| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S081) | Boston Scientific Corp | 2010-01-29 |
| EPIC HF CRT-D SYSTEM (P030054/S131) | ABBOTT MEDICAL | 2010-01-29 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S007) | Siemens Healthcare Diagnostics | 2010-01-29 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S036) | Boston Scientific Corp | 2010-01-29 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S004) | Biomet Microfixation, Inc. | 2010-01-29 |
| RESTYLANE L AND PERLANE L INJECTABLE GELS (P040024/S039) | Q-Med AB | 2010-01-29 |
| EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S057) | Boston Scientific Scimed, Inc. | 2010-01-29 |
| FREQUENCY TORIC & SPHERE (METHAFILCON A 55%) SOFT (HYDROPHILIC) CONTACT LENSES (P850079/S046) | CooperVision, Inc. | 2010-01-29 |
| X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S012) | Medtronic Sofamor Danek, Inc. | 2010-01-28 |
| DEXCOM SEVEN PLUS SYSTEM (P050012/S022) | Dexcom, Inc. | 2010-01-28 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S023) | Abbott Vascular Devices | 2010-01-27 |
| QUANTIFERON - TB GOLD IN-TUBE (P010033/S015) | Qiagen | 2010-01-25 |
| PMMA INTRAOCULAR LENSES (IOLS) (P840060/S032) | Alcon Laboratories | 2010-01-22 |
| ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGON/PHOENIX PACEMAKERS/CRT-PS (P880086/S184) | ABBOTT MEDICAL | 2010-01-22 |
| FRONTIER/FRONTIER II/ANTHEM/AESCULA PACEMAKERS/CRT-PS (P030035/S065) | ABBOTT MEDICAL | 2010-01-22 |
| STRATOS LV/LV-T (P070008/S014) | Biotronik, Inc. | 2010-01-22 |
| CADENCE/CADET/CONTOUR/CONTOUR II/MD/ATLAS II/MD/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/ATLAS II/+/EPIC II/+/CONVERT (P910023/S228) | ABBOTT MEDICAL | 2010-01-22 |
| TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (P980040/S029) | Johnson & Johnson Surgical Vision, Inc. | 2010-01-22 |
| ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS (P950037/S074) | Biotronik, Inc. | 2010-01-22 |
| RIATA/RIATA ST/RIATA ST OPTIM/DURATA LEADS (P950022/S068) | ABBOTT MEDICAL | 2010-01-22 |
| BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T (P000009/S038) | Biotronik, Inc. | 2010-01-22 |
| ACRYSOF INTRAOCULAR LENSES (IOL) (P930014/S037) | Alcon Laboratories, Inc. | 2010-01-22 |
| QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS (P030054/S143) | ABBOTT MEDICAL | 2010-01-22 |
| LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S028) | Biotronik, Inc. | 2010-01-22 |
| TENDRIL/TENDRIL ST/TENDRIL STS/OPTISENSE LEADS (P960013/S056) | ABBOTT MEDICAL | 2010-01-22 |
| ACTROS & AXIOS & KAIROS DR/SR/SLR/D/S/BA03 DDDR/CYLOS DR/DR-T/VR/DOMOS DR/SR/SL/PHILOS&PHILOS II DR/DR-T/SR/SLR/D/S/PROT (P950037/S076) | Biotronik, Inc. | 2010-01-22 |
| PASSIVE PLUS/ISOFLEX S & P/ISOFLEX OPTIM LEADS (P960030/S029) | ABBOTT MEDICAL | 2010-01-22 |
| ACRYSOF INTRAOCULAR LENSES (IOLS) (P040020/S022) | Alcon Research, Ltd. | 2010-01-22 |
| ACRYSOF INTRAOCULAR LENSES (P880087/S014) | Alcon Laboratories | 2010-01-22 |
| PMMA INTRAOCULAR LENSES (IOLS) (P810032/S055) | Alcon Laboratories | 2010-01-22 |
| STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS (P000020/S013) | Boston Scientific Corp | 2010-01-21 |
| ACTIVA PC IMPLANTABLE NEUROSTIMULATOR (P960009/S076) | Medtronic, Inc. | 2010-01-21 |
| CAPSURE SP NOVUS LEADS AND CAPSURE SP LEADS (P830061/S047) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S077) | Cordis Corp. | 2010-01-21 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP (P010007/S004) | Siemens Healthcare Diagnostics, Inc. | 2010-01-21 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA (P060005/S003) | Siemens Medical Solutions Diagnostics Limited | 2010-01-21 |
| KAPPA 700, 800 / 900 IPG FAMILY (P980035/S145) | Medtronic, Inc. | 2010-01-21 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATION PSA (P930027/S010) | Siemens Healthcare Diagnostics, Inc. | 2010-01-21 |
| MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY (P980016/S209) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM (P990020/S036) | Medtronic Vascular | 2010-01-21 |
| ATTAIN ABILITY LV LEAD (P080006/S003) | Medtronic, Inc. | 2010-01-21 |
| INSYNC II MARQUIS ICD (P010031/S170) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| HERCEPTEST (P980018/S007) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-01-21 |
| C-SERIES IPG DEVICES, T-SERIES IPG DEVICES DEMA FAMILY (P990001/S057) | Medtronic, Inc. | 2010-01-21 |
| PRODIGY IPG AND CAPSURE VDD LEADS (P890003/S175) | Medtronic, Inc. | 2010-01-21 |
| RESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS (P840001/S144) | Medtronic Neuromodulation | 2010-01-21 |
| ATTAIN STARFIX LEAD (P060039/S007) | Medtronic, Inc. | 2010-01-21 |
| CAPSURE Z NOVUS LEADS, CAPSURE Z LEADS, CAPSURE SP LEADS AND CAPSURE SP NOVUS LEADS (P850089/S062) | Medtronic Cardiac Rhythm Disease Management | 2010-01-21 |
| INSYNC CRT-P, INSYNC III CRT-P, ATTAIN OTW LEAD, ATTAIN BIPOLAR OTW LEAD, ATTAIN CS LEAD AND ATTAIN LV LEAD (P010015/S073) | Medtronic, Inc. | 2010-01-21 |
| KAPPA 400 DR IPG AND KAPPA 400 SR IPG (P970012/S058) | Medtronic, Inc. | 2010-01-21 |
| CAPSUREFIX NOVUS LEAD, SUREFIX LEAD (P930039/S033) | Medtronic, Inc. | 2010-01-21 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC (P010051/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM (P010053/S006) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS (P010052/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM (P000032/S030) | CooperSurgical, Inc. | 2010-01-20 |
| INFUSE BONE GRAFT/LT- CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S030) | Medtronic Sofamor Danek USA, Inc. | 2010-01-20 |
| TENDRIL LEADS (P960013/S052) | ABBOTT MEDICAL | 2010-01-20 |
| INFUSE BONE GRAFT (P050053/S010) | Medtronic, Inc. | 2010-01-20 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S005) | ABBOTT MEDICAL | 2010-01-20 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY (P010050/S010) | Siemens Healthcare Diagnostics Products, Ltd. | 2010-01-20 |
| INFUSE BONE GRAFT (P000054/S019) | Medtronic Sofamor Danek USA, Inc. | 2010-01-20 |
| PTCA DILATATION & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS (P880003/S100) | Cordis Corp. | 2010-01-20 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S017) | Abbott Laboratories | 2010-01-19 |
| VENTAK/PRX/VENTAK MINI I-IV (P910077/S101) | Boston Scientific | 2010-01-15 |
| VENTAK (P830060/S065) | Boston Scientific | 2010-01-15 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S018) | Coloplast Corp. | 2010-01-15 |
| SWEET TIP RX/FLEXTEND (P960006/S026) | Boston Scientific | 2010-01-15 |
| CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY (P010012/S232) | Boston Scientific Corp | 2010-01-15 |
| ACUITY STEERABLE (P050046/S006) | Guidant Corp. | 2010-01-15 |
| PRODIGY (P890003/S180) | Medtronic, Inc. | 2010-01-15 |
| ENDOTAK (P910073/S082) | Boston Scientific | 2010-01-15 |
| KAPPA 400 (P970012/S061) | Medtronic, Inc. | 2010-01-15 |
| THINLINE/FINELINE (P960004/S045) | Boston Scientific | 2010-01-15 |
| SELUTE (P950001/S021) | Boston Scientific | 2010-01-15 |
| VENTAK P2 (P930035/S019) | Boston Scientific | 2010-01-15 |
| VENTAK P (P890061/S018) | Boston Scientific | 2010-01-15 |
| ADAPTA/SENSIA/VERSA/RELIA (P980035/S154) | Medtronic, Inc. | 2010-01-15 |
| RES-Q/RES-Q MICRON (P940008/S026) | Boston Scientific | 2010-01-15 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047) | Neomend, Inc. | 2010-01-14 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S034) | Medtronic Sofamor Danek USA, Inc. | 2010-01-14 |
| INFUSE BONE GRAFT (P050053/S013) | Medtronic, Inc. | 2010-01-14 |
| MEDTRONIC INTERSTIM THERAPY (P970004/S069) | Medtronic Neuromodulation | 2010-01-14 |
| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S022) | Edwards Lifesciences, LLC | 2010-01-14 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S023) | Edwards Lifesciences, LLC | 2010-01-14 |
| INFUSE BONE GRAFT (P000054/S023) | Medtronic Sofamor Danek USA, Inc. | 2010-01-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S075) | Cordis Corp. | 2010-01-14 |
| ON-X PROSTHETIC HEART VALVE (P000037/S017) | On-X Life Technologies, Inc. | 2010-01-14 |
| CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S037) | Edwards Lifesciences, LLC | 2010-01-14 |
| CARPENTIER EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S034) | Edwards Lifesciences, LLC | 2010-01-14 |
| ISPAN SULFUR HEXAFLUORIDE SF6 GAS (P900067/S006) | Airgas Therapeutics, LLC | 2010-01-13 |
| ACTIVA THERAPY FOR DBS (P960009/S074) | Medtronic, Inc. | 2010-01-13 |
| ADAPTA/VERSA/SENSIA/RELIA (P980035/S146) | Medtronic, Inc. | 2010-01-13 |
| ISPAN PERFLUOROPROPANE C3F8 GAS (P900066/S009) | Airgas Therapeutics, LLC | 2010-01-13 |
| SECURA/DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR (P980016/S208) | Medtronic Cardiac Rhythm Disease Management | 2010-01-13 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S076) | Medtronic Neuromodulation | 2010-01-13 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S169) | Medtronic Cardiac Rhythm Disease Management | 2010-01-13 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S045) | Medtronic, Inc. | 2010-01-13 |
| IMPLANTABLE NEUROSTIMULATORS FOR SPINAL CORD STIMULATION (P840001/S142) | Medtronic Neuromodulation | 2010-01-13 |
| ACUITY STEERABLE (P050046/S005) | Guidant Corp. | 2010-01-12 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S026) | Hologic, Inc. | 2010-01-12 |