| OLYMPIC COOL-CAP SYSTEM (P040025/S006) | Natus Medical Incorporated | 2008-02-05 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S014) | Boston Scientific Corp | 2008-02-05 |
| HER OPTION OFFICE CRYOABLATION SYSTEM (P000032/S024) | CooperSurgical, Inc. | 2008-02-04 |
| EZ STEER 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS (P010068/S012) | Biosense Webster, Inc. | 2008-02-01 |
| TECNIS 1-PIECE IOL MODEL ZCB00 (P980040/S022) | Johnson & Johnson Surgical Vision, Inc. | 2008-02-01 |
| EZ STEER 4MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS (P990025/S015) | Biosense Webster, Inc. | 2008-02-01 |
| ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P060033) | Medtronic, Inc. | 2008-02-01 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S019) | Hologic, Inc. | 2008-02-01 |
| BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM (P990027/S009) | Technolas Perfect Vision GmbH | 2008-02-01 |
| EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS (P950005/S024) | Biosense Webster, Inc. | 2008-02-01 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S047) | Therakos Development Limited | 2008-02-01 |
| CAPSUREFIX NOVUS & VITATRON (P930039/S024) | Medtronic, Inc. | 2008-02-01 |
| THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM (P870072/S039) | Thoratec Laboratories Corp. | 2008-01-31 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S004) | Medtronic Vascular, Inc. | 2008-01-30 |
| VARIOUS ICD FAMILIES & LATITUDE COMMUNICATOR (P910077/S083) | Boston Scientific | 2008-01-30 |
| PRIZM & VITALITY PG CONFIENT ICD (P960040/S156) | Boston Scientific | 2008-01-30 |
| RENEWAL 3 RF CONTAK & RENEWAL PG, LIVIAN CRT-D (P010012/S166) | Boston Scientific Corp | 2008-01-30 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S016) | Gynecare, Inc. | 2008-01-29 |
| FULLTERM FETAL FIBRONECTIN TEST (P920048/S005) | Hologic, Inc. | 2008-01-29 |
| RADIESSE INJECTABLE IMPLANT (P050037/S005) | Merz North America, Inc. | 2008-01-28 |
| RADIESSE INJECTABLE IMPLANT (P050052/S006) | Merz North America, Inc. | 2008-01-25 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S002) | ABBOTT MEDICAL | 2008-01-25 |
| PRIZM, PRIZM AT & VITALITY FAMILES (P960040/S157) | Boston Scientific | 2008-01-25 |
| COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990013/S014) | Starr Surgical Co. | 2008-01-25 |
| VITALITY HE (P960040/S158) | Boston Scientific | 2008-01-25 |
| CONTAK RENEWAL (P010012/S169) | Boston Scientific Corp | 2008-01-25 |
| PRODISC-L TOTAL DISC REPLACEMENT (P050010/S001) | Centinel Spine, LLC | 2008-01-25 |
| CONTAK RENEWAL FAMILY (P010012/S168) | Boston Scientific Corp | 2008-01-25 |
| ELEVESS (P050033/S004) | Anika Therapeutics, Inc. | 2008-01-24 |
| EPIC HF FAMILY OF CRT-DS (P030054/S078) | ABBOTT MEDICAL | 2008-01-24 |
| CADENCE FAMILY OF ICDS (P910023/S166) | ABBOTT MEDICAL | 2008-01-24 |
| SENSAR ACRYLIC MONOFOCAL IOLS (P980040/S020) | Johnson & Johnson Surgical Vision, Inc. | 2008-01-23 |
| REZOOM MULTIFOCAL IOLS (P960028/S026) | Johnson & Johnson Surgical Vision, Inc. | 2008-01-23 |
| TECNIS ACRYLIC MONOFOCAL IOLS (P990080/S029) | Johnson & Johnson Surgical Vision, Inc. | 2008-01-23 |
| CGMS IPRO SYSTEM (P980022/S020) | Medtronic Minimed | 2008-01-22 |
| VISTAKON SENOFILCON A CONTACT LENS FOR EXTENDED WEAR (P040045/S003) | Vistakon, Division of Johnson & Johnson Vision Car | 2008-01-18 |
| SIR-SPHERES (P990065/S004) | Sirtex Medical, Inc. | 2008-01-18 |
| CADENCE ICDS (P910023/S165) | ABBOTT MEDICAL | 2008-01-17 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S027) | Boston Scientific Scimed, Inc. | 2008-01-17 |
| INTERSTIM THERAPY (P970004/S047) | Medtronic Neuromodulation | 2008-01-17 |
| BIOMET BHS- MINI (P790002/S025) | Ahp Eos Buyer, Inc. | 2008-01-17 |
| SPINAL CORD STIMULATION (P840001/S105) | Medtronic Neuromodulation | 2008-01-17 |
| CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD (P000049/S019) | Nmt Medical, Inc. | 2008-01-17 |
| CONTAK TR 2 (P030005/S049) | Guidant Corp. | 2008-01-17 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S008) | Abbott Vascular Devices | 2008-01-17 |
| EPIC HF CRT-DS (P030054/S077) | ABBOTT MEDICAL | 2008-01-17 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S052) | Boston Scientific Corp | 2008-01-17 |
| ENTRUST & VIRTUOSO (P980016/S119) | Medtronic Cardiac Rhythm Disease Management | 2008-01-16 |
| STAAR SURGICAL SILICONE UV - ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S024) | Staar Surgical Co. | 2008-01-16 |
| CONCERTO (P980035/S084) | Medtronic, Inc. | 2008-01-16 |
| ENRHYTHM (P010031/S089) | Medtronic Cardiac Rhythm Disease Management | 2008-01-16 |
| CORDIS PRECISE RX NITINOL STENT SYSTEM (P030047/S010) | Cordis US Corporation | 2008-01-16 |
| STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM (P930016/S030) | Amo Manufacturing USA, LLC | 2008-01-16 |
| ISOLINE 2CR DEFIBRILLATION LEADS (P980049/S021) | MicroPort CRM USA, Inc. | 2008-01-15 |
| INFUSE BONE GRAFT (P050053/S004) | Medtronic, Inc. | 2008-01-14 |
| INFUSE BONE GRAFT (P000054/S013) | Medtronic Sofamor Danek USA, Inc. | 2008-01-14 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S025) | Medtronic Sofamor Danek USA, Inc. | 2008-01-14 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S004) | Davol, Inc. | 2008-01-14 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) (P980022/S022) | Medtronic Minimed | 2008-01-11 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S010) | Allergan, Inc. | 2008-01-11 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S008) | Roche Molecular Systems, Inc. | 2008-01-11 |
| ITREL3,SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR INPLANTABLE NEUROSTIMULATOR (P840001/S099) | Medtronic Neuromodulation | 2008-01-11 |
| COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST (P000012/S015) | Roche Molecular Systems, Inc. | 2008-01-11 |
| INTERSTIM FAMILY OF NEUROSTIMULATOR (P970004/S042) | Medtronic Neuromodulation | 2008-01-11 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S007) | Abbott Vascular Devices | 2008-01-11 |
| DAKO TOP2A FISH PHARMDX KIT (P050045) | Dako Denmark A/S | 2008-01-11 |
| VASOSEAL (P920004/S021) | St. Jude Medical, Inc. | 2008-01-11 |
| AMPLICOR HEPATITIS C VIRUS (HCV) TEST (P000010/S011) | Roche Molecular Systems, Inc. | 2008-01-11 |
| SYNCHROMED II PUMP (P860004/S093) | Medtronic, Inc. | 2008-01-11 |
| CADENCE ICDS (P910023/S164) | ABBOTT MEDICAL | 2008-01-11 |
| KINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR (P960009/S043) | Medtronic, Inc. | 2008-01-11 |
| DEXCOM SEVEN SYSTEM (P050012/S013) | Dexcom, Inc. | 2008-01-11 |
| FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P020037/S002) | Abbott Vascular, Inc. | 2008-01-11 |
| EPIC HF CRT-DS (P030054/S076) | ABBOTT MEDICAL | 2008-01-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S016) | W. L. Gore & Associates, Inc. | 2008-01-11 |
| PEPGEN 15 (P990033/S015) | Ceramed Corp. | 2008-01-11 |
| DURATA (P950022/S049) | ABBOTT MEDICAL | 2008-01-10 |
| ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7 (P980049/S024) | MicroPort CRM USA, Inc. | 2008-01-09 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S011) | Carbon Medical Technologies, Inc. | 2008-01-09 |
| HYALGAN (P950027/S010) | Fidia Farmaceutici S.P.A. | 2008-01-08 |
| RESTOREULTRA RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S097) | Medtronic Neuromodulation | 2008-01-08 |
| NAVISTAR RMT THERMOCOOL LINE EXTENSION (P040036/S003) | Biosense Webster, Inc. | 2008-01-04 |
| VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S034) | Alcon Laboratories | 2008-01-04 |
| MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S029) | Medtronic Vascular | 2008-01-04 |
| CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC & ATLAS ICD FAMILIES (P910023/S163) | ABBOTT MEDICAL | 2008-01-04 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S005) | Biosense Webster, Inc. | 2008-01-04 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S021) | Alcon Research, Ltd. | 2008-01-04 |
| MODELS 8090 OR 2290 PACING SYSTEM ANALYZER (P890003/S133) | Medtronic, Inc. | 2008-01-04 |
| EPIC HF & HF CRT-D FAMILIES (P030054/S075) | ABBOTT MEDICAL | 2008-01-04 |
| CONCERTO (P010031/S088) | Medtronic Cardiac Rhythm Disease Management | 2008-01-03 |
| VIRTUOSO (P980016/S118) | Medtronic Cardiac Rhythm Disease Management | 2008-01-03 |