| INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P080025/S060) | Medtronic Neuromodulation | 2013-11-22 |
| 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) (P890057/S021) | ZOLL Medical Corporation | 2013-11-22 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P970004/S164) | Medtronic Neuromodulation | 2013-11-22 |
| CARELINK HOME MONITOR,CARDIOSIGHT READER,CARELINK NETWORK DEVICE DATA MANAGEMENT APPLICATION (P890003/S292) | Medtronic, Inc. | 2013-11-22 |
| ITREL 4 IMPLANTABLE NEUROSTIMULATOR,ITREL 4 IMPLANTABLE NEUROSTIMULATOR,ITREL 3 IMPLANTABLE NEUROSTIMULATOR,RESTOREPRIME (P840001/S255) | Medtronic Neuromodulation | 2013-11-22 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM (P110032/S006) | Lombard Medical Limited | 2013-11-21 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S053) | Boston Scientific Corp | 2013-11-21 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S352) | Medtronic, Inc. | 2013-11-21 |
| COAPTITE INJECTABLE IMPLANT (P040047/S030) | Merz North America, Inc. | 2013-11-21 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S016) | DePuy Orthopaedics, Inc. | 2013-11-21 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S018) | Boston Scientific Corporation | 2013-11-21 |
| SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY (P840001/S254) | Medtronic Neuromodulation | 2013-11-20 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S057) | Abbott Vascular | 2013-11-20 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S116) | Abbott Vascular, Inc. | 2013-11-20 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S053) | Medtronic, Inc. | 2013-11-19 |
| ATTAIN STARFIX LEAD (P060039/S052) | Medtronic, Inc. | 2013-11-19 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,TORQUE CLIP DEVICE - ACCESSORY FOR 5076 LEAD (P930039/S095) | Medtronic, Inc. | 2013-11-19 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S406) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| ATTAIN STARFIX LV LEAD (P060039/S049) | Medtronic, Inc. | 2013-11-19 |
| REVO MRI IPG (P090013/S118) | Medtronic, Inc. | 2013-11-19 |
| CAPSURE SENSE LEAD, CAPSURE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S099) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| ATTAIN ABILITY LEAD (P080006/S059) | Medtronic, Inc. | 2013-11-19 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S121) | Medtronic, Inc. | 2013-11-19 |
| VARIOUS MODELS OF PASYS, SPECTRAX, SYMBIOS, SYNERGYST (P820003/S125) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| ABBOTT REAL TIME HBV CALIBRATOR KIT (P100017/S008) | Abbott Molecular, Inc. | 2013-11-19 |
| ABBOTT REAL TIME HBV CONTROL KIT (P080026/S010) | Abbott Molecular, Inc. | 2013-11-19 |
| EPICARDIAL PATCH LEAD (P900061/S123) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| ADVISA DR IPG; ADVISA DR MRI IPG (P980035/S353) | Medtronic, Inc. | 2013-11-19 |
| CONSULTA CRT-P ; SYNCRA CRT-P (P010015/S224) | Medtronic, Inc. | 2013-11-19 |
| TRANSVENE CS/SVC LEAD (P980050/S086) | Medtronic, Inc. | 2013-11-19 |
| SELECTSECURE LEAD (P030036/S065) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S351) | Medtronic, Inc. | 2013-11-19 |
| CAPSURE LEAD (P890003/S289) | Medtronic, Inc. | 2013-11-19 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S445) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P (P010015/S225) | Medtronic, Inc. | 2013-11-19 |
| CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD (P850089/S102) | Medtronic Cardiac Rhythm Disease Management | 2013-11-19 |
| CAPSUREFIX MRI LEAD,REVO MRI IPG (P090013/S119) | Medtronic, Inc. | 2013-11-19 |
| ADAPTA,VERSA,SENSIA IPGS (P980035/S354) | Medtronic, Inc. | 2013-11-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S030) | Edwards Lifesciences, LLC | 2013-11-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S043) | Edwards Lifesciences, LLC | 2013-11-18 |
| ARCHITECT ANTI-HCV ASSAY, LN IL79 (P050042/S026) | Abbott Laboratories, Inc. | 2013-11-15 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S009) | Integra LifeSciences Corporation | 2013-11-15 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S025) | Stryker Corp. | 2013-11-15 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S023) | Ventana Medical Systems, Inc. | 2013-11-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S024) | Medtronic | 2013-11-15 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S025) | Medtronic | 2013-11-15 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S021) | Integra LifeSciences Corporation | 2013-11-15 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S011) | Ventana Medical Systems, Inc. | 2013-11-15 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S012) | Ventana Medical Systems, Inc. | 2013-11-15 |
| NEUROPACE RNS SYSTEM (P100026) | NeuroPace, Inc. | 2013-11-14 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S024) | Medtronic, Inc. | 2013-11-14 |
| ON-X PROSTHETICHEART VALVE (P000037/S033) | On-X Life Technologies, Inc. | 2013-11-14 |
| MULTI-LINK ZETA RX CORONARY STENT SYSTEM (P970020/S078) | Abbott Vascular, Inc. | 2013-11-14 |
| VISION RX, MINI VISION RX,MULTILINK 8 CORONARY STENT SYSTEM(CSS) (P020047/S056) | Abbott Vascular | 2013-11-14 |
| XIENCE PRIME EECSS(XIENCE PRIME AND XIENCE PRIME LONG LENGTHS) (P110019/S056) | Abbott Vascular | 2013-11-14 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S350) | Medtronic, Inc. | 2013-11-14 |
| 1258T AND 1458Q FAMILY OF LEADS (P030054/S246) | ABBOTT MEDICAL | 2013-11-14 |
| REVO MRI IPG (P090013/S116) | Medtronic, Inc. | 2013-11-14 |
| REVO MRI IPG (P090013/S117) | Medtronic, Inc. | 2013-11-14 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S223) | Medtronic, Inc. | 2013-11-14 |
| ADVISA DR MRI IPG (P980035/S349) | Medtronic, Inc. | 2013-11-14 |
| HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT (P790007/S040) | Medtronic Heart Valves | 2013-11-14 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) AND XIENCE NANO EECSS (P070015/S115) | Abbott Vascular, Inc. | 2013-11-14 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S107) | Cochlear Americas | 2013-11-13 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S042) | Alcon Research, Ltd. | 2013-11-13 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S028) | Neomend, Inc. | 2013-11-08 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S050) | Hologic, Inc. | 2013-11-08 |
| AMPLATZER DUCT OCCLUDER II (P020024/S040) | ABBOTT MEDICAL | 2013-11-08 |
| RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM,RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM (P110013/S015) | Medtronic Vascular | 2013-11-07 |
| TRIFECTA VALVE (P100029/S016) | ABBOTT MEDICAL | 2013-11-07 |
| BIOCOR/EPIC VALVE (P040021/S024) | ABBOTT MEDICAL | 2013-11-07 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S001) | Gen-Probe Incorporated | 2013-11-06 |
| ARTERX SURGICAL SEALANT, (P100030/S002) | Baxter Healthcare Corporation | 2013-11-05 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X (P050034/S009) | Samsara Vision, Inc. | 2013-11-05 |
| ESTEEM (P090018/S024) | Envoy Medical Corporation | 2013-11-04 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM (P110032/S001) | Lombard Medical Limited | 2013-11-01 |
| PARADIGM REAL TIME PUMP & PARADIGM REAL TIME REVEL INSULIN PUMP (P980022/S138) | Medtronic Minimed | 2013-10-31 |
| SUBCUTANEOUS IMPLANABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S016) | Boston Scientific Corporation | 2013-10-31 |
| EVERA S DR ICD. EVERA S VR ICD, EVERA XT DR ICD; EVERA XT VR ICD, PROTECTA ICD, PROCTECTA XT ICD (P980016/S435) | Medtronic Cardiac Rhythm Disease Management | 2013-10-31 |
| BRAVA CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA S CRT-D, VIVA XT CRT-D (P010031/S396) | Medtronic Cardiac Rhythm Disease Management | 2013-10-31 |
| INTERSTIM II NEUROSTIMULATOR (P080025/S059) | Medtronic Neuromodulation | 2013-10-30 |
| DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S184) | Medtronic, Inc. | 2013-10-30 |
| DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY (P860004/S199) | Medtronic, Inc. | 2013-10-30 |
| SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY (P840001/S253) | Medtronic Neuromodulation | 2013-10-30 |
| ESSURE (P020014/S040) | Bayer Pharma AG | 2013-10-30 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S031) | Medtronic | 2013-10-30 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S163) | Medtronic Neuromodulation | 2013-10-30 |
| PARADYM VR 8750, PARADYM DR8750 (P980049/S088) | MicroPort CRM USA, Inc. | 2013-10-29 |
| SPRINT QUATTRO ELECTRODE RING SUPPLIER MATERIAL STOCK CHANGE (P920015/S120) | Medtronic, Inc. | 2013-10-29 |
| PARADYM CRT-D 8750 (P060027/S056) | MicroPort CRM USA, Inc. | 2013-10-29 |
| BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P010031/S398) | Medtronic Cardiac Rhythm Disease Management | 2013-10-29 |
| EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD (P980016/S437) | Medtronic Cardiac Rhythm Disease Management | 2013-10-29 |
| ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) (P050011/S005) | Baxter Healthcare Corp | 2013-10-29 |
| LCS TOTAL KNEE SYSTEM (P830055/S139) | Depuy, Inc. | 2013-10-29 |
| XACT CAROTID STENT SYSTEM (P040038/S030) | Abbott Vascular, Inc. | 2013-10-28 |
| SYNCHROMED II DRUG INFUSION PUMP (P860004/S200) | Medtronic, Inc. | 2013-10-28 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S055) | Abbott Vascular | 2013-10-28 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S114) | Abbott Vascular, Inc. | 2013-10-28 |
| XIENCE PRIME AND XIENCE PRINCE LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S054) | Abbott Vascular | 2013-10-28 |
| RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS (P040024/S071) | Q-Med AB | 2013-10-25 |