| CI24R(ST) COCHLEAR IMPLANT (P970051/S010) | Cochlear Americas | 2000-08-21 |
| AFFINITY PULSE GENERATORS (P880086/S075) | ABBOTT MEDICAL | 2000-08-15 |
| LASER SCAN LSX EXCIMER LASER (P980008/S003) | Lasersight Technologies, Inc. | 2000-08-15 |
| THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S003) | Gynecare, Inc. | 2000-08-14 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138) | Biomerieux Vitek, Inc. | 2000-08-11 |
| INTERFIX THREADED FUSION DEVICE (P970015/S014) | Sofamor Danek | 2000-08-09 |
| MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S001) | Medtronic Minimed | 2000-08-09 |
| VENTAK(R) PRIZM(TM) DR/VR HE SYSTEM (P960040/S016) | Boston Scientific | 2000-08-07 |
| VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE (P960040/S015) | Boston Scientific | 2000-08-04 |
| CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S012) | Edwards Lifesciences, LLC | 2000-08-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE (P860057/S014) | Edwards Lifesciences, LLC | 2000-08-04 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S014) | Edwards Lifesciences, LLC | 2000-08-04 |
| VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER (P910001/S018) | Spectranetics Corp. | 2000-08-04 |
| NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEM (P980001/S017) | Boston Scientific Corp | 2000-08-03 |
| CLOSER (TM) SUTURE MEDIATED CLOSURE DEVICE (P960043/S025) | Abbott Vascular, Inc. | 2000-08-03 |
| INFORM HER-2/NEU (P940004/S001) | Ventana Medical Systems, Inc. | 2000-08-01 |
| QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039) | Quidel Corp. | 2000-08-01 |
| ATAKR(R) RFCA ABLATION SYSTEM (P930029/S014) | Medtronic, Inc. | 2000-07-31 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S049) | Boston Scientific Corp | 2000-07-27 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S052) | Boston Scientific Corp | 2000-07-27 |
| VITATRON DIVA PACING SYSTEM (P990001/S003) | Medtronic, Inc. | 2000-07-26 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S036) | Medstone Intl., Inc. | 2000-07-26 |
| D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER (P790017/S072) | Medtronic, Ireland | 2000-07-24 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S051) | Boston Scientific Corp | 2000-07-24 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S050) | Boston Scientific Corp | 2000-07-24 |
| BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES (P900043/S024) | Cordis Corp. | 2000-07-21 |
| ROTABLATOR(R) ROTALINK (P900056/S048) | Boston Scientific Corp | 2000-07-21 |
| STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE (P990071/S001) | Biosense Webster, Inc. | 2000-07-21 |
| 8085 PREVAIL IMPLANTABLE PULSE GENERATOR (P850051/S055) | Medtronic, Inc. | 2000-07-21 |
| SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS (P890003/S060) | Medtronic, Inc. | 2000-07-21 |
| MEDTRONIC ISOMED INFUSION SYSTEM (P990034) | Medtronic, Inc. | 2000-07-21 |
| TCI HEARTMATE 1000A IP LVAS (P920014/S011) | Thoratec Corp | 2000-07-20 |
| NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S026) | LivaNova USA, Inc. | 2000-07-19 |
| ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S025) | Terumo Medical Corporation | 2000-07-17 |
| LITHOSTAR MODULARIS (P870018/S025) | Siemens Corp. | 2000-07-17 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006) | Coloplast Corp. | 2000-07-14 |
| NIR(R) PREMOUNTER STENT SYSTEMS (P980001/S021) | Boston Scientific Corp | 2000-07-14 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064) | Medtronic, Inc. | 2000-07-14 |
| CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE (P940022/S014) | Advanced Bionics Corp. | 2000-07-13 |
| VENTAK PRIZM DR/VR HE AICD (P960040/S014) | Boston Scientific | 2000-07-13 |
| NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEM (P980001/S014) | Boston Scientific Corp | 2000-07-13 |
| SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM (P970043/S008) | Alcon Laboratories | 2000-07-11 |
| PALMAZ BALLOON EXPANDABLE STENT (P890017/S009) | Cordis US Corporation | 2000-07-11 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S047) | Boston Scientific Corp | 2000-07-11 |
| INTER FIX THREADED FUSION DEVICE (P970015/S013) | Sofamor Danek | 2000-07-11 |
| SILIKON 1000 (P950008/S001) | Alcon | 2000-07-11 |
| MENICON Z RIGID GAS PERMEABLE CONTACT LENS (P990018) | Menicon Co, Ltd. | 2000-07-11 |
| PALMZ BALLOON EXPANDABLE STENTS (P890017/S008) | Cordis US Corporation | 2000-07-11 |
| EXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER (P910001/S015) | Spectranetics Corp. | 2000-07-11 |
| NUCLEUS N24 COCHLEAR IMPLANT SYSTEM (P970051/S008) | Cochlear Americas | 2000-07-11 |
| DIAPHRAGMATIC PACEMAKER PHRENIC NERVE (P860026/S006) | Avery Biomedical Devices, Inc. | 2000-07-07 |
| NINJA FX PTCA DILATATION CATHETER (P880003/S080) | Cordis Corp. | 2000-07-07 |
| SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S016) | Baxter Healthcare Corporation | 2000-07-07 |
| OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC (P940010/S008) | Pinnacle Biologics, Inc. | 2000-07-07 |
| VENTRITEX(R) TVL(R) LEAD SYSTEM (P950022/S009) | ABBOTT MEDICAL | 2000-07-06 |
| IMAGE CHECKER M1000 SYSTEM (P970058/S008) | Hologic, Inc. | 2000-07-05 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S006) | Biocontrol Technology, Inc. | 2000-07-05 |
| S660 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S021) | Medtronic, Ireland | 2000-06-30 |
| MASTERS SERIES VALVE: PTFE SEWING CUFF (P810002/S052) | ABBOTT MEDICAL | 2000-06-30 |
| HYPERION LTK SYSTEM (P990078) | Sunrise Technologies, Inc. | 2000-06-30 |
| DIOMED 630 PDT LASER (P990021) | Pinnacle Biologics, Inc. | 2000-06-30 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S020) | Corcym S.r.l. | 2000-06-29 |
| SCIMED PTCA CATHETERS (P860019/S164) | Scimed Life Systems, Inc. | 2000-06-29 |
| ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD (P950001/S007) | Boston Scientific | 2000-06-29 |
| PHILOS PULSE GENERATOR (P950037/S011) | Biotronik, Inc. | 2000-06-28 |
| INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S010) | Medtronic Neuromodulation | 2000-06-28 |
| VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S139) | Biomerieux Vitek, Inc. | 2000-06-26 |
| MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS (P880006/S032) | St. Jude Medical, Inc. | 2000-06-26 |
| MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS (P830045/S070) | St. Jude Medical, Inc. | 2000-06-26 |
| MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS (P880086/S073) | ABBOTT MEDICAL | 2000-06-26 |
| NEUROCONTROL FREEHAND SYSTEM (P950035/S007) | Biocontrol Technology, Inc. | 2000-06-23 |
| SEPRAFILM(TM) BIORESORBABLE MEMBRANE (P950034/S015) | Baxter Healthcare Corporation | 2000-06-23 |
| OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S043) | Ahp Eos Buyer, Inc. | 2000-06-23 |
| HEARTMATE IP & VE LVAS (P920014/S012) | Thoratec Corp | 2000-06-23 |
| SPF SPINAL FUSION STIMULATOR (P850035/S028) | Ahp Eos Buyer, Inc. | 2000-06-23 |
| ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS (P970020/S024) | Abbott Vascular, Inc. | 2000-06-23 |
| SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000 (P900009/S009) | Bioventus, LLC | 2000-06-22 |
| ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM (P900023/S033) | Abiomed Cardiovascular, Inc. | 2000-06-22 |
| PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE (P950037/S012) | Biotronik, Inc. | 2000-06-22 |
| LCS TOTAL KNEE SYSTEM (P830055/S074) | Depuy, Inc. | 2000-06-22 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037) | Vascular Solutions, Inc. | 2000-06-22 |
| VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN (N50510/S137) | Biomerieux Vitek, Inc. | 2000-06-21 |
| VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE (N50510/S135) | Biomerieux Vitek, Inc. | 2000-06-21 |
| VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE (N50510/S136) | Biomerieux Vitek, Inc. | 2000-06-21 |
| APLIGRAF (GRAFTSKIN) (P950032/S016) | Organogenesis, Inc. | 2000-06-20 |
| DISCOVERY/MERIDIAN/PULSAR PACEMAKERS (P940031/S024) | Boston Scientific | 2000-06-20 |
| ACTROS FAMILY OF PULSE GENERATORS (P950037/S014) | Biotronik, Inc. | 2000-06-20 |
| POSTERIOR CHAMBER INTRAOCULAR LENS (P880072/S047) | Eyekon Medical, Inc. | 2000-06-20 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE, MODELS 2700 AND 2800 (P860057/S013) | Edwards Lifesciences, LLC | 2000-06-16 |
| APLIGRAF(R)(GRAFTSKIN) (P950032/S017) | Organogenesis, Inc. | 2000-06-16 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S013) | Advanced Bionics | 2000-06-16 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) (P940022/S015) | Advanced Bionics Corp. | 2000-06-16 |
| CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS, MODELS 6625LP/ESR (P870077/S011) | Edwards Lifesciences, LLC | 2000-06-16 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S013) | Edwards Lifesciences, LLC | 2000-06-16 |
| MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER (P880086/S072) | ABBOTT MEDICAL | 2000-06-15 |
| MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER (P880006/S031) | St. Jude Medical, Inc. | 2000-06-15 |
| PERFLUORON (P950018/S004) | Alcon Laboratories | 2000-06-15 |
| NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025) | Biosense Webster, Inc. | 2000-06-15 |