| GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL (P990066/S029) | GE Healthcare | 2007-08-01 |
| CRYOCOR CRYOABLATION SYSTEM (P050024) | Boston Scientific Corp | 2007-08-01 |
| BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S005) | Siemens Healthcare Diagnostics, Inc. | 2007-08-01 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE S4URFACE (P040037/S004) | W. L. Gore & Associates, Inc. | 2007-07-31 |
| STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S006) | Abbott Vascular Devices | 2007-07-30 |
| UROLUME URETHRAL STENT (P920023/S021) | Boston Scientific Corp | 2007-07-27 |
| SECONDLOOK (P010038/S014) | Icad, Inc. | 2007-07-27 |
| CAPSURE SP & CAPSURE Z (P850089/S056) | Medtronic Cardiac Rhythm Disease Management | 2007-07-27 |
| MACROPLASTIQUE IMPLANTS (P040050/S001) | Uroplasty, LLC | 2007-07-27 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S005) | Boston Scientific Corp | 2007-07-27 |
| THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S018) | Boston Scientific Corp | 2007-07-27 |
| THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (P870072/S036) | Thoratec Laboratories Corp. | 2007-07-27 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S021) | CooperSurgical, Inc. | 2007-07-27 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S057) | Advanced Bionics | 2007-07-27 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S009) | Boston Scientific Corp | 2007-07-27 |
| SUREFIX (P930039/S023) | Medtronic, Inc. | 2007-07-27 |
| CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS) (P030002/S010) | Bausch & Lomb, Inc. | 2007-07-26 |
| THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR (P060019/S003) | Irvine Biomedical, Inc. | 2007-07-26 |
| NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR (P010019/S006) | Alcon Laboratories, Inc. | 2007-07-26 |
| PHILOS FAMILY OF PULSE GENERATORS (P950037/S052) | Biotronik, Inc. | 2007-07-25 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S019) | W. L. Gore & Associates, Inc. | 2007-07-25 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S011) | Medtronic Ats Medical, Inc. | 2007-07-25 |
| QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS (P030054/S049) | ABBOTT MEDICAL | 2007-07-25 |
| LINOX S AND LINOX T ICD LEADS (P980023/S028) | Biotronik, Inc. | 2007-07-25 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S013) | W. L. Gore & Associates, Inc. | 2007-07-25 |
| LUMAX FAMILY OF CRT-DS (P050023/S005) | Biotronik, Inc. | 2007-07-25 |
| COSEAL SURGICAL SEALANT (P030039/S005) | Baxter Bio Science | 2007-07-24 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S025) | Med-El Corp. | 2007-07-24 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S024) | Med-El Corp. | 2007-07-24 |
| COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S013) | Integra Lifesciences Corp. | 2007-07-24 |
| PATHWAY HER-2/NEU CONTROL SLIDES (P990081/S006) | Ventana Medical Systems, Inc. | 2007-07-24 |
| EPIC HF FAMILY OF CRT-DS (P030054/S059) | ABBOTT MEDICAL | 2007-07-24 |
| CADENCE FAMILY OF ICDS (P910023/S143) | ABBOTT MEDICAL | 2007-07-24 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S019) | Boston Scientific Corp | 2007-07-24 |
| ATS OPEN PIVOT? BILEAFLET HEART VALVE 35 MM MITRAL VALVE (P990046/S017) | Medtronic Ats Medical, Inc. | 2007-07-23 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002) | Bard Peripheral Vascular | 2007-07-23 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S025) | Integra LifeSciences Corporation | 2007-07-20 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S028) | Integra LifeSciences Corporation | 2007-07-20 |
| PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM INTRODUCER (P030017/S022) | Boston Scientific Corp | 2007-07-18 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD) (P940034/S017) | Gen-Probe, Inc. | 2007-07-18 |
| VARIOUS FAMILIES OF ICDS (P980016/S097) | Medtronic Cardiac Rhythm Disease Management | 2007-07-17 |
| PROTEGE GPS & RX CAROTID STENT SYSTEMS (P060001/S002) | Medtronic Vascular, Inc. | 2007-07-17 |
| THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR (P060019/S002) | Irvine Biomedical, Inc. | 2007-07-17 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S001) | Medtronic Vascular, Inc. | 2007-07-17 |
| VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT (P990037/S025) | Vascular Solutions, Inc. | 2007-07-17 |
| VARIOUS FAMILIES OF ICDS (P980050/S026) | Medtronic, Inc. | 2007-07-17 |
| VARIOUS FAMILIES OF CRT-ICDS (P010031/S065) | Medtronic Cardiac Rhythm Disease Management | 2007-07-17 |
| GENESEARCH BREAST LYMPH NODE(BLN) ASSAY (P060017) | Janssen Diagnostics | 2007-07-16 |
| PRESTIGE CERVICAL DISC SYSTEM (P060018) | Medtronic Sofamor Danek, Inc. | 2007-07-16 |
| TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003 (P990080/S024) | Johnson & Johnson Surgical Vision, Inc. | 2007-07-16 |
| HTA SYSTEM (P000040/S011) | Axora Medical, Inc. | 2007-07-16 |
| COSMETIC TISSUE AUGMENTATION PRODUCT (P050033/S001) | Anika Therapeutics, Inc. | 2007-07-16 |
| THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR (P060019/S001) | Irvine Biomedical, Inc. | 2007-07-13 |
| CORDIS PTCA DILATATION CATHETER (P880003/S092) | Cordis Corp. | 2007-07-13 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S007) | Irvine Biomedical,Inc.(Ibi) | 2007-07-13 |
| APLIGRAF (P950032/S044) | Organogenesis, Inc. | 2007-07-13 |
| IBI THERAPY CARDIAC ABLATION SYSTEM ERS/1500T RF GENERATOR (P040014/S005) | Irvine Biomedical, Inc. | 2007-07-13 |
| CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM (P030047/S003) | Cordis US Corporation | 2007-07-12 |
| ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S002) | Spectranetics Corp. | 2007-07-12 |
| INDENTITY & IDENTITY ADX FAMILY OF DEVICES (P880086/S150) | ABBOTT MEDICAL | 2007-07-12 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S019) | Medtronic Minimed | 2007-07-11 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S037) | Cordis Corp. | 2007-07-11 |
| SEPRAFILM ADHESION BARRIER (P950034/S027) | Baxter Healthcare Corporation | 2007-07-11 |
| RESTYLANE INJECTABLE GEL (P040024/S010) | Q-Med AB | 2007-07-11 |
| EUFLEXXA 1% SODIUM HYALURONATE (P010029/S006) | Ferring Pharmaceuticals, Inc. | 2007-07-11 |
| STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM (P930016/S025) | Amo Manufacturing USA, LLC | 2007-07-11 |
| DEFLUX INJECTABLE GEL (P000029/S027) | Palette Life Sciences | 2007-07-10 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S015) | Medifocus, Inc. | 2007-07-10 |
| VITATRON (P990001/S028) | Medtronic, Inc. | 2007-07-10 |
| AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S016) | Johnson & Johnson Surgical Vision, Inc. | 2007-07-10 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S142) | ABBOTT MEDICAL | 2007-07-10 |
| TECNIS ACRYLIC IOLS (P990080/S025) | Johnson & Johnson Surgical Vision, Inc. | 2007-07-10 |
| REZOOM MULTIFOCAL INTRAOCULAR LENSES (IOLS) (P960028/S022) | Johnson & Johnson Surgical Vision, Inc. | 2007-07-10 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S014) | Gynecare, Inc. | 2007-07-06 |
| RESTYLANE INJECTABLE GELS (P040024/S011) | Q-Med AB | 2007-07-06 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S025) | W. L. Gore & Associates, Inc. | 2007-07-05 |
| CORDIS PCTA DILATATION CATHETERS (P880003/S091) | Cordis Corp. | 2007-07-05 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S015) | Biomet Manufacturing Corp | 2007-07-05 |
| ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT (P020018/S024) | Cook, Inc. | 2007-07-05 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039) | Exactech, Inc. | 2007-07-05 |
| TORAY INOUE BALLON CATHETER (P910054/S004) | Toray Industries (America), Inc. | 2007-07-03 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S014) | Medifocus, Inc. | 2007-07-03 |
| STAN S31 FETAL HEART MONITOR (P020001/S001) | Neoventa Medical AB | 2007-07-03 |
| ANEURX AAADVANTAGE STENT GRAFT (P990020/S026) | Medtronic Vascular | 2007-07-03 |
| CORMET HIP RESURFACING SYSTEM (P050016) | Corin USA | 2007-07-03 |
| INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE (P000058/S021) | Medtronic Sofamor Danek USA, Inc. | 2007-07-03 |
| MEDTRONIC SPRINT FIDELIS LEAD (P920015/S037) | Medtronic, Inc. | 2007-07-03 |
| INFUSE BONE GRAFT (P000054/S010) | Medtronic Sofamor Danek USA, Inc. | 2007-07-03 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S058) | Advanced Bionics | 2007-07-02 |
| VNS THERAPY SYSTEM (P970003/S076) | LivaNova USA, Inc. | 2007-06-29 |
| PRECISE AND PRECISE RX NITINOL STENT SYSTEMS (P030047/S004) | Cordis US Corporation | 2007-06-29 |
| VARIOUS FAMILIES OF ICD'S (P980016/S103) | Medtronic Cardiac Rhythm Disease Management | 2007-06-29 |
| VARIOUS FAMILIES OF INSYNC CRT ICDS & CONCERTO CRT-ICD (P010031/S071) | Medtronic Cardiac Rhythm Disease Management | 2007-06-29 |
| EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S009) | Bausch & Lomb, Inc. | 2007-06-29 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS & CCT. CRYOCONSOLE (P020045/S022) | Medtronic Cryocath, LP | 2007-06-29 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S029) | Cordis Corp. | 2007-06-29 |
| VNS THERAPY SYSTEM (P970003/S079) | LivaNova USA, Inc. | 2007-06-29 |
| ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE (P950029/S030) | MicroPort CRM USA, Inc. | 2007-06-29 |
| HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM (P920014/S027) | Thoratec Corp | 2007-06-29 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S023) | Boston Scientific Corp | 2007-06-29 |