| PROLIEVE THERMODILITATION SYSTEM (P030006/S018) | Medifocus, Inc. | 2008-10-16 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S023) | Baxter Healthcare Corp | 2008-10-16 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S066) | Advanced Bionics | 2008-10-15 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S086) | Boston Scientific Corp | 2008-10-15 |
| ACRYSOF SINGLE-PIECE INTRAOCULAR LENSES (IOL) (P930014/S028) | Alcon Laboratories, Inc. | 2008-10-15 |
| REALIZE ADJUSTABLE GASTRIC BAND (P070009/S003) | Obtech Medical GmbH | 2008-10-15 |
| PRODISC L TOTAL DISC REPLACEMENT (P050010/S002) | Centinel Spine, LLC | 2008-10-14 |
| ENDOLOGIX POWERLINK SYSTEM, VISIFLEX IS DELIVERY SYSTEM (P040002/S021) | Endologix, LLC | 2008-10-14 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S003) | Smith & Nephew, Inc. | 2008-10-14 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S087) | Boston Scientific Corp | 2008-10-14 |
| CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A (P890003/S148) | Medtronic, Inc. | 2008-10-14 |
| SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950) (P890055/S025) | Intera Oncology | 2008-10-10 |
| LCS TOTAL KNEE SYSTEM (P830055/S104) | Depuy, Inc. | 2008-10-10 |
| HER2FISH PHARMDX KIT (P040005/S003) | Agilent Technologies Singapore (International) Pte , Ltd. | 2008-10-10 |
| BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 (P990019/S005) | Sun Pharmaceutical Industries, Inc. | 2008-10-10 |
| HELIOS II ABLATION CATHETER (P050029) | Stereotaxis, Inc. | 2008-10-10 |
| ENRHYTHM IPG (P980035/S115) | Medtronic, Inc. | 2008-10-10 |
| STEEROCATH T CARDIAC ABLATION CATHETER (P920047/S038) | Boston Scientific Corp | 2008-10-10 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S062) | Boston Scientific Corp | 2008-10-10 |
| NC SPRINTER RX BALLOON DILATATION CATHETER (P790017/S095) | Medtronic, Ireland | 2008-10-10 |
| VARIOUS FAMILIES OF ICDS (P980016/S153) | Medtronic Cardiac Rhythm Disease Management | 2008-10-10 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P060008) | Boston Scientific Corp | 2008-10-10 |
| C-SERIES AND T-SERIES DEVICES (P990001/S044) | Medtronic, Inc. | 2008-10-10 |
| QUICKFLEX FAMILY OF LEADS (P030054/S105) | ABBOTT MEDICAL | 2008-10-10 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S006) | Abbott Vascular, Inc. | 2008-10-10 |
| INSYNCII/ III PROTECT/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/CONCERTO/MAXIMO II (P010031/S121) | Medtronic Cardiac Rhythm Disease Management | 2008-10-10 |
| SJM ISOFLEX OPTIM LEADS (P960030/S023) | ABBOTT MEDICAL | 2008-10-09 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S001) | Bio-Rad Laboratories, Inc. | 2008-10-09 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S019) | Boston Scientific Corp | 2008-10-09 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S (P020026/S048) | Cordis Corp. | 2008-10-09 |
| FINELINE II STEROX EZ LEADS (P960004/S041) | Boston Scientific | 2008-10-09 |
| SECONDLOOK (SL) CAD (P010038/S015) | Icad, Inc. | 2008-10-09 |
| ACTICON ARTIFICIAL BOWEL SPHINCTER (P010020/S011) | Boston Scientific Corp | 2008-10-09 |
| VNS THERAPY PULSE GENERATORS (P970003/S099) | LivaNova USA, Inc. | 2008-10-09 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S037) | Med-El Corp. | 2008-10-09 |
| ISOLINE 2CR (P980049/S039) | MicroPort CRM USA, Inc. | 2008-10-09 |
| ON-X PROSTHETIC HEART VALVE (P000037/S014) | On-X Life Technologies, Inc. | 2008-10-09 |
| BIO-RAD MONOLOSA ANTI-HBC EIA (P060031/S001) | Bio-Rad Laboratories, Inc. | 2008-10-09 |
| QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS (P860019/S227) | Scimed Life Systems, Inc. | 2008-10-08 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S004) | Abbott Laboratories | 2008-10-08 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS (P060001/S006) | Medtronic Vascular, Inc. | 2008-10-08 |
| ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM (P020014/S019) | Bayer Pharma AG | 2008-10-08 |
| POWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES (P040002/S018) | Endologix, LLC | 2008-10-08 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S015) | Ferrosan Meidcal Devices A/S | 2008-10-03 |
| ON-X PROSTHETIC HEART VALVE (P000037/S015) | On-X Life Technologies, Inc. | 2008-10-03 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S036) | Medtronic Minimed | 2008-10-03 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S080) | Boston Scientific Corp | 2008-10-03 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S025) | W. L. Gore & Associates, Inc. | 2008-10-03 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S037) | W. L. Gore & Associates, Inc. | 2008-10-03 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OVER-THE-WIRE (OTW) & RAPID EXCHANGE (RX) & MULTI EXCHANGE II (P060033/S001) | Medtronic, Inc. | 2008-10-02 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S035) | Medtronic Minimed | 2008-10-02 |
| INSYNC FAMILIES OF ICDS (P010031/S120) | Medtronic Cardiac Rhythm Disease Management | 2008-10-02 |
| VARIOUS FAMILIES OF ICDS (P980016/S152) | Medtronic Cardiac Rhythm Disease Management | 2008-10-02 |
| MONOPREP PAP TEST (P040052/S007) | Hologic, Inc. | 2008-10-01 |
| AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS (P880086/S168) | ABBOTT MEDICAL | 2008-10-01 |
| MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT (P980035/S098) | Medtronic, Inc. | 2008-10-01 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S047) | ABBOTT MEDICAL | 2008-10-01 |
| MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT (P010031/S101) | Medtronic Cardiac Rhythm Disease Management | 2008-10-01 |
| MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT (P980016/S132) | Medtronic Cardiac Rhythm Disease Management | 2008-10-01 |
| CORONARY FLEXTOME CUTTING BALLOON DEVICE (P950020/S030) | Boston Scientific Corp | 2008-10-01 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S079) | Boston Scientific Corp | 2008-09-30 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S077) | Boston Scientific Corp | 2008-09-30 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER (P900056/S093) | Boston Scientific Corp | 2008-09-30 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S072) | Boston Scientific Corp | 2008-09-30 |
| CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM (P030047/S011) | Cordis US Corporation | 2008-09-30 |
| EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS (P030031/S009) | Biosense Webster, Inc. | 2008-09-30 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S073) | Boston Scientific Corp | 2008-09-30 |
| DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S095) | Cordis Corp. | 2008-09-30 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S101) | Medtronic, Inc. | 2008-09-30 |
| TECNIS ACRYLIC IOL (P990080/S031) | Johnson & Johnson Surgical Vision, Inc. | 2008-09-30 |
| REZOOM MULTIFOCAL ACRYLIC IOL (P960028/S030) | Johnson & Johnson Surgical Vision, Inc. | 2008-09-30 |
| EZ STEER THERMOCOOL AND (P040036/S006) | Biosense Webster, Inc. | 2008-09-30 |
| SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S025) | Johnson & Johnson Surgical Vision, Inc. | 2008-09-30 |
| COAPTITE (P040047/S001) | Merz North America, Inc. | 2008-09-29 |
| FLEXTOME CUTTING BALLOON MONORAIL(MR) AND OVER THE WIRE (OTW) (P950020/S013) | Boston Scientific Corp | 2008-09-29 |
| FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS (P950020/S015) | Boston Scientific Corp | 2008-09-29 |
| RESTYLANE INJECTABLE GEL (P040024/S023) | Q-Med AB | 2008-09-29 |
| FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS (P950020/S014) | Boston Scientific Corp | 2008-09-29 |
| TAXUS EXPRESS2 OTW PACLITAXEL ELUTING STENT SYSTEM (P030025/S058) | Boston Scientific Corp | 2008-09-26 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S013) | Starr Surgical Co. | 2008-09-26 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S052) | Terumo Medical Corporation | 2008-09-26 |
| MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER (P860019/S228) | Scimed Life Systems, Inc. | 2008-09-26 |
| COSEAL SURGICAL SEALANT (P030039/S011) | Baxter Bio Science | 2008-09-26 |
| VITALITY AND VITALITY 2 (P960040/S176) | Boston Scientific | 2008-09-26 |
| SJM BIOCOR VALVE & SUPRA VALVE (P040021/S007) | ABBOTT MEDICAL | 2008-09-26 |
| HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS (P080004) | Hoya Surgical Optics, Inc. | 2008-09-26 |
| LIBERTE OTW CORONARY STENT SYSTEM (P040016/S033) | Boston Scientific Scimed, Inc. | 2008-09-26 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S008) | Davol, Inc. | 2008-09-26 |
| EXPRESS2 OTW CORONARY STENT SYSTEM (P020009/S046) | Boston Scientific Scimed, Inc. | 2008-09-26 |
| CONTAK RENEWAL TR (P030005/S054) | Guidant Corp. | 2008-09-26 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY SYSTEMS (P060033/S002) | Medtronic, Inc. | 2008-09-25 |
| VIDAS TOTAL PSA (TPSA) ASSAY (P040008/S001) | bioMerieux, Inc. | 2008-09-25 |
| DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S019) | Medtronic, Ireland | 2008-09-25 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETERS (P790017/S094) | Medtronic, Ireland | 2008-09-25 |
| TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM (P030025/S021) | Boston Scientific Corp | 2008-09-24 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S034) | W. L. Gore & Associates, Inc. | 2008-09-24 |
| CARELINK PERSONAL SOFTWARE (P980022/S033) | Medtronic Minimed | 2008-09-24 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) (P030025/S028) | Boston Scientific Corp | 2008-09-24 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S007) | Roche Diagnostics Corp. | 2008-09-23 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S003) | Bard Peripheral Vascular | 2008-09-23 |