/S076) | Advanced Medical Optics, Inc. | 1996-09-17 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S002) | Intensive Technology, Inc. | 1996-09-17 |
| LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S016) | Leocor, Inc. | 1996-09-17 |
| COOK BIRD'S NEST VENA CAVA FILTER (P850049/S005) | Cook, Inc. | 1996-09-17 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL (P900056/S016) | Boston Scientific Corp | 1996-09-13 |
| COMPLETE BRAND LUBRICATING AND REWETTING DROPS (P910075/S007) | Advanced Medical Optics, Inc. | 1996-09-13 |
| ACS(R) PINKERTON .018(TM) CORONARY DILATION CATHETER (P810046/S163) | Advanced Cardiovascular Systems, Inc. | 1996-09-13 |
| MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S035) | Medtronic, Inc. | 1996-09-10 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S067) | Cochlear Americas | 1996-09-10 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S036) | Cochlear Americas | 1996-09-10 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S020) | ABBOTT MEDICAL | 1996-09-09 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S065) | Cochlear Americas | 1996-09-09 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S034) | Cochlear Americas | 1996-09-09 |
| MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024) | Medtronic, Inc. | 1996-09-06 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S007) | Medtronic, Inc. | 1996-09-06 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007) | Hospira, Inc. | 1996-09-05 |
| COMPLETE BRAND LUBRICATING AND REWETTING DROPS (P910075/S008) | Advanced Medical Optics, Inc. | 1996-09-05 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| FILSHIE CLIP (MARK VI) SYSTEM (P920046) | Femcare , Ltd. | 1996-09-05 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) (P900056/S019) | Boston Scientific Corp | 1996-09-04 |
| MECHANICAL HEART VALVE SJM(R) MASTER SERIES (P810002/S041) | ABBOTT MEDICAL | 1996-09-04 |
| CHUBBY(TM) PTCA CATHETERS (P880027/S040) | Boston Scientific | 1996-09-04 |
| USCI(R) PROCROSS(TM) OVER-THE-WIRE BALLOON DILATION WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING (P790017/S059) | Medtronic, Ireland | 1996-09-03 |
| MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS (P870036/S039) | Medtronics Interventional Vascular | 1996-08-30 |
| SCIMED RANGER PTCA CATHETERS (P860019/S112) | Scimed Life Systems, Inc. | 1996-08-29 |
| HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY (P890064/S004) | Qiagen Gaithersburg, Inc. | 1996-08-28 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S035) | Cochlear Americas | 1996-08-28 |
| GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER (P830063/S001) | Vantive US Healthcare, LLC | 1996-08-28 |
| NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S066) | Cochlear Americas | 1996-08-28 |
| OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES (P890023/S004) | The Cooper Companies | 1996-08-28 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S013) | Corcym S.r.l. | 1996-08-27 |
| SCIMED NC BANDIT PTCA CATHETER (P860019/S114) | Scimed Life Systems, Inc. | 1996-08-27 |
| GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S003) | Gen-Probe, Inc. | 1996-08-22 |
| THINPREP(R) PROCESSOR (P950039/S001) | Hologic, Inc. | 1996-08-22 |
| RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS (P940008/S003) | Boston Scientific | 1996-08-22 |
| EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II (P850035/S020) | Ahp Eos Buyer, Inc. | 1996-08-20 |
| FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS (P910031/S009) | Abbott Vascular Devices | 1996-08-20 |
| RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS (P940008/S002) | Boston Scientific | 1996-08-20 |
| INTERTACH II MODELS 262-16 (P860007/S018) | Boston Scientific | 1996-08-19 |
| MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S022) | Medstone Intl., Inc. | 1996-08-19 |
| MEDTRONIC-HALL PROSTHETIC HEART VALVE (P790018/S027) | Medtronic Cardiac Surgery | 1996-08-19 |
| RELAY/DASH/STRIDE/DART PACING SYSTEMS (P910020/S015) | Boston Scientific | 1996-08-19 |
| ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S019) | Abiomed Cardiovascular, Inc. | 1996-08-19 |
| COSMOS/NOVA/QUANTUM/SUPRIMA/PULSE GENERATORS (P830026/S067) | Boston Scientific | 1996-08-19 |
| RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE (P960020) | Uromed Corp. | 1996-08-16 |
| SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034) | Baxter Healthcare Corporation | 1996-08-12 |
| MEDTRONIC(R) POLYURETHANE STEROID-ELUTING LEAD (P830061/S026) | Medtronic Cardiac Rhythm Disease Management | 1996-08-12 |
| MEDTRONIC SILICONE STEROID-ELUTING LEAD (P850089/S034) | Medtronic Cardiac Rhythm Disease Management | 1996-08-12 |
| MEDTRONIC VDD STEROID-ELUTING LEAD (P890003/S045) | Medtronic, Inc. | 1996-08-12 |
| MEDTRONIC(R) SCREW-IN STEROID ELUTING LEAD (P930039/S001) | Medtronic, Inc. | 1996-08-12 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S011) | Corcym S.r.l. | 1996-08-12 |
| CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT (P880040/S003) | Pierce Biotechnology, Inc. | 1996-08-07 |
| OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010/S001) | Pinnacle Biologics, Inc. | 1996-08-07 |