| INJEX ANCHOR KITS AND VECTRIS SURESCAN MRI LEAD KITS (P840001/S278) | Medtronic Neuromodulation | 2014-08-19 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S002) | Boston Scientific Corp | 2014-08-19 |
| RADIESSE 0.8 CC, RADIESSE 1.5CC, RADIESSE 3.0CC (P050037/S052) | Merz North America, Inc. | 2014-08-19 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S057) | Cordis US Corporation | 2014-08-18 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA (P010031/S456) | Medtronic Cardiac Rhythm Disease Management | 2014-08-15 |
| ADVISA DR IPG, DR MRI IPG, ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S387) | Medtronic, Inc. | 2014-08-15 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S013) | Abbott Vascular, Inc. | 2014-08-15 |
| ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1 (P010012/S365) | Boston Scientific Corp | 2014-08-15 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S014) | LeMaitre Vascular, Inc. | 2014-08-15 |
| ACUITY STEERABLE (P050046/S024) | Guidant Corp. | 2014-08-15 |
| EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD (P980016/S493) | Medtronic Cardiac Rhythm Disease Management | 2014-08-15 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S043) | Medtronic Heart Valves | 2014-08-14 |
| ZILVER VASCULAR STENT (P050017/S010) | Cook Ireland, Ltd. | 2014-08-14 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S049) | Medtronic, Inc. | 2014-08-14 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S030) | Zimmer, Inc. | 2014-08-14 |
| SYNCHROMED INFUSION SYSTEM (P860004/S210) | Medtronic, Inc. | 2014-08-14 |
| VISTAKON SENOFILCON A BRAND CONTACT LENSES (P040045/S046) | Vistakon, Division of Johnson & Johnson Vision Car | 2014-08-14 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S008) | Abbott Molecular, Inc. | 2014-08-14 |
| SPRINT QUATTRO LEAD (P920015/S137) | Medtronic, Inc. | 2014-08-14 |
| CAPSUREFIX LEAD, SUREFIX LEAD (P930039/S114) | Medtronic, Inc. | 2014-08-14 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S047) | Medtronic, Inc. | 2014-08-14 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S027) | Medtronic, Inc. | 2014-08-14 |
| VISTAKON ETAFILCON A BRAND CONTACT LENSES (N18033/S074) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2014-08-14 |
| MOSIAC PORCINE BIOPOROSTHESIS (P990064/S058) | Medtronic, Inc. | 2014-08-14 |
| UROVYSION BLADDER CANCER KIT (P030052/S016) | Abbott Molecular | 2014-08-14 |
| REVO MRI IPG (P090013/S151) | Medtronic, Inc. | 2014-08-13 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S037) | Coloplast Corp. | 2014-08-13 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S034) | Bard Peripheral Vascular | 2014-08-13 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S385) | Medtronic, Inc. | 2014-08-13 |
| NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S (P010012/S366) | Boston Scientific Corp | 2014-08-13 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S007) | ABBOTT MEDICAL | 2014-08-13 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S246) | Medtronic, Inc. | 2014-08-13 |
| EVERA S DR ICD, EVERA S VR ICS, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D (P980016/S495) | Medtronic Cardiac Rhythm Disease Management | 2014-08-13 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG,RELIA IPG (P980035/S388) | Medtronic, Inc. | 2014-08-13 |
| NG3 DEVICES: ORIGEN, INOGEN, DYNAGEN ICDS; PROGENY DEVICES: PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD (P960040/S326) | Boston Scientific | 2014-08-13 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S048) | Medtronic | 2014-08-13 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA (P010031/S459) | Medtronic Cardiac Rhythm Disease Management | 2014-08-13 |
| BVI 1% OVD (P960011/S026) | Altacor , Ltd. | 2014-08-12 |
| MEDTRONIC COREVALVE SYSTEM AND TRANSCATHETER AORTIC VALVE (P130021/S005) | Medtronic, Inc. | 2014-08-12 |
| BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D (P010031/S458) | Medtronic Cardiac Rhythm Disease Management | 2014-08-12 |
| CAP SURE VDD-2 LEAD, VITATRON BRILLIANT S+ VDD LEAD (P890003/S312) | Medtronic, Inc. | 2014-08-12 |
| SEPRAFILM ADHESION BARRIER (P950034/S042) | Baxter Healthcare Corporation | 2014-08-12 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S060) | Medtronic, Inc. | 2014-08-12 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S093) | MicroPort CRM USA, Inc. | 2014-08-12 |
| BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S025) | Smith & Nephew, Inc. | 2014-08-12 |
| AFX VELA PROXIMAL ENDOGRAFT SYSTEM (P040002/S053) | Endologix, LLC | 2014-08-12 |
| CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD, CAPSURE SP NOVUS LEAD (P850089/S108) | Medtronic Cardiac Rhythm Disease Management | 2014-08-12 |
| CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S111) | Medtronic Cardiac Rhythm Disease Management | 2014-08-12 |
| SPECTRUM BREAST IMPLANTS (P990075/S026) | Mentor Worldwide, LLC | 2014-08-12 |
| VENTAK PRX AND VENTAK MINI SYSTEMS (P910077/S144) | Boston Scientific | 2014-08-12 |
| COLOGUARD (P130017) | Exact Sciences Corporation | 2014-08-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S126) | Edwards Lifesciences, LLC | 2014-08-11 |
| VERTICALLY INTEGRATING BATTERY FEEDTHRU ASSEMBLY (P960040/S325) | Boston Scientific | 2014-08-11 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES (P060037/S021) | Zimmer, Inc. | 2014-08-11 |
| CAPSUREFIX MRI LEAD (P090013/S148) | Medtronic, Inc. | 2014-08-08 |
| ITREL TOTALLY IMPLANTABLE SPINAL CORD STIMULATOR SYSTEM (P840001/S277) | Medtronic Neuromodulation | 2014-08-08 |
| SPRINT QUATTRO LEAD (P920015/S135) | Medtronic, Inc. | 2014-08-08 |
| LCS TOTAL KNEE SYSTEM (P830055/S146) | Depuy, Inc. | 2014-08-08 |
| CAPSURE SENSE LEAD (P830061/S110) | Medtronic Cardiac Rhythm Disease Management | 2014-08-08 |
| CAPSUREFIX NOVUS LEAD (P930039/S112) | Medtronic, Inc. | 2014-08-08 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S003) | Cardiva Medical, Inc. | 2014-08-07 |
| RESTYLANE-PERLANE-RESTYLANE-L/PERLANE-L AND RESTYLANE-SILK INJECTABLE GELS (P040024/S077) | Q-Med AB | 2014-08-07 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S005) | Edwards Lifesciences, LLC | 2014-08-07 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C (P020045/S057) | Medtronic Cryocath, LP | 2014-08-07 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S003) | Edwards Lifesciences, LLC | 2014-08-07 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S039) | Medtronic Cryocath, LP | 2014-08-07 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S026) | Syncardia Systems, LLC | 2014-08-07 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C(PDD) SYSTEM -D-LIGHT C LIGHT SOURCE (P050027/S006) | KARL STORZ Endoscopy-America, Inc. | 2014-08-07 |
| SOLESTA INJECTABLE GEL (P100014/S015) | Palette Life Sciences | 2014-08-07 |
| LIFEVEST DEVICE (P010030/S055) | Zoll Manufacturing Corporation | 2014-08-07 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S029) | Ventana Medical Systems, Inc. | 2014-08-06 |
| PREVELLE SILK (P030032/S016) | Genzyme Biosurgery | 2014-08-06 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S198) | Boston Scientific Corp | 2014-08-06 |
| SYNVISC AND SYNVISC ONE (P940015/S029) | Sanofi Genzyme Corp. | 2014-08-06 |
| PROMUS ELEMENT PLUS/ PREMIER EVEROLIMUS- ELUTING PLATINUN CHROMIUM CORONARY STENT SYSTEM (P110010/S091) | Boston Scientific Corp | 2014-08-05 |
| ION PACLITITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S103) | Boston Scientific Corp | 2014-08-05 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS) (P060040/S031) | ABBOTT MEDICAL | 2014-08-05 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S054) | Edwards Lifesciences, LLC | 2014-08-04 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S001) | Edwards Lifesciences, LLC | 2014-08-04 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S001) | Boston Scientific Corp | 2014-08-04 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 LEADS (P060039/S056) | Medtronic, Inc. | 2014-08-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S118) | Edwards Lifesciences, LLC | 2014-08-04 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S041) | Edwards Lifesciences, LLC | 2014-08-04 |
| RESTOREULTRA RECHARGEABLE NEUROSTIMULATOR, RESTOREADVANCED RECHARGEABLE NEUROSTIMULATOR, RESTOREULTRA SURESCAN MRI (P840001/S275) | Medtronic Neuromodulation | 2014-08-01 |
| ELLIPSE FAMILY OF ICDS (P910023/S339) | ABBOTT MEDICAL | 2014-08-01 |
| EN VISTA ONE PIECE HYDROPHOBIC ACRYLIC LENS (P910056/S017) | Bausch & Lomb, Inc. | 2014-08-01 |
| NAVISTAR THERMOCOOL (P040036/S043) | Biosense Webster, Inc. | 2014-08-01 |
| ACTIVA (P960009/S199) | Medtronic, Inc. | 2014-08-01 |
| NIT-OCCLUD PDA (P120009/S001) | Pfm Medical, Inc. | 2014-08-01 |
| ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD (P080006/S068) | Medtronic, Inc. | 2014-08-01 |
| INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP (P800036/S038) | Intera Oncology | 2014-08-01 |
| ACTIVA RC RECHARGEABLE NEUROSTIMULATOR (P960009/S198) | Medtronic, Inc. | 2014-08-01 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S142) | Boston Scientific Corp | 2014-08-01 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR CONSOLE AND FOOT PEDAL) (P900056/S132) | Boston Scientific Corp | 2014-08-01 |
| RESTORE (P840001/S276) | Medtronic Neuromodulation | 2014-08-01 |
| INTERSTIM (P970004/S180) | Medtronic Neuromodulation | 2014-08-01 |
| INTERSTIM (P080025/S076) | Medtronic Neuromodulation | 2014-08-01 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S043) | Medtronic Vascular | 2014-07-31 |
| PRODISC-L (P050010/S013) | Centinel Spine, LLC | 2014-07-31 |
| DEFLUX INJECTABLE GEL (P000029/S078) | Palette Life Sciences | 2014-07-31 |