| ISOMED PUMP AND INFUSION SYSTEM (P990034/S033) | Medtronic, Inc. | 2014-10-16 |
| ACTIVA FAMILY OF IMPLANTABLE DEEP BRAIN IMPLANTABLE NEUROSTIMULATORS (P960009/S207) | Medtronic, Inc. | 2014-10-16 |
| PRODIGY IPG (P890003/S323) | Medtronic, Inc. | 2014-10-16 |
| REVO MRI IPG (P090013/S161) | Medtronic, Inc. | 2014-10-16 |
| ORIGEN EL,ORIGEN MINI, INOGEN EL,INOGEN MINI, DYNAGEN EL,DYNAGEN MINI, INCEPTA, ENERGEN, PUNCTUA ICDS (P960040/S333) | Boston Scientific | 2014-10-16 |
| ADAPTA, VERA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S395) | Medtronic, Inc. | 2014-10-16 |
| DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4 ORIGEN,ORIGEN X4, INCEPTA, ENERGEN, PUNCTUA CRT-DS (P010012/S372) | Boston Scientific Corp | 2014-10-16 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S055) | Integra LifeSciences Corporation | 2014-10-16 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S055) | Integra LifeSciences Corporation | 2014-10-16 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, (P010031/S469) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S126) | Boston Scientific Scimed, Inc. | 2014-10-16 |
| RESTORE FAMILY OF IMPLANTABLE SCS NEUROSTIMULATORS (P840001/S285) | Medtronic Neuromodulation | 2014-10-16 |
| INTERSTIM THERAPY SYSTEM (P970004/S185) | Medtronic Neuromodulation | 2014-10-16 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S471) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S132) | Boston Scientific Scimed, Inc. | 2014-10-16 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S396) | Medtronic, Inc. | 2014-10-16 |
| SYNCHROMED INFUSION SYSTEN (P860004/S214) | Medtronic, Inc. | 2014-10-16 |
| REVO MRI IPG (P090013/S158) | Medtronic, Inc. | 2014-10-16 |
| ARCHITECT CORE-M (LN 6L23) (P060035/S023) | Abbott Laboratories | 2014-10-16 |
| ST. JUDE MEDICAL ADAPTER (P010032/S083) | ABBOTT MEDICAL | 2014-10-15 |
| THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL ) CATHETERS (P030031/S061) | Biosense Webster, Inc. | 2014-10-15 |
| PUREVISION (BALAFILCON A) VISABILITY TINTED CONTACT LENS (P980006/S023) | Bausch & Lomb, Inc. | 2014-10-15 |
| FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES, (P020045/S063) | Medtronic Cryocath, LP | 2014-10-15 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARDIAC (P100010/S045) | Medtronic Cryocath, LP | 2014-10-15 |
| SUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S119) | Medtronic, Inc. | 2014-10-14 |
| SPRINT QUATTRO LEAD (P920015/S143) | Medtronic, Inc. | 2014-10-14 |
| CAPSUREFIX MRI LEAD. (P090013/S157) | Medtronic, Inc. | 2014-10-14 |
| MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD (P930039/S107) | Medtronic, Inc. | 2014-10-13 |
| LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG (P980023/S061) | Biotronik, Inc. | 2014-10-10 |
| SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID) (P030050/S017) | Q-Med AB | 2014-10-10 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S050) | Medtronic | 2014-10-10 |
| EXPRESS2 CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE) (P020009/S123) | Boston Scientific Scimed, Inc. | 2014-10-10 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S007) | Medtronic, Inc. | 2014-10-10 |
| LCS TOTAL KNEE SYSTEM (P830055/S151) | Depuy, Inc. | 2014-10-10 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S129) | Boston Scientific Scimed, Inc. | 2014-10-10 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S060) | Boston Scientific Corp | 2014-10-10 |
| ALLURE FAMILY OF CRT-P'S (P030035/S125) | ABBOTT MEDICAL | 2014-10-10 |
| COROX OTW, COROX OTW-L, CELERITY (P070008/S055) | Biotronik, Inc. | 2014-10-10 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S035) | Boston Scientific Corporation | 2014-10-10 |
| PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (P110010/S085) | Boston Scientific Corp | 2014-10-10 |
| ASSURITY/ENDURITY FAMILIES OF PACEMAKERS (P880086/S247) | ABBOTT MEDICAL | 2014-10-10 |
| SELOX ST, SELOX JT, SETROX S, DEXTRUS, TILDA, SOLOX SLX, SAFIO (P950037/S140) | Biotronik, Inc. | 2014-10-10 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S032) | Boston Scientific Corporation | 2014-10-10 |
| ELLIPSE FAMILY OF ICDS (P910023/S344) | ABBOTT MEDICAL | 2014-10-10 |
| DEFLUX INJECTABLE GEL (P000029/S079) | Palette Life Sciences | 2014-10-10 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S007) | Medtronic Vascular, Inc. | 2014-10-10 |
| ON-X PROSTHETIC HEART VALVE (P000037/S038) | On-X Life Technologies, Inc. | 2014-10-10 |
| RESURE SEALANT (P130004/S005) | Ocular Therapeutix, Inc. | 2014-10-10 |
| ILESTO/IFORIA 5 & 7 ICD/CRT-D FAMILIES (P050023/S078) | Biotronik, Inc. | 2014-10-10 |
| SOLESTA INJECTABLE GEL (P100014/S016) | Palette Life Sciences | 2014-10-10 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S098) | Boston Scientific Corp | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S032) | Abbott Vascular Devices | 2014-10-10 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S204) | Boston Scientific Corp | 2014-10-09 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S026) | Dexcom, Inc. | 2014-10-09 |
| ML8 CORONARY STENT SYSTEMS (P020047/S059) | Abbott Vascular | 2014-10-09 |
| DIGENE HC2 SYSTEM SOFTWARE (P890064/S031) | Qiagen Gaithersburg, Inc. | 2014-10-09 |
| EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER (P910001/S072) | Spectranetics Corp. | 2014-10-09 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S124) | Abbott Vascular, Inc. | 2014-10-09 |
| SIR-SPHERE MICROSPHERES (P990065/S007) | Sirtex Medical, Inc. | 2014-10-09 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S205) | Boston Scientific Corp | 2014-10-09 |
| LUTONIX DRUG COATED BALLOON PTA CATETER (P130024) | Lutonix | 2014-10-09 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S008) | Abbott Vascular-Cardiac Therapies | 2014-10-09 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) AND XIENCE XPEDITION EVEROLIMUS ELUTI (P110019/S071) | Abbott Vascular | 2014-10-09 |
| SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT) (P960042/S049) | Spectranetics (Philips) | 2014-10-09 |
| IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X (P050034/S013) | Samsara Vision, Inc. | 2014-10-08 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION (P840001/S282) | Medtronic Neuromodulation | 2014-10-08 |
| MINIMED 530G INSULIN PUMP (P120010/S033) | Medtronic, Inc. | 2014-10-08 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL (P810031/S051) | Johnson & Johnson Surgical Vision, Inc. | 2014-10-08 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S045) | Medtronic Vascular | 2014-10-08 |
| LCS TOTAL KNEE SYSTEM (P830055/S149) | Depuy, Inc. | 2014-10-08 |
| FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028/S004) | Cook Medical Incorporated | 2014-10-08 |
| SYNCHROMED INFUSION SYSTEM (P860004/S212) | Medtronic, Inc. | 2014-10-08 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S160) | Medtronic Minimed | 2014-10-08 |
| INTERSTIM THERAPY SYSTEM (P970004/S183) | Medtronic Neuromodulation | 2014-10-08 |
| INTERSTIM THERAPY SYSTEM (P080025/S079) | Medtronic Neuromodulation | 2014-10-08 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S205) | Medtronic, Inc. | 2014-10-08 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S002) | Cardiva Medical, Inc. | 2014-10-07 |
| ST.JUDE MEDICAL MECHANICAL HEART VALVE, SJM MASTER SERIES MECHANICAL HEART VALVESJM REGENT MECHANICAL HEART VALVE, (P810002/S090) | ABBOTT MEDICAL | 2014-10-07 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S002) | Scott Laboratories, Inc. | 2014-10-07 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S028) | Medtimo, Inc. | 2014-10-07 |
| TUNNELIING TOOL (P920015/S142) | Medtronic, Inc. | 2014-10-07 |
| THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES (P060010/S012) | Srs Medical | 2014-10-06 |
| TRIPOLE 16 & 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44 & LAMITRODE 44C LEADS, LAMITRODE 88 LEAD, LAMITRODE S-4 (P010032/S084) | ABBOTT MEDICAL | 2014-10-06 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S060) | Hologic, Inc. | 2014-10-06 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S122) | Abbott Vascular, Inc. | 2014-10-03 |
| INTERSTIM THERAPY SYSTEM (P080025/S080) | Medtronic Neuromodulation | 2014-10-03 |
| ENDURANT AND ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM (P100021/S040) | Medtronic Vascular | 2014-10-03 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S504) | Medtronic Cardiac Rhythm Disease Management | 2014-10-03 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD (P840001/S283) | Medtronic Neuromodulation | 2014-10-03 |
| INTERSTIM THERAPY SYSTEM (P970004/S184) | Medtronic Neuromodulation | 2014-10-03 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S012) | Abbott Vascular, Inc. | 2014-10-03 |
| SYNCHROMED INFUSION SYSTEM (P860004/S213) | Medtronic, Inc. | 2014-10-03 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S206) | Medtronic, Inc. | 2014-10-03 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S468) | Medtronic Cardiac Rhythm Disease Management | 2014-10-03 |
| XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S066) | Abbott Vascular | 2014-10-03 |
| SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS (N16895/S096) | Bausch & Lomb, Inc. | 2014-10-02 |
| MINILINK REAL-TIME TRANSMITTER, IPRO2 RECORDER (P980022/S156) | Medtronic Minimed | 2014-10-02 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S018) | LeMaitre Vascular, Inc. | 2014-10-02 |
| CARPENTIER-EDWARDS PERIMOUNT MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS (P860057/S128) | Edwards Lifesciences, LLC | 2014-10-02 |