| CONTAK RENEWAL TR (P030005/S023) | Guidant Corp. | 2005-11-30 |
| ST JUDES MEDICAL ICDS AND CRT-DS (P030054/S014) | ABBOTT MEDICAL | 2005-11-28 |
| ST JUDES MEDICAL ICD (P910023/S085) | ABBOTT MEDICAL | 2005-11-28 |
| CONTAK RENEWAL (P010012/S066) | Boston Scientific Corp | 2005-11-24 |
| PRIZM FAMILY (P960040/S075) | Boston Scientific | 2005-11-24 |
| VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (P990052/S011) | Med-El Elektromedizinische Gerate GmbH | 2005-11-23 |
| RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219 (P010012/S079) | Boston Scientific Corp | 2005-11-23 |
| INTACS PRESCRIPTION INSERTS (P980031/S009) | Addition Technology | 2005-11-23 |
| RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS (P910073/S058) | Boston Scientific | 2005-11-23 |
| MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S077) | Medtronic, Inc. | 2005-11-22 |
| RX VOYAGER CORONARY DILATATION CATHETER (P810046/S217) | Advanced Cardiovascular Systems, Inc. | 2005-11-22 |
| MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809 (P890003/S095) | Medtronic, Inc. | 2005-11-22 |
| VITATRON SOFTWARE MULTIPLE SOFTWARE MODELS (P990001/S020) | Medtronic, Inc. | 2005-11-22 |
| RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S057) | Boston Scientific | 2005-11-22 |
| X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001) | Medtronic Sofamor Danek, Inc. | 2005-11-21 |
| GEM 21S (GROWTH-FACTOR ENHANCED MATRIX (P040013) | Lynch Biologics, LLC | 2005-11-18 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S012) | Medtronic Cryocath, LP | 2005-11-18 |
| PHOTON, EPIC, AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND CARDIAC RESYNCHRONIZATION THERAPY (P910023/S087) | ABBOTT MEDICAL | 2005-11-18 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S011) | Medtronic Cryocath, LP | 2005-11-18 |
| PHOTON, EPIC, AND ATLAS FAMILIES OF ICDS AND CRT-DS (P030054/S017) | ABBOTT MEDICAL | 2005-11-18 |
| EPIC AND ATLAS+ HF CRT-D SYSTEMS (P030054/S010) | ABBOTT MEDICAL | 2005-11-18 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER (P040042) | Irvine Biomedical,Inc.(Ibi) | 2005-11-18 |
| LCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM (P830055/S092) | Depuy, Inc. | 2005-11-17 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S001) | Smith & Nephew, Inc. | 2005-11-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATORS (P000044/S009) | Ortho-Clinical Diagnostics, Inc. | 2005-11-17 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S010) | Boston Scientific Corp | 2005-11-17 |
| GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S017) | ABBOTT MEDICAL | 2005-11-16 |
| SELUTE AND SELUTE PICOTIP (P950001/S015) | Boston Scientific | 2005-11-15 |
| MEDTRONIC PACEMAKER SYSTEM (P890003/S091) | Medtronic, Inc. | 2005-11-15 |
| MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS (P010031/S028) | Medtronic Cardiac Rhythm Disease Management | 2005-11-15 |
| MEDTRONIC MODEL 9996 AND MODEL 9997 (P980016/S055) | Medtronic Cardiac Rhythm Disease Management | 2005-11-15 |
| MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS (P980016/S058) | Medtronic Cardiac Rhythm Disease Management | 2005-11-15 |
| ENDOTAK RELIANCE AND ENDOTAK ENDURANCE (P910073/S055) | Boston Scientific | 2005-11-15 |
| AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES (P030054/S015) | ABBOTT MEDICAL | 2005-11-15 |
| VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS (P960040/S086) | Boston Scientific | 2005-11-10 |
| COAPTITE (P040047) | Merz North America, Inc. | 2005-11-10 |
| CONTAK RENEWAL 1 (P010012/S076) | Boston Scientific Corp | 2005-11-10 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S025) | Boston Scientific Corp | 2005-11-10 |
| ELECSYS HBSAG TEST SYSTEM (P990012/S003) | Roche Diagnostics Corp. | 2005-11-09 |
| VNS THERAPY SYSTEM (P970003/S059) | LivaNova USA, Inc. | 2005-11-08 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S036) | Medtronic Neuromodulation | 2005-11-08 |
| VNS THERAPY SYSTEM (P970003/S060) | LivaNova USA, Inc. | 2005-11-08 |
| SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+ (P840001/S082) | Medtronic Neuromodulation | 2005-11-04 |
| ST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS (P950022/S025) | ABBOTT MEDICAL | 2005-11-04 |
| SYNCHROMED II PROGRAMMABLE DRUG INFUSION PUMP (P860004/S074) | Medtronic, Inc. | 2005-11-03 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC (P010051/S003) | Siemens Healthcare Diagnostics Products, Ltd. | 2005-11-02 |
| HYLAFORM AND HYLAFORM PLUS (P030032/S004) | Genzyme Biosurgery | 2005-11-02 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS (P010052/S003) | Siemens Healthcare Diagnostics Products, Ltd. | 2005-11-02 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) (P030054/S013) | ABBOTT MEDICAL | 2005-11-02 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM (P010053/S003) | Siemens Healthcare Diagnostics Products, Ltd. | 2005-11-02 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) (P910023/S084) | ABBOTT MEDICAL | 2005-11-02 |
| STAN S31 FETAL HEART MONITOR (P020001) | Neoventa Medical AB | 2005-11-01 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (TIPS) (P930031/S024) | Boston Scientific Corp | 2005-10-31 |
| MAGIC WALLSTENT ENDOPROSTHESIS (P980009/S013) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| PTCA CATHETERS (P880027/S064) | Boston Scientific | 2005-10-31 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC) (P940019/S019) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| TAXUS EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEM (P030025/S016) | Boston Scientific Corp | 2005-10-31 |
| RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S021) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS (P020009/S021) | Boston Scientific Scimed, Inc. | 2005-10-31 |
| DEFLUX INJECTABLE GEL (P000029/S015) | Palette Life Sciences | 2005-10-31 |
| SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S007) | Hologic, Inc. | 2005-10-31 |
| PTCA CATHETERS (P860019/S203) | Scimed Life Systems, Inc. | 2005-10-31 |
| WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS) (P980033/S013) | Boston Scientific Corporation | 2005-10-31 |
| DEFLUX SYRINGE (P000029/S014) | Palette Life Sciences | 2005-10-28 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S006) | Boston Scientific Scimed, Inc. | 2005-10-28 |
| SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S001) | Syncardia Systems, LLC | 2005-10-26 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S001) | Integra LifeSciences Corporation | 2005-10-25 |
| PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY (P990081/S002) | Ventana Medical Systems, Inc. | 2005-10-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S034) | Cochlear Americas | 2005-10-21 |
| RESTYLANE (P020023/S012) | Q-Med AB | 2005-10-21 |
| NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS (P010068/S007) | Biosense Webster, Inc. | 2005-10-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S008) | Ortho-Clinical Diagnostics, Inc. | 2005-10-21 |
| MEDTRONIC PACEMAKER SYSTEMS (P890003/S089) | Medtronic, Inc. | 2005-10-20 |
| EUFLEXXA (P010029/S002) | Ferring Pharmaceuticals, Inc. | 2005-10-20 |
| MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEMS (P010031/S026) | Medtronic Cardiac Rhythm Disease Management | 2005-10-20 |
| MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P900061/S057) | Medtronic Cardiac Rhythm Disease Management | 2005-10-20 |
| MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P980016/S056) | Medtronic Cardiac Rhythm Disease Management | 2005-10-20 |
| MEDTRONIC PACEMAKER SYSTEMS (P980035/S047) | Medtronic, Inc. | 2005-10-20 |
| MEDTRONIC NEUROSTIMULATION SYSTEMS (P840001/S081) | Medtronic Neuromodulation | 2005-10-20 |
| ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER IOL (P880091/S019) | Staar Surgical Co. | 2005-10-19 |
| MAESTRO 3000 TM CARDIAC ABLATION SYSTEM (P020025/S012) | Boston Scientific | 2005-10-18 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P980003/S016) | Boston Scientific Corp | 2005-10-18 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM & CATHETERS (P920047/S028) | Boston Scientific Corp | 2005-10-18 |
| NC STORMER OTW BALLOON DILATATION CATHETER (P790017/S084) | Medtronic, Ireland | 2005-10-17 |
| SENOGRAPHE DS & 2000D FFDM SYSTEM (P990066/S022) | GE Healthcare | 2005-10-17 |
| ICD/CRT-D (P030054/S012) | ABBOTT MEDICAL | 2005-10-17 |
| ISOFLEX S LEAD MODEL 1646T (P960030/S013) | ABBOTT MEDICAL | 2005-10-17 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES (ICD AND CRT-D) (P910023/S083) | ABBOTT MEDICAL | 2005-10-17 |
| RELIANCE LEADS (P910073/S056) | Boston Scientific | 2005-10-17 |
| ALCON LADARVISION 4000 EXCIMER LASER SYSTEM- (P970043/S021) | Alcon Laboratories | 2005-10-14 |
| AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P880086/S109) | ABBOTT MEDICAL | 2005-10-14 |
| CIONNI CAPSULAR TENSION RINGS (P010059/S002) | Morcher GmbH | 2005-10-14 |
| MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM (P020031/S002) | Microsulis Medical , Ltd. | 2005-10-14 |
| JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S001) | Euclid Vision Corporation | 2005-10-14 |
| AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE (P000039/S010) | ABBOTT MEDICAL | 2005-10-13 |
| AMPLATZER DUCT OCCLUDER (P020024/S005) | ABBOTT MEDICAL | 2005-10-13 |
| MERLIN PATIENT CARE SYSTEM MODEL 3650 (P030054/S008) | ABBOTT MEDICAL | 2005-10-12 |
| CONTAK RENEWAL TR (P030005/S020) | Guidant Corp. | 2005-10-12 |
| XACT CAROTID STENT SYSTEM (P040038/S001) | Abbott Vascular, Inc. | 2005-10-12 |
| BAYER ADVIA IMS COMPLEXED PSA ASSAY (P990055/S008) | Siemens Healthcare Diagnostics | 2005-10-07 |