| MINIMED 530G INSULIN PUMP (P120010/S006) | Medtronic, Inc. | 2013-12-05 |
| LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR, O2 OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM,AIR OPTIX AQUA (P010019/S036) | Alcon Laboratories, Inc. | 2013-12-05 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P920047/S063) | Boston Scientific Corp | 2013-12-05 |
| ACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS (P880086/S236) | ABBOTT MEDICAL | 2013-12-04 |
| WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S049) | Boston Scientific Corp | 2013-12-04 |
| ANTHEM & ANTHEM RF CRT-P'S (P030035/S114) | ABBOTT MEDICAL | 2013-12-04 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S182) | Boston Scientific Corp | 2013-12-04 |
| WALLSTENT (VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S038) | Boston Scientific Corporation | 2013-12-04 |
| FINELINE II STEROX (P960004/S064) | Boston Scientific | 2013-12-04 |
| STRATOS LV AND LV-T CRT-P'S (P070008/S048) | Biotronik, Inc. | 2013-12-03 |
| LUMAX FAMILIES OF ICD'S (P050023/S070) | Biotronik, Inc. | 2013-12-03 |
| CERVISTA HPV HR (P080014/S020) | Hologic, Inc. | 2013-12-03 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S- ICD SYSTEM (P110042/S021) | Boston Scientific Corporation | 2013-12-03 |
| INTELLA TIP MIFI XP ABLATION CATHETER (P020025/S050) | Boston Scientific | 2013-12-03 |
| CERVISTA HPV 16/18 (P080015/S011) | Hologic, Inc. | 2013-12-03 |
| LUMAX FAMILIES OF ICD'S & CRT-D'S (P050023/S071) | Biotronik, Inc. | 2013-12-03 |
| EVIA FAMILY OF PACEMAKERS (P950037/S130) | Biotronik, Inc. | 2013-12-03 |
| EVIA FAMILY OF PACEMAKERS (P950037/S129) | Biotronik, Inc. | 2013-12-03 |
| TRI VASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM; TRI VASCULAR, INC OVATION PRIME ABDOMINAL ABDOMINAL STENT GRAFT (P120006/S008) | Endologix, LLC | 2013-12-02 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S014) | Boston Scientific Corp | 2013-12-02 |
| M-VU ALGORITHM ENGINE (P100005/S003) | Icad, Inc. | 2013-12-02 |
| COLLACOTE,COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S025) | Integra Lifesciences Corp. | 2013-11-29 |
| HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S033) | Integra LifeSciences Corporation | 2013-11-29 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S027) | Integra Lifesciences Corp. | 2013-11-29 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S036) | Integra LifeSciences Corporation | 2013-11-29 |
| LSC TOTAL KNEE SYSTEM (P830055/S129) | Depuy, Inc. | 2013-11-29 |
| RADIESSE DERMAL FILLER (P050052/S046) | Merz North America, Inc. | 2013-11-27 |
| THE PATH VYSION HER-2 DNA PRODE KIT (P980024/S011) | Abbott Molecular, Inc. | 2013-11-27 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S005) | Abbott Molecular, Inc. | 2013-11-27 |
| VARIOUS FAMILIES OF SPINAL CORD STIMULATION SYSTEMS (P840001/S256) | Medtronic Neuromodulation | 2013-11-27 |
| RADIESSE DERMAL FILLER (P050037/S043) | Merz North America, Inc. | 2013-11-27 |
| URO VYSION BLADDER CANCER KIT (P030052/S013) | Abbott Molecular | 2013-11-27 |
| MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEMS (P970020/S077) | Abbott Vascular, Inc. | 2013-11-26 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S054) | Medtronic, Inc. | 2013-11-26 |
| ATTAIN BIPOLAR OTW LEAD , LEAD VENTRICULAR PACING LEAD (P010015/S226) | Medtronic, Inc. | 2013-11-26 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S085) | MicroPort CRM USA, Inc. | 2013-11-26 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S019) | Boston Scientific Corporation | 2013-11-26 |
| EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES (P110021/S029) | Edwards Lifesciences, LLC | 2013-11-26 |
| ARCHITECT AFP (P120008/S005) | Abbott Laboratories | 2013-11-26 |
| VNS THERAPY SYSTEM (P970003/S146) | LivaNova USA, Inc. | 2013-11-26 |
| CELSIUS FLTR CATHETERS (P010068/S037) | Biosense Webster, Inc. | 2013-11-26 |
| HERCEPTEST (P980018/S018) | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-11-26 |
| ARCHITECT CORE (P080023/S023) | Abbott Laboratories | 2013-11-26 |
| CAPSURE FIX MRI LEAD (P090013/S120) | Medtronic, Inc. | 2013-11-26 |
| COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS (P010012/S342) | Boston Scientific Corp | 2013-11-26 |
| INVIVE,INTUA CRT-PS (P030005/S104) | Guidant Corp. | 2013-11-26 |
| Y ADAPTOR EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CIONNECTIR PORT PIN PLUG, LEAD ADAPTOR, SPRINT QUATTRO LEAD (P920015/S123) | Medtronic, Inc. | 2013-11-26 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S014) | Abbott Laboratories | 2013-11-26 |
| BIOSENSE WEBSTER CELSIUS FLTR CATHETER (P950005/S048) | Biosense Webster, Inc. | 2013-11-26 |
| FORMIO,VITALIO,ADVANTIO,INGENIO,ALTRUA,INSIGNIA PACEMAKERS (N970003/S157) | Boston Scientific Corp | 2013-11-26 |
| ATTAIN STARFIX LEAD (P060039/S053) | Medtronic, Inc. | 2013-11-26 |
| UNIFY AND UNIFY QUADRA CRT-D'S (P030054/S253) | ABBOTT MEDICAL | 2013-11-26 |
| CAPSURE LEAD, SERVICE KIT PACEMAKER REPAIR KIT (P890003/S291) | Medtronic, Inc. | 2013-11-26 |
| ARCHITECT FREE PSA (P980007/S031) | Abbott Laboratories | 2013-11-26 |
| FORTIFY VR/DR ICD'S (P910023/S322) | ABBOTT MEDICAL | 2013-11-26 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S031) | Allergan | 2013-11-26 |
| ARCHITECT CORE (P080023/S024) | Abbott Laboratories | 2013-11-26 |
| PARADYM VR/DR 8750, PARADYM RF VR/RF DR 9750 (P980049/S089) | MicroPort CRM USA, Inc. | 2013-11-26 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+LEAD (P830061/S100) | Medtronic Cardiac Rhythm Disease Management | 2013-11-26 |
| ARCHITECT TOTAL PSA (P910007/S040) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT ANTI-HCV (P050042/S028) | Abbott Laboratories, Inc. | 2013-11-26 |
| ARCHITECT TOTAL PSA (P910007/S041) | Abbott Laboratories | 2013-11-26 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATION IMPULSE II LEAD (P850089/S103) | Medtronic Cardiac Rhythm Disease Management | 2013-11-26 |
| CAPSUREFIX LEAD CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD (P930039/S096) | Medtronic, Inc. | 2013-11-26 |
| ACH HEADER, END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE (P900061/S124) | Medtronic Cardiac Rhythm Disease Management | 2013-11-26 |
| PUNCTUA,TELIGEN,ENERGEN,INCEPTA,VITALITY ICDS (P960040/S307) | Boston Scientific | 2013-11-26 |
| ARCHITECT AUSAB (P050051/S023) | Abbott Laboratories, Inc. | 2013-11-26 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S016) | Abbott Laboratories | 2013-11-26 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S012) | Roche Molecular Systems, Inc. | 2013-11-26 |
| ATTAIN ABILITY LEAD (P080006/S060) | Medtronic, Inc. | 2013-11-26 |
| ARCHITECT HBSAG QUAL/CONF (P110029/S015) | Abbott Laboratories | 2013-11-26 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S042) | Edwards Lifesciences, LLC | 2013-11-26 |
| ARCHITECT AFP (P120008/S004) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT AUSAB (P050051/S024) | Abbott Laboratories, Inc. | 2013-11-26 |
| ARCHITECT CORE-M (P060035/S021) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT ANTI-HCV (P050042/S027) | Abbott Laboratories, Inc. | 2013-11-26 |
| ARCHITECT FREE PSA (P980007/S032) | Abbott Laboratories | 2013-11-26 |
| ARCHITECT CORE-M (P060035/S022) | Abbott Laboratories | 2013-11-26 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S114) | Edwards Lifesciences, LLC | 2013-11-26 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (P060027/S057) | MicroPort CRM USA, Inc. | 2013-11-26 |
| TRANSVENE CS/SVC LEAD (P980050/S087) | Medtronic, Inc. | 2013-11-26 |
| LEAD ANCHORING SLEEVE KIT; SELECT SECURE LEAD (P030036/S066) | Medtronic Cardiac Rhythm Disease Management | 2013-11-26 |
| WAVELIGHT EX500 EXCIMER LASER SYSTEM (P020050/S010) | Alcon Laboratories, Inc. | 2013-11-25 |
| EPT-1000 XP RF ABLATION SYSTEM (P020025/S046) | Boston Scientific | 2013-11-25 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S088) | W. L. Gore & Associates, Inc. | 2013-11-25 |
| WAVELIGHT EX500 EXCIMER LASER SYSTEM (P030008/S009) | Alcon Laboratories, Inc. | 2013-11-25 |
| ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES (P100030/S001) | Baxter Healthcare Corporation | 2013-11-25 |
| HELEX SEPTAL OCCLUDER (P050006/S037) | W. L. Gore & Associates, Inc. | 2013-11-25 |
| VIABAHN ENDOPROSTHESIS (P040037/S059) | W. L. Gore & Associates, Inc. | 2013-11-25 |
| TAG THORACIC ENDOPROSTHESIS (P040043/S059) | W. L. Gore & Associates, Inc. | 2013-11-25 |
| EPT-1000 XP RF ABLATION SYSTEM (P020025/S045) | Boston Scientific | 2013-11-25 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S058) | W. L. Gore & Associates, Inc. | 2013-11-24 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S001) | Medtronic Vascular | 2013-11-24 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S023) | Boston Scientific Corp | 2013-11-24 |
| ACTIVA PC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR, (P960009/S185) | Medtronic, Inc. | 2013-11-22 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS (P010031/S402) | Medtronic Cardiac Rhythm Disease Management | 2013-11-22 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S018) | Corcym Canada Corp | 2013-11-22 |
| SILIKON 1000 RETINAL TAMPONADE (P950008/S011) | Alcon | 2013-11-22 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S441) | Medtronic Cardiac Rhythm Disease Management | 2013-11-22 |
| TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES (P920015/S117) | Medtronic, Inc. | 2013-11-22 |