| VISX STAR S2 AND S3 EXCIMER LASER SYSTEM (P930016/S010) | Amo Manufacturing USA, LLC | 2000-10-18 |
| KNOT PUSHER WITH TRIMMER(TM) (P960043/S027) | Abbott Vascular, Inc. | 2000-10-17 |
| GELFOAM STERILE POWDER (N18286/S012) | Pfizer, Inc. | 2000-10-16 |
| ANCURE ENDOGRAFT SYSTEM (P990017/S008) | Boston Scientific Corp | 2000-10-16 |
| BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022) | Medtronic Vascular | 2000-10-16 |
| ACTROS SLR PULSE GENERATOR (P950037/S013) | Biotronik, Inc. | 2000-10-13 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046) | Medtronic Ats Medical, Inc. | 2000-10-13 |
| NIR PREMOUNTED STENT SYSTEMS (P980001/S025) | Boston Scientific Corp | 2000-10-12 |
| HEALTHTRONICS OSSATRON (P990086) | Sanuwave, Inc. | 2000-10-12 |
| ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S036) | Boston Scientific | 2000-10-12 |
| ELA RATE-RESPONSIVE PACEMAKERS (P950029/S011) | MicroPort CRM USA, Inc. | 2000-10-11 |
| MEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM (P980035/S008) | Medtronic, Inc. | 2000-10-10 |
| TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR) (P950029/S010) | MicroPort CRM USA, Inc. | 2000-10-10 |
| BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE (P860019/S162) | Scimed Life Systems, Inc. | 2000-10-05 |
| ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S055) | Boston Scientific Corp | 2000-10-05 |
| ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S032) | Boston Scientific | 2000-10-05 |
| LEAD CAP ACCESSORY KIT (P940008/S015) | Boston Scientific | 2000-10-05 |
| MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM (P970020/S023) | Abbott Vascular, Inc. | 2000-10-03 |
| INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL (P830045/S072) | St. Jude Medical, Inc. | 2000-10-02 |
| INTEGRITY AFX DR/INTEGRITY SR (P880086/S078) | ABBOTT MEDICAL | 2000-10-02 |
| MEDTRONIC 9790/9790C PROGRAMMER (P890003/S061) | Medtronic, Inc. | 2000-10-02 |
| CLOSER S(TM) 6FR. SMC DEVICE (P960043/S026) | Abbott Vascular, Inc. | 2000-09-29 |
| PHYLAX AV ICD SYSTEM (P000009) | Biotronik, Inc. | 2000-09-29 |
| BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM (P000011) | Abbott Vascular, Inc. | 2000-09-29 |
| OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM (P940010/S009) | Pinnacle Biologics, Inc. | 2000-09-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS (P000014) | Ortho-Clinical Diagnostics, Inc. | 2000-09-29 |
| CORDIS WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S009) | Biosense Webster, Inc. | 2000-09-29 |
| NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S001) | Biosense Webster, Inc. | 2000-09-28 |
| LORDOTEC(TM) TAPERED FUSION DEVICE (P970015/S010) | Sofamor Danek | 2000-09-28 |
| THE HEART LASER(TM)CO2 TMR SYSTEM (P950015/S007) | Laser Engineering Heart, Inc. | 2000-09-27 |
| ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011) | Wrightmedicaltechnologyinc | 2000-09-27 |
| SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER (P860019/S160) | Scimed Life Systems, Inc. | 2000-09-27 |
| SPF IMPLANTABLE BONE GROWTH STIMULATOR (P850035/S025) | Ahp Eos Buyer, Inc. | 2000-09-27 |
| BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR (P990019/S001) | Sun Pharmaceutical Industries, Inc. | 2000-09-26 |
| COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P990013/S001) | Starr Surgical Co. | 2000-09-25 |
| IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER (P910073/S034) | Boston Scientific | 2000-09-25 |
| VENTAK P MODEL 16OO (P890061/S013) | Boston Scientific | 2000-09-25 |
| TVL LEAD SYSTEM (P950022/S011) | ABBOTT MEDICAL | 2000-09-25 |
| ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES (P910077/S033) | Boston Scientific | 2000-09-25 |
| THINLINE II/FINELINE II (P960004/S015) | Boston Scientific | 2000-09-25 |
| SWEET TIP RX STEROID ELUTING LEAD (P960006/S004) | Boston Scientific | 2000-09-25 |
| METHAFILCON A (P850079/S037) | CooperVision, Inc. | 2000-09-25 |
| MEMORY LENS(R) UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL (P960036/S003) | Ioltech, S.A. | 2000-09-25 |
| ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD (P950001/S008) | Boston Scientific | 2000-09-25 |
| TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM (P990040) | Cerenovus, Inc. | 2000-09-25 |
| MODEL 6577 STERILIZABLE TELEMETRY WAND (P830060/S049) | Boston Scientific | 2000-09-25 |
| LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA) (P970043/S007) | Alcon Laboratories | 2000-09-22 |
| VIBRANT P SOUNDBRIDGE/VIBRANT D SOUNDBRIDGE SYSTEM (P990052/S001) | Med-El Elektromedizinische Gerate GmbH | 2000-09-21 |
| NC NINJA PTCA DILATATION CATHETER (P880003/S081) | Cordis Corp. | 2000-09-21 |
| DTU-ONE ULTRASOUND SCANNER (P980010) | Osteometer Meditech A/S | 2000-09-19 |
| SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A) (N17752/S037) | Ciba Vision Corporation | 2000-09-18 |
| CSI(CROFILCON A)EXTENDED WEAR SOFT (N17987/S028) | Ciba Vision Corporation | 2000-09-18 |
| ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S054) | Boston Scientific Corp | 2000-09-18 |
| CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A) (P850057/S006) | Ciba Vision Corporation | 2000-09-18 |
| ELA RATE-RESPONSIVE PACEMAKERS (P950029/S012) | MicroPort CRM USA, Inc. | 2000-09-13 |
| SYNVISC (HYLAN G-F 20) (P940015/S005) | Sanofi Genzyme Corp. | 2000-09-12 |
| IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER (P910073/S033) | Boston Scientific | 2000-09-12 |
| ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S001) | Roche Molecular Systems, Inc. | 2000-09-12 |
| HCS HPV, HCII HPV (P890064/S008) | Qiagen Gaithersburg, Inc. | 2000-09-12 |
| GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES (P890012/S004) | Ciba Vision Corporation | 2000-09-12 |
| BAYER IMMUNO 1 COMPLEXED PSA ASSAY (P990055) | Siemens Healthcare Diagnostics | 2000-09-08 |
| MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM (P970020/S021) | Abbott Vascular, Inc. | 2000-09-08 |
| LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S005) | Depuy Spine, Inc. | 2000-09-08 |
| EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S011) | Bioventus, LLC | 2000-09-08 |
| V.1 2A PROGRAMMER SOFTWARE (P880006/S033) | St. Jude Medical, Inc. | 2000-09-07 |
| TRILOGY/SOLUS II/PARAGON III/PHOENIX III (P900070/S027) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2000-09-07 |
| CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S048) | ABBOTT MEDICAL | 2000-09-07 |
| TENDRILL PASSIVE PLUS/AU PLUS DX (P960030/S007) | ABBOTT MEDICAL | 2000-09-07 |
| AV PLUS DX (P880086/S077) | ABBOTT MEDICAL | 2000-09-07 |
| TENDRIL SDX (P960013/S008) | ABBOTT MEDICAL | 2000-09-07 |
| V1. 2A PROGRAMMER SOFTWARE (P830045/S071) | St. Jude Medical, Inc. | 2000-09-07 |
| VENTRITEX TUL LEAD SYSTEM (P950022/S010) | ABBOTT MEDICAL | 2000-09-07 |
| MENICON SF-P (TM) (P880098/S011) | Menicon Co, Ltd. | 2000-09-06 |
| MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P990018/S001) | Menicon Co, Ltd. | 2000-09-06 |
| CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS (P900060/S021) | Corcym S.r.l. | 2000-09-05 |
| PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY (P900066/S004) | Airgas Therapeutics, LLC | 2000-09-05 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S006) | Advanced Bionics | 2000-09-05 |
| MEDSTONE STS LITHOTRIPTER (P970042) | Medstone Intl., Inc. | 2000-09-05 |
| PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE. (P950037/S015) | Biotronik, Inc. | 2000-09-05 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S006) | Aaren Scientific | 2000-08-31 |
| CAPSUREFIX(R) (P930039/S009) | Medtronic, Inc. | 2000-08-31 |
| VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM (P990052) | Med-El Elektromedizinische Gerate GmbH | 2000-08-31 |
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| APLIGRAF(R) (P950032/S018) | Organogenesis, Inc. | 2000-08-31 |
| HYALGAN (P950027/S004) | Fidia Farmaceutici S.P.A. | 2000-08-30 |
| AUTOCYTE PREP SYSTEM (P970018/S001) | Bd Diagnostic Systems | 2000-08-29 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S002) | Medtronic, Inc. | 2000-08-29 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S001) | Medtronic, Inc. | 2000-08-29 |
| LADARVISION EXCIMER LASER SYSTEM (P970043/S009) | Alcon Laboratories | 2000-08-28 |
| CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS (P860057/S011) | Edwards Lifesciences, LLC | 2000-08-28 |
| R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER (P790017/S071) | Medtronic, Ireland | 2000-08-28 |
| MEMORY LENS MODEL U940A UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL (P960036/S001) | Ioltech, S.A. | 2000-08-25 |
| AV PLUS DX MODEL 1368 LEAD (P880086/S076) | ABBOTT MEDICAL | 2000-08-25 |
| MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL (P960036/S002) | Ioltech, S.A. | 2000-08-25 |
| NEUROCYBERNETIC PROSTHESIS(NCP(R)) SYSTEM (P970003/S027) | LivaNova USA, Inc. | 2000-08-24 |
| SPINALOGIC BONE GROWTH STIMULATOR (P910066/S015) | Djo, LLC | 2000-08-23 |
| W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES (P990072) | Westcon Contact Lens Co., Inc. | 2000-08-22 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S053) | Boston Scientific Corp | 2000-08-22 |
| BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT (P970061/S009) | Boston Scientific Scimed, Inc. | 2000-08-22 |
| LIPOSORBER(R) LA-15 SYSTEM (P910018/S006) | Kaneka Pharma America Corp. | 2000-08-21 |