| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S055) | Abbott Vascular, Inc. | 2010-12-30 |
| TRANSVENOUS DEFIBRILLATION LEAD (P950022/S072) | ABBOTT MEDICAL | 2010-12-29 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S005) | Neomend, Inc. | 2010-12-29 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S101) | Medtronic Neuromodulation | 2010-12-29 |
| POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM (P040002/S030) | Endologix, LLC | 2010-12-29 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S011) | Spectranetics Corp. | 2010-12-29 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S041) | Spectranetics Corp. | 2010-12-29 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S105) | Boston Scientific Corp | 2010-12-29 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS (P980006/S017) | Bausch & Lomb, Inc. | 2010-12-27 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS (P980006/S016) | Bausch & Lomb, Inc. | 2010-12-27 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (P050050/S002) | Djo Global | 2010-12-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S074) | Edwards Lifesciences, LLC | 2010-12-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S178) | ABBOTT MEDICAL | 2010-12-23 |
| COROX OTW-L BP LEFT VENTRICULAR PACING LEAD (P070008/S015) | Biotronik, Inc. | 2010-12-23 |
| ACTIVA SC INS/SOLETRA INS/KINETRA INS (P960009/S102) | Medtronic, Inc. | 2010-12-23 |
| CADENCE FAMILY OF ICDS (P910023/S255) | ABBOTT MEDICAL | 2010-12-23 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR (P980016/S267) | Medtronic Cardiac Rhythm Disease Management | 2010-12-23 |
| INTERSTIM INS (P970004/S100) | Medtronic Neuromodulation | 2010-12-23 |
| CERAMAX CERAMIC HIP SYSTEM (P070026) | DePuy Orthopaedics, Inc. | 2010-12-23 |
| AMPLATZER DUCT OCCLUDER (P020024/S024) | ABBOTT MEDICAL | 2010-12-23 |
| GENESYS HTA SYSTEM (P000040/S018) | Axora Medical, Inc. | 2010-12-23 |
| SPINAL CORD STIMULATION SYSTEMS (P840001/S171) | Medtronic Neuromodulation | 2010-12-23 |
| SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETERS (P060019/S016) | Irvine Biomedical, Inc. | 2010-12-23 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S103) | Medtronic, Inc. | 2010-12-23 |
| LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS (P070014/S010) | Bard Peripheral Vascular, Inc. | 2010-12-23 |
| ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS (P840001/S170) | Medtronic Neuromodulation | 2010-12-23 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S221) | Medtronic Cardiac Rhythm Disease Management | 2010-12-23 |
| SEPRAFILM ADHESION BARRIER (P950034/S038) | Baxter Healthcare Corporation | 2010-12-22 |
| AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S085) | Boston Scientific Corp | 2010-12-22 |
| RADIESSE INJECTABLE IMPLANT (P050037/S025) | Merz North America, Inc. | 2010-12-22 |
| AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S086) | Boston Scientific Corp | 2010-12-22 |
| IMPLANTABLE DRUG DELIVERY SYSTEM (P800036/S037) | Intera Oncology | 2010-12-22 |
| ACTIVA SC/SOLETRA/KINETRA INS (P960009/S101) | Medtronic, Inc. | 2010-12-22 |
| RADIESSE INJECTABLE IMPLANT (P050052/S028) | Merz North America, Inc. | 2010-12-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS WITH MODIFIED DELIVERY SYSTEM (P020004/S052) | W. L. Gore & Associates, Inc. | 2010-12-22 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S037) | Edwards Lifesciences, LLC | 2010-12-22 |
| EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S026) | Edwards Lifesciences, LLC | 2010-12-22 |
| CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES (P870056/S041) | Edwards Lifesciences, LLC | 2010-12-22 |
| ACTICON NEOSPHINCTER (P010020/S020) | Boston Scientific Corp | 2010-12-22 |
| TRUFILL N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S016) | Cerenovus, Inc. | 2010-12-22 |
| CODMAN 3000 IMPLANTABLE DRUG DELIVERY SYSTEM (P890055/S027) | Intera Oncology | 2010-12-22 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES (P860057/S073) | Edwards Lifesciences, LLC | 2010-12-22 |
| EDWARDS PRIMA PLUS PORCINE STENTLESS BIOPROSTHETIC VALVES (P010041/S025) | Edwards Lifesciences, LLC | 2010-12-22 |
| IMPLANTABLE PULSE GENERATOR (P890003/S208) | Medtronic, Inc. | 2010-12-22 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S034) | Boston Scientific Corp | 2010-12-22 |
| ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS (P840001/S169) | Medtronic Neuromodulation | 2010-12-22 |
| INTERSTIM INS (P970004/S099) | Medtronic Neuromodulation | 2010-12-22 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S009) | Hologic, Inc. | 2010-12-21 |
| PERFLUORON (P950018/S014) | Alcon Laboratories | 2010-12-21 |
| DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S103) | Medtronic Cardiac Rhythm Disease Management | 2010-12-20 |
| CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP (P890055/S026) | Intera Oncology | 2010-12-17 |
| VNS THERAPY SYSTEMS (P970003/S118) | LivaNova USA, Inc. | 2010-12-17 |
| BIOCOR AND BIOCOR SUPRA VALVES (P040021/S015) | ABBOTT MEDICAL | 2010-12-17 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010) | Medtronic Cryocath, LP | 2010-12-17 |
| LCS TOTAL KNEE SYSTEM (P830055/S116) | Depuy, Inc. | 2010-12-17 |
| QUANTIFERON-TB GOLD IN-TUBE (P010033/S016) | Qiagen | 2010-12-17 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S111) | Boston Scientific Corp | 2010-12-17 |
| AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (N970012/S084) | Boston Scientific Corp | 2010-12-16 |
| MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (EPG) (P820003/S099) | Medtronic Cardiac Rhythm Disease Management | 2010-12-16 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S033) | Boston Scientific Corp | 2010-12-16 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021) | Medtronic Vascular | 2010-12-16 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S019) | Boston Scientific Corp | 2010-12-16 |
| CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS (P030054/S175) | ABBOTT MEDICAL | 2010-12-15 |
| RELIANCE IS -1 AND RELIANCE IS-4 (P910073/S090) | Boston Scientific | 2010-12-15 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S007) | Hologic, Inc. | 2010-12-15 |
| IMPLANTABLE PULSE GENERATOR (P980035/S196) | Medtronic, Inc. | 2010-12-15 |
| ACTICON NEOSPHINCTER (P010020/S018) | Boston Scientific Corp | 2010-12-15 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S035) | Medtronic Cryocath, LP | 2010-12-15 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S082) | Boston Scientific Corp | 2010-12-15 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S015) | ABBOTT MEDICAL | 2010-12-15 |
| COCHLEAR NUCLEUS 24 IMPLANT SYSTEM (P970051/S065) | Cochlear Americas | 2010-12-15 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S032) | Boston Scientific Corp | 2010-12-15 |
| CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS (P910023/S252) | ABBOTT MEDICAL | 2010-12-15 |
| REPLY/ESPRIT (P950029/S055) | MicroPort CRM USA, Inc. | 2010-12-15 |
| AMPLATZER SEPTAL & CRIBRIFORM OCCLUDERS (P000039/S038) | ABBOTT MEDICAL | 2010-12-15 |
| AMPLATZER DUCT OCCLUDER (P020024/S030) | ABBOTT MEDICAL | 2010-12-15 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S021) | Medtimo, Inc. | 2010-12-14 |
| ESTEEM (P090018/S004) | Envoy Medical Corporation | 2010-12-14 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S087) | Advanced Bionics | 2010-12-14 |
| KAPPA 400 (P970012/S079) | Medtronic, Inc. | 2010-12-13 |
| 350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA (P980035/S195) | Medtronic, Inc. | 2010-12-13 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S019) | Siemens Healthcare Diagnostics | 2010-12-13 |
| DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (P040023/S004) | DePuy Orthopaedics, Inc. | 2010-12-13 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S014) | Siemens Healthcare Diagnostics | 2010-12-13 |
| MARQUIS/MAXIMO (P980016/S266) | Medtronic Cardiac Rhythm Disease Management | 2010-12-13 |
| DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S034) | Dexcom, Inc. | 2010-12-10 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S064) | Terumo Medical Corporation | 2010-12-10 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S043) | Medtronic, Inc. | 2010-12-10 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S028) | Roche Molecular Systems, Inc. | 2010-12-10 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S056) | W. L. Gore & Associates, Inc. | 2010-12-10 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S081) | Boston Scientific Corp | 2010-12-10 |
| IMPLANTABLE PULSE GENERATOR (P980035/S193) | Medtronic, Inc. | 2010-12-10 |
| AMPLICOR HCV/COBAS AMPLICOR HCV TEST (P000010/S018) | Roche Molecular Systems, Inc. | 2010-12-10 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S044) | Thoratec Laboratories Corp. | 2010-12-09 |
| EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S169) | ABBOTT MEDICAL | 2010-12-09 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S249) | ABBOTT MEDICAL | 2010-12-09 |
| CELLEX PROCEDURAL KIT (P860003/S056) | Therakos Development Limited | 2010-12-09 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S004) | Exactech, Inc. | 2010-12-09 |
| LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX (P050023/S040) | Biotronik, Inc. | 2010-12-08 |