| PRECISE NITINOL STENT SYSTEMS (P030047/S028) | Cordis US Corporation | 2015-04-16 |
| PROGENSA PCA3 ASSAY (P100033/S003) | Gen-Probe Incorporated | 2015-04-16 |
| MINIMED 530G INSULIN PUMPS (P120010/S065) | Medtronic, Inc. | 2015-04-16 |
| THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S079) | Therakos Development Limited | 2015-04-16 |
| INTRASTENT DOUBLESTRUT STENT (P030045/S002) | Medtronic Vascular, Inc. | 2015-04-16 |
| SMART CONTROL VASCULAR STENT SYSTEM (P120002/S008) | Cordis US Corporation | 2015-04-16 |
| CARPENTER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE FAMILIES (P860057/S134) | Edwards Lifesciences, LLC | 2015-04-16 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S062) | Integra LifeSciences Corporation | 2015-04-16 |
| AMS 800 URINARY CONTROL SPHINCTER (P000053/S058) | Boston Scientific Corp | 2015-04-15 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S036) | CooperVision, Inc. | 2015-04-15 |
| AMS ACTICON NEOSPHINCTER (P010020/S031) | Boston Scientific Corp | 2015-04-15 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S026) | Mentor Corp. | 2015-04-15 |
| AMS 700 INFLATABLE PENILE PROSTHESIS,AMS AMBICOR PENILE PROSTHESIS (N970012/S107) | Boston Scientific Corp | 2015-04-15 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEE (P060037/S035) | Zimmer, Inc. | 2015-04-15 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S062) | Integra LifeSciences Corporation | 2015-04-14 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S220) | Boston Scientific Corp | 2015-04-14 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S109) | Advanced Bionics | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S061) | Integra LifeSciences Corporation | 2015-04-14 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S045) | Integra Lifesciences Corp. | 2015-04-14 |
| ANIMAS VIBE SYSTEM (P130007/S001) | Animas Corp. | 2015-04-14 |
| COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSINGS (P840062/S046) | Integra Lifesciences Corp. | 2015-04-14 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S269) | Medtronic, Inc. | 2015-04-13 |
| EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS (P100016/S002) | Carl Zeiss Meditec Production, LLC | 2015-04-13 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S106) | Boston Scientific Corp | 2015-04-13 |
| ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS (P040020/S050) | Alcon Research, Ltd. | 2015-04-13 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S040) | Coloplast Corp. | 2015-04-13 |
| INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S005) | GE Healthcare | 2015-04-13 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S032) | Edwards Lifesciences, LLC | 2015-04-13 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S417) | Medtronic, Inc. | 2015-04-13 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| REVO MRI IPG (P090013/S181) | Medtronic, Inc. | 2015-04-13 |
| HYDRELLE (P050033/S019) | Anika Therapeutics, Inc. | 2015-04-10 |
| VNS THERAPY SYSTEM PROGRAMMING SOFTWARE (P970003/S177) | LivaNova USA, Inc. | 2015-04-10 |
| CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD (P830061/S119) | Medtronic Cardiac Rhythm Disease Management | 2015-04-10 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S218) | Boston Scientific Corp | 2015-04-10 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S219) | Boston Scientific Corp | 2015-04-10 |
| VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S059) | Alcon Laboratories | 2015-04-10 |
| LIVEWIRE TC ABLATION CATHETER (P960016/S046) | St Jude Medical | 2015-04-09 |
| THERAPY DUAL 8 CATHETER (P040042/S028) | Irvine Biomedical,Inc.(Ibi) | 2015-04-09 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S013) | Cardiva Medical, Inc. | 2015-04-09 |
| REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES (P810002/S096) | ABBOTT MEDICAL | 2015-04-09 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, CONAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S045) | Roche Molecular Systems, Inc. | 2015-04-09 |
| THERAPY CATHETER (P040014/S023) | Irvine Biomedical, Inc. | 2015-04-09 |
| RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES (P060011/S006) | Rayner Intraocular Lenses , Ltd. | 2015-04-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S046) | Roche Molecular Systems, Inc. | 2015-04-09 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S020) | Roche Molecular Systems, Inc. | 2015-04-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S052) | Zoll Manufacturing Corporation | 2015-04-09 |
| TRULIGN TORIC WEB-BASED TORIC CALCULATOR (P030002/S033) | Bausch & Lomb, Inc. | 2015-04-09 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S011) | Boston Scientific Corp | 2015-04-09 |
| COBAS EGFR MUTATION TEST (P120019/S006) | Roche | 2015-04-09 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S038) | Boston Scientific Corporation | 2015-04-09 |
| IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T (P050023/S083) | Biotronik, Inc. | 2015-04-09 |
| COBAS HPV TEST (P100020/S014) | Roche Molecular Systems, Inc. | 2015-04-09 |
| STATOS LV/LV-T, EVIA/ENTOVIS HF/HF-T (P070008/S060) | Biotronik, Inc. | 2015-04-09 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S013) | Roche Molecular Systems, Inc. | 2015-04-09 |
| THERAPY COOL PATH CATHETER (P060019/S028) | Irvine Biomedical, Inc. | 2015-04-09 |
| COBAS AMPLICOR HCV TEST , VERSION 2.0 (P000012/S053) | Roche Molecular Systems, Inc. | 2015-04-09 |
| BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T (P000009/S061) | Biotronik, Inc. | 2015-04-09 |
| THERAPY COOL PATH DUO CATHETER (P110016/S012) | ABBOTT MEDICAL | 2015-04-09 |
| ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D (P950037/S148) | Biotronik, Inc. | 2015-04-09 |
| NEUROPACE RNS SYSTEM (P100026/S028) | NeuroPace, Inc. | 2015-04-08 |
| NEUROPACE RNS SYSTEM (P100026/S031) | NeuroPace, Inc. | 2015-04-08 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S025) | Infusyn Therapeutics, LLC | 2015-04-08 |
| ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S (P030035/S132) | ABBOTT MEDICAL | 2015-04-08 |
| PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S104) | Boston Scientific Corp | 2015-04-08 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S057) | Boston Scientific Corp | 2015-04-08 |
| RESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM (P110013/S049) | Medtronic Vascular | 2015-04-08 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S009) | Cochlear Americas | 2015-04-08 |
| RESTORE AND ITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S297) | Medtronic Neuromodulation | 2015-04-08 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S223) | Medtronic, Inc. | 2015-04-08 |
| AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS) (P010020/S030) | Boston Scientific Corp | 2015-04-08 |
| PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY (P030054/S283) | ABBOTT MEDICAL | 2015-04-08 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS (P910023/S354) | ABBOTT MEDICAL | 2015-04-08 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S254) | ABBOTT MEDICAL | 2015-04-08 |
| CARDIOMEMS HF SYSTEM (P100045/S004) | ABBOTT MEDICAL | 2015-04-08 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S103) | Boston Scientific Corp | 2015-04-07 |
| RADIESSE (P050037/S055) | Merz North America, Inc. | 2015-04-07 |
| RADIESSE, RADIESSE (+) (P050052/S061) | Merz North America, Inc. | 2015-04-07 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S054) | Boston Scientific Corp | 2015-04-07 |
| PRESTIGE (R) LP CERVICAL DISC (P090029/S001) | Medtronic Sofamor Danek USA, Inc. | 2015-04-06 |
| BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S067) | Boston Scientific | 2015-04-06 |
| BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S076) | Boston Scientific Corp | 2015-04-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER (P140010/S004) | Medtronic, Inc. | 2015-04-06 |
| GASTRIC EMPTYING BREATH TEST (GEBT) (P110015) | Advanced Breath Diagnostics | 2015-04-06 |
| CHILLI II COOLED ABLATION CATHETERS (P980003/S056) | Boston Scientific Corp | 2015-04-06 |
| CRYOCONSOLE (P100010/S048) | Medtronic Cryocath, LP | 2015-04-03 |
| RADIESSE DERMAL FILLER (P050052/S060) | Merz North America, Inc. | 2015-04-03 |
| CRYOCONSOLE (P020045/S066) | Medtronic Cryocath, LP | 2015-04-03 |
| INTERSTIM THERAPY SYSTEM (P970004/S194) | Medtronic Neuromodulation | 2015-04-03 |
| INTERSTIM THERAPY SYSTEM (P080025/S089) | Medtronic Neuromodulation | 2015-04-03 |
| PEARL 8.0 HANDPIECE (P970029/S027) | Cryolife, Inc. | 2015-04-03 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S075) | W. L. Gore & Associates, Inc. | 2015-04-03 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S041) | W. L. Gore & Associates, Inc. | 2015-04-03 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S123) | Cochlear Americas | 2015-04-02 |
| INTERSTIM THERAPY SYSTEM (P970004/S195) | Medtronic Neuromodulation | 2015-04-02 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S296) | Medtronic Neuromodulation | 2015-04-02 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S055) | Abbott Vascular | 2015-04-02 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S053) | St Jude Medical | 2015-04-02 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S014) | Medtronic Vascular, Inc. | 2015-04-02 |