| PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S063) | Abbott Vascular, Inc. | 2008-06-12 |
| POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS (P040002/S017) | Endologix, LLC | 2008-06-12 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY (P000044/S018) | Ortho-Clinical Diagnostics, Inc. | 2008-06-12 |
| CAPSURE SENSE & VITATRON (P830061/S042) | Medtronic Cardiac Rhythm Disease Management | 2008-06-11 |
| CAPSUREFIX NOVUS & VITATRON (P930039/S027) | Medtronic, Inc. | 2008-06-11 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S007) | W. L. Gore & Associates, Inc. | 2008-06-11 |
| ADAPTA/VERSA/SENIA IPG (P980035/S093) | Medtronic, Inc. | 2008-06-11 |
| QUICKSITE AND QUICKFLEX LEADS (P030054/S091) | ABBOTT MEDICAL | 2008-06-11 |
| ESSURE SYSTEM (P020014/S015) | Bayer Pharma AG | 2008-06-10 |
| RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S113) | Medtronic Neuromodulation | 2008-06-10 |
| CIBA VISION EXTENDED WEAR SOFT CONTACT LENSES (P010019/S009) | Alcon Laboratories, Inc. | 2008-06-10 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S092) | Boston Scientific Corp | 2008-06-10 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S057) | St. Jude Medical, Inc. | 2008-06-09 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S024) | ABBOTT MEDICAL | 2008-06-09 |
| PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR (P980023/S033) | Biotronik, Inc. | 2008-06-09 |
| ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P880090/S024) | Bausch & Lomb, Inc. | 2008-06-09 |
| THERAPY CARDIAC ABLATION CATHETERS (P040014/S007) | Irvine Biomedical, Inc. | 2008-06-09 |
| EPIC HF FAMILY CRT-DS (P030054/S089) | ABBOTT MEDICAL | 2008-06-09 |
| THERAPY DUAL 8, THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S012) | Irvine Biomedical,Inc.(Ibi) | 2008-06-09 |
| SYNVISC HYLAN G-F 20 (P940015/S011) | Sanofi Genzyme Corp. | 2008-06-09 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S163) | ABBOTT MEDICAL | 2008-06-09 |
| CADENCE FAMILY OF ICDS (P910023/S176) | ABBOTT MEDICAL | 2008-06-09 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC (P950037/S061) | Biotronik, Inc. | 2008-06-09 |
| PHYLAX AV ICD SYSTEM (P000009/S028) | Biotronik, Inc. | 2008-06-09 |
| KRONOS LV-T CRT-D (P050023/S013) | Biotronik, Inc. | 2008-06-09 |
| SJM LEADS (P960030/S022) | ABBOTT MEDICAL | 2008-06-09 |
| TENDRIL (P960013/S040) | ABBOTT MEDICAL | 2008-06-09 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S042) | ABBOTT MEDICAL | 2008-06-09 |
| DURATA, RIATA ST OPTIM, RIATA ST, RIATA SF (P950022/S053) | ABBOTT MEDICAL | 2008-06-09 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL (P860057/S046) | Edwards Lifesciences, LLC | 2008-06-06 |
| DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S024) | Medtronic, Ireland | 2008-06-06 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S029) | Boston Scientific Corp | 2008-06-06 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S008) | Medtronic, Inc. | 2008-06-06 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S036) | W. L. Gore & Associates, Inc. | 2008-06-05 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007) | Medtronic Vascular | 2008-06-05 |
| PERFLUORON (P950018/S010) | Alcon Laboratories | 2008-06-04 |
| STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013/S020) | Starr Surgical Co. | 2008-06-04 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S027) | Cook, Inc. | 2008-06-04 |
| NMP22 ELISA TEST KIT (P940035/S005) | Abbott Diagnostics Scarborough, Inc. | 2008-06-03 |
| PHYLAX AV ICD SYSTEM (P000009/S027) | Biotronik, Inc. | 2008-06-02 |
| PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR SYSTEM (P980023/S032) | Biotronik, Inc. | 2008-06-02 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEM (P950037/S060) | Biotronik, Inc. | 2008-06-02 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S005) | Abbott Laboratories | 2008-06-02 |
| STRATOS LV & STRATOS LV-T-CRT-P'S (P820076/S024) | Biotronik, Inc. | 2008-06-02 |
| KRONOS LV-T CRT-D (P050023/S012) | Biotronik, Inc. | 2008-06-02 |
| STRATOS LV/LV-T (P070008/S002) | Biotronik, Inc. | 2008-06-02 |
| TECNIS ACRYLIC IOLS (P990080/S030) | Johnson & Johnson Surgical Vision, Inc. | 2008-05-30 |
| REZOOM MULTIFOCAL IOLS (P960028/S027) | Johnson & Johnson Surgical Vision, Inc. | 2008-05-30 |
| RESTYLANE INJECTABLE GEL (P040024/S022) | Q-Med AB | 2008-05-30 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S027) | CooperSurgical, Inc. | 2008-05-30 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S005) | Stryker Corp. | 2008-05-30 |
| PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S012) | Bausch & Lomb, Inc. | 2008-05-30 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER (P900056/S091) | Boston Scientific Corp | 2008-05-30 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S015) | Boston Scientific Corp | 2008-05-30 |
| UROLUME URETHRAL STENT (P920023/S024) | Boston Scientific Corp | 2008-05-30 |
| STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013/S019) | Starr Surgical Co. | 2008-05-30 |
| SENSAR ACRYLIC IOLS (P980040/S021) | Johnson & Johnson Surgical Vision, Inc. | 2008-05-30 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S009) | Boston Scientific Corp | 2008-05-30 |
| THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S021) | Boston Scientific Corp | 2008-05-30 |
| MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01 (P970004/S054) | Medtronic Neuromodulation | 2008-05-30 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S009) | W. L. Gore & Associates, Inc. | 2008-05-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S010) | W. L. Gore & Associates, Inc. | 2008-05-29 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S055) | Terumo Medical Corporation | 2008-05-29 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENTS (P020026/S044) | Cordis Corp. | 2008-05-29 |
| TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00 (P980040/S023) | Johnson & Johnson Surgical Vision, Inc. | 2008-05-27 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S006) | Medtronic, Inc. | 2008-05-27 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S040) | Corcym S.r.l. | 2008-05-27 |
| GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S030) | GE Healthcare | 2008-05-27 |
| FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) (P950020/S027) | Boston Scientific Corp | 2008-05-27 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P (P000007/S015) | Edwards Lifesciences, LLC | 2008-05-23 |
| HYALGAN (P950027/S011) | Fidia Farmaceutici S.P.A. | 2008-05-23 |
| DEFLUX INJECTABLE GEL (P000029/S044) | Palette Life Sciences | 2008-05-23 |
| NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S007) | Medinol, Ltd. | 2008-05-23 |
| COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S009) | Coloplast Corp. | 2008-05-23 |
| CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (P010041/S015) | Edwards Lifesciences, LLC | 2008-05-23 |
| CARPENTIER-EDWARDS, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S045) | Edwards Lifesciences, LLC | 2008-05-23 |
| STAAR VISIAN IMPLANTABLE COLLAMER LENS (P030016/S007) | STAAR Surgical Company | 2008-05-23 |
| CARPENTIER-EDWARDS PERIMOUNT PORCINE BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PORCIN MITRAL BIOPROSTHESIS (P870056/S028) | Edwards Lifesciences, LLC | 2008-05-23 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP (P870077/S027) | Edwards Lifesciences, LLC | 2008-05-23 |
| GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM (P970021/S019) | Gynecare, Inc. | 2008-05-23 |
| HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S012) | Hologic, Inc. | 2008-05-23 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P (P000007/S016) | Edwards Lifesciences, LLC | 2008-05-22 |
| ITREL 3, SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IPG/IMPLANTABLE NEUROSTIMULATOR (P840001/S112) | Medtronic Neuromodulation | 2008-05-22 |
| KINETRA & SOLETRA FAMILY OF NEUROSTIMULATORS (P960009/S050) | Medtronic, Inc. | 2008-05-22 |
| INTERSTIM FAMILY OF NEUROSTIMULATORS (P970004/S055) | Medtronic Neuromodulation | 2008-05-22 |
| FREESTYLE NAVIGATOR (P050020/S003) | Abbott Laboratories | 2008-05-21 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S005) | Medtronic, Inc. | 2008-05-21 |
| VITALITY HE TACHY PULSE GENERATORS (P960040/S166) | Boston Scientific | 2008-05-21 |
| DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S022) | Medtronic, Ireland | 2008-05-21 |
| ABBOTT ARCHITECT AFP (P820060/S023) | Abbott Laboratories | 2008-05-21 |
| CONTAK RENEWAL HEART FAILURE PULSE GENERATORS (P010012/S178) | Boston Scientific Corp | 2008-05-21 |
| ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM (P070016) | William Cook Europe Aps | 2008-05-21 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S030) | Boston Scientific Scimed, Inc. | 2008-05-21 |
| TAXUS EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (P030025/S055) | Boston Scientific Corp | 2008-05-21 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S043) | Boston Scientific Scimed, Inc. | 2008-05-21 |
| NMP22 BLADDERCHEK TEST KIT (P940035/S004) | Abbott Diagnostics Scarborough, Inc. | 2008-05-20 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S011) | Bausch & Lomb | 2008-05-20 |
| APLIGRAF (P950032/S047) | Organogenesis, Inc. | 2008-05-19 |
| PRIZM II & VITALITY FAMILIES OF ICDS (P960040/S165) | Boston Scientific | 2008-05-19 |
| RENEWAL (P010012/S177) | Boston Scientific Corp | 2008-05-19 |