| AFFINITY/INTEGRITY/VICTORY FAMILY PACEMAKERS (P880086/S132) | ABBOTT MEDICAL | 2006-10-25 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S018) | Cook, Inc. | 2006-10-25 |
| FRONTIER/FRONTIER II FAMILY CRT-PS (P030035/S023) | ABBOTT MEDICAL | 2006-10-25 |
| GORE VIATORR TIPS (P040027/S003) | W. L. Gore & Associates, Inc. | 2006-10-25 |
| EPIC HF/ATLAS + HF FAMILY CRT-DS (P030054/S039) | ABBOTT MEDICAL | 2006-10-25 |
| CADENCE FAMILY ICDS (P910023/S120) | ABBOTT MEDICAL | 2006-10-25 |
| MICRONY FAMILY PACEMAKERS (P970013/S012) | ABBOTT MEDICAL | 2006-10-25 |
| CARELINK MONITORS 2490H, AND MODEL 2020A CARDIOSIGHT READER (P890003/S109) | Medtronic, Inc. | 2006-10-20 |
| ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S015) | Johnson & Johnson Surgical Vision, Inc. | 2006-10-20 |
| GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC AND INTRINSIC 30 IMPLANTABLE DEVICES (P980016/S085) | Medtronic Cardiac Rhythm Disease Management | 2006-10-20 |
| CADENCE FAMILY OF ICD'S (P910023/S121) | ABBOTT MEDICAL | 2006-10-20 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S024) | ABBOTT MEDICAL | 2006-10-20 |
| PARAGON/PHOENIX FAMILY OF PACEMAKERS (P830045/S103) | St. Jude Medical, Inc. | 2006-10-20 |
| KAPPA 600/700/800/900 AND ENPULSE FAMILIES OF PACEMAKERS (P980035/S062) | Medtronic, Inc. | 2006-10-20 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S133) | ABBOTT MEDICAL | 2006-10-20 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S040) | ABBOTT MEDICAL | 2006-10-20 |
| MAVERICK PTCA CATHETERS (P860019/S215) | Scimed Life Systems, Inc. | 2006-10-20 |
| INSYNC MARQUIS, INSYNC MAXIMO, INSYNC SENTRY AND INSYNC II MARQUIS (P010031/S052) | Medtronic Cardiac Rhythm Disease Management | 2006-10-20 |
| MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER MODEL 3330 VERSION 5.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE (P970013/S013) | ABBOTT MEDICAL | 2006-10-20 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S046) | St. Jude Medical, Inc. | 2006-10-20 |
| SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS (P990066/S025) | GE Healthcare | 2006-10-20 |
| X-STOP IPD SYSTEM (P040001/S003) | Medtronic Sofamor Danek, Inc. | 2006-10-19 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S013) | Boston Scientific Corp | 2006-10-19 |
| PROSORBA COLUMN (P850020/S024) | Fresenius Hemocare, Inc. | 2006-10-19 |
| CODMAN 3000 PUMP SILICONE CATHETER (P890055/S019) | Intera Oncology | 2006-10-19 |
| FLEXTOME CUTTING BALLOON MONORAIL (P950020/S019) | Boston Scientific Corp | 2006-10-19 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S008) | DePuy Orthopaedics, Inc. | 2006-10-18 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S015) | Cook, Inc. | 2006-10-18 |
| ARRAY MULTIFOCAL INTRAOCULAR LENSES (P990080/S009) | Johnson & Johnson Surgical Vision, Inc. | 2006-10-18 |
| ARCHITECT HBSAG AND HBSAG CONFIRMATORY (P060007/S001) | Abbott Laboratories | 2006-10-18 |
| AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S008) | Johnson & Johnson Surgical Vision, Inc. | 2006-10-18 |
| CEEON INTRAOCULAR LENSES (P960028/S016) | Johnson & Johnson Surgical Vision, Inc. | 2006-10-18 |
| SYNGO LUNG CAD (P050022) | Siemens Medical Solutions USA, Inc. | 2006-10-18 |
| VNS THERAPY SYSTEM (P970003/S071) | LivaNova USA, Inc. | 2006-10-17 |
| EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS (P010012/S140) | Boston Scientific Corp | 2006-10-17 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM (P020018/S013) | Cook, Inc. | 2006-10-17 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S014) | Cook, Inc. | 2006-10-17 |
| PARADIGM REAL TIME ? MMT-522/722 INSULIN PUMP (P980022/S016) | Medtronic Minimed | 2006-10-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S001) | Smith & Nephew, Inc. | 2006-10-13 |
| INDENTITY, VERITY, INTEGRITY & VICTORY PACEMAKERS (P880086/S131) | ABBOTT MEDICAL | 2006-10-13 |
| VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S012) | Med-El Elektromedizinische Gerate GmbH | 2006-10-13 |
| VICTORY PACEMAKERS (P880086/S130) | ABBOTT MEDICAL | 2006-10-13 |
| OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR (P910066/S022) | Djo, LLC | 2006-10-13 |
| THERMATRX OFFICE THERMO THERAPY (P000043/S016) | Boston Scientific Corp | 2006-10-13 |
| FRONTIER II CRT-PS (P030035/S021) | ABBOTT MEDICAL | 2006-10-13 |
| MAVERICK PTCA CATHETERS (P860019/S214) | Scimed Life Systems, Inc. | 2006-10-13 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S002) | Biomet Microfixation, Inc. | 2006-10-13 |
| FRONTIER II PACEMAKERS (P030035/S022) | ABBOTT MEDICAL | 2006-10-13 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S004) | Roche Diagnostics Corp. | 2006-10-13 |
| SURGICEL / SURGICEL NU-KNIT / SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S021) | ETHICON, Inc. | 2006-10-13 |
| SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S005) | Boston Scientific Corp | 2006-10-13 |
| ST JUDE MEDICAL IDENTITY, VERITY, INTEGRITY, VICTORY & AFFINITY PACEMAKERS (P880086/S129) | ABBOTT MEDICAL | 2006-10-12 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S009) | Nidek Co., Ltd. | 2006-10-11 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S002) | Medtronic Cardiac Rhythm Disease Management | 2006-10-11 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S010) | Bayer Pharma AG | 2006-10-11 |
| LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS (P960013/S022) | ABBOTT MEDICAL | 2006-10-10 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S030) | Boston Scientific Scimed, Inc. | 2006-10-06 |
| NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS (P990025/S012) | Biosense Webster, Inc. | 2006-10-06 |
| EPIC II/II + DR/VR AND ATLAS II/II + DR/VR ICDS (P910023/S117) | ABBOTT MEDICAL | 2006-10-06 |
| EPIC II HF & ATLAS II HF CRT-DS (P030054/S037) | ABBOTT MEDICAL | 2006-10-06 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S036) | Boston Scientific Corp | 2006-10-06 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S017) | Boston Scientific Scimed, Inc. | 2006-10-06 |
| THINPREP 2000 SYSTEM (P950039/S017) | Hologic, Inc. | 2006-10-05 |
| PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT (P990033/S008) | Ceramed Corp. | 2006-10-05 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI) (P000015/S008) | Cochlear Americas | 2006-10-05 |
| MEDTRONIC ACTIVA THERAPY SYSTEM (P960009/S040) | Medtronic, Inc. | 2006-10-05 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S039) | Cochlear Americas | 2006-10-05 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S046) | Terumo Medical Corporation | 2006-10-05 |
| NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S017) | Hologic, Inc. | 2006-10-05 |
| ABBOTT AXSYM AUSAB (P060003/S002) | Abbott Laboratories, Inc. | 2006-10-04 |
| THERAPY DUAL CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S005) | Irvine Biomedical,Inc.(Ibi) | 2006-10-03 |
| EXPRESS 2 CORNARY STENT SYSTEM (P020009/S032) | Boston Scientific Scimed, Inc. | 2006-10-03 |
| MAVERICK PTCA CATHETERS (P860019/S213) | Scimed Life Systems, Inc. | 2006-10-03 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE (P990004/S010) | Ferrosan Meidcal Devices A/S | 2006-10-03 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S038) | Boston Scientific Corp | 2006-10-03 |
| RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S018) | Abbott Vascular | 2006-10-02 |
| ANGIOLINK VASCULAR CLOSURE SYSTEM (P040022/S001) | Medtronic Vascular | 2006-10-02 |
| TAXUS EXPRESS PACLITAXE-ELUTING CORONARY STENT SYSTEM (P030025/S037) | Boston Scientific Corp | 2006-09-29 |
| VARIOUS MODELS OF PACEMAKERS (P880086/S128) | ABBOTT MEDICAL | 2006-09-29 |
| CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC, ATLAS, EPIC II, AND ATLAS II ICD FAMILIES (P910023/S118) | ABBOTT MEDICAL | 2006-09-29 |
| EXPRESS 2 CORONARY STENT SYSTEM (P020009/S031) | Boston Scientific Scimed, Inc. | 2006-09-29 |
| MAVERICK PTCA CATHETERS (P860019/S212) | Scimed Life Systems, Inc. | 2006-09-29 |
| STARR EDWARDS SILASTIC BALL PROSTHESIS MODELS 1260 & 6120 (P870038/S008) | Edwards Lifesciences, LLC | 2006-09-29 |
| ST. JUDE MEDICAL EPIC HF, ATLAS + HF, EPIC II HF AND ATLAS II HF CRT-D FAMILIES (P030054/S036) | ABBOTT MEDICAL | 2006-09-29 |
| FRONTIER/FRONTIER II CRT-P (P030035/S020) | ABBOTT MEDICAL | 2006-09-29 |
| CORDIS CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S022) | Cordis Corp. | 2006-09-28 |
| DAKO EGFR PHARMDX KIT (P030044/S002) | Agilent Technologies, Inc. | 2006-09-27 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038) | Davol, Inc. | 2006-09-26 |
| DEXCOM SHORT TERM GLUCOSE SENSOR (STS) (P050012/S004) | Dexcom, Inc. | 2006-09-22 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S003) | Abbott Vascular Devices | 2006-09-22 |
| GEM 21S (P040013/S003) | Lynch Biologics, LLC | 2006-09-22 |
| PUREVISION, PUREVISION TORIC AND PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S010) | Bausch & Lomb, Inc. | 2006-09-22 |
| RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS (P950029/S029) | MicroPort CRM USA, Inc. | 2006-09-22 |
| CORDIS PRECISE NITINOL STENT SYSTEM (P030047) | Cordis US Corporation | 2006-09-22 |
| EPIC II HF & ATLAS II HF CRT-DS (P030054/S035) | ABBOTT MEDICAL | 2006-09-21 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S009) | Allergan, Inc. | 2006-09-21 |
| SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC (P880086/S127) | ABBOTT MEDICAL | 2006-09-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S011) | W. L. Gore & Associates, Inc. | 2006-09-21 |
| EXPRESS 2 MR & OTW CORONARY STENT SYSTEM (P020009/S028) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019/S004) | Sun Pharmaceutical Industries, Inc. | 2006-09-21 |