| ARCHITECT AFP ASSAY (LN 3P36) (P120008/S008) | Abbott Laboratories | 2015-07-13 |
| ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS (P110029/S021) | Abbott Laboratories | 2015-07-13 |
| TUNNELING TOOL (P920015/S158) | Medtronic, Inc. | 2015-07-13 |
| ACRYSOF INTRAOCULAR LENSES, ACRYSOF RESTOR INTRAOCULAR LENSES (P930014/S081) | Alcon Laboratories, Inc. | 2015-07-13 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S257) | ABBOTT MEDICAL | 2015-07-13 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S135) | ABBOTT MEDICAL | 2015-07-13 |
| ADAPTA, VERSA, SENSIA, RELIA, IPG (P980035/S428) | Medtronic, Inc. | 2015-07-11 |
| ADVIA CENTAUR HCV ASSAY (P030056/S010) | Siemens Healthcare Diagnostics | 2015-07-10 |
| INTERSTIM THERAPY SYSTEM (P970004/S200) | Medtronic Neuromodulation | 2015-07-10 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S002) | ABBOTT MEDICAL | 2015-07-10 |
| ADVIA CENTAUR HBC IGM ASSAY (P030040/S010) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY (P100039/S003) | Siemens Healthcare Diagnostics, Inc. | 2015-07-10 |
| ADVIA CENTAUR HBSAGII ASSAY (P110041/S002) | Siemens Corp. | 2015-07-10 |
| INTERSTIM THERAPY SYSTEM (P080025/S095) | Medtronic Neuromodulation | 2015-07-10 |
| ADVIA CENTAUR HBEAG ASSAY (P090024/S002) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR HBSAG ASSAY (P030049/S012) | Siemens Healthcare Diagnostics | 2015-07-10 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S011) | Siemens Healthcare Diagnostics | 2015-07-10 |
| THERASCEEN EGFR RGQ PCR KIT (P120022/S001) | QIAGEN GmbH | 2015-07-10 |
| SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS (P110016/S014) | ABBOTT MEDICAL | 2015-07-09 |
| THERAPY DUAL ABLATION CATHETER, SAFIRE TX ABLATION CATHETER (P040042/S029) | Irvine Biomedical,Inc.(Ibi) | 2015-07-09 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S030) | Irvine Biomedical, Inc. | 2015-07-09 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S041) | Medtronic Vascular | 2015-07-09 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S006) | Medtronic Vascular | 2015-07-09 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S080) | Medtronic, Ireland | 2015-07-09 |
| FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL) (P110016/S018) | ABBOTT MEDICAL | 2015-07-09 |
| COREVALVE SYSTEM (P130021/S012) | Medtronic, Inc. | 2015-07-09 |
| ARTUS CMV RGQ MDX KIT (P130027/S001) | Qiagen, Inc. | 2015-07-09 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S050) | Medtronic Vascular | 2015-07-09 |
| THERAPY ABLATION CATHETER (P040014/S024) | Irvine Biomedical, Inc. | 2015-07-09 |
| IN.PACT ADMIRAL DCB (P140010/S005) | Medtronic, Inc. | 2015-07-09 |
| PROGENSA PCA3 ASSAY (P100033/S005) | Gen-Probe Incorporated | 2015-07-09 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S118) | W. L. Gore & Associates, Inc. | 2015-07-09 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S061) | Medtronic | 2015-07-09 |
| VALIANT THORACIC STENTGRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S020) | Medtronic Vascular | 2015-07-09 |
| LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER (P960016/S050) | St Jude Medical | 2015-07-09 |
| ENDURANT AND ENDURANT II STENT SYSTEM (P100021/S046) | Medtronic Vascular | 2015-07-09 |
| GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S092) | ABBOTT MEDICAL | 2015-07-09 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CORONARY STENT SYSTEM (P110010/S113) | Boston Scientific Corp | 2015-07-09 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S015) | Medtronic Vascular | 2015-07-09 |
| ASSURANT COLBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM (P110011/S010) | Medtronic, Ireland | 2015-07-09 |
| ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S149) | Boston Scientific Corp | 2015-07-09 |
| IMPELLA 2.5 SYSTEM (P140003/S003) | Abiomed, Inc. | 2015-07-08 |
| VASCADE VASCULAR CLOSURE SYSTEM (VCS) (P120016/S015) | Cardiva Medical, Inc. | 2015-07-08 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S063) | Medtronic | 2015-07-08 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S033) | Beckman Coulter, Inc. | 2015-07-08 |
| DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR (P970003/S180) | LivaNova USA, Inc. | 2015-07-08 |
| ACTIVA PC NEUROSTIMULATOR (P960009/S232) | Medtronic, Inc. | 2015-07-08 |
| RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, RESTOREADVANCED NEUROSTIMULATOR, PRIMEADVANCED SURESCAN MRI (P840001/S305) | Medtronic Neuromodulation | 2015-07-08 |
| SPRINT QUATTRO LEAD (P920015/S156) | Medtronic, Inc. | 2015-07-07 |
| PROTEGO SD 60/16, PROTEGO SD 65/16, PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGO TD 65/16, PROTEGO TD 65/18, PROTEGO TD (P980023/S069) | Biotronik, Inc. | 2015-07-07 |
| PROMUS ELEMENT PLUS EVEROLIMUS - ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S099) | Boston Scientific Corp | 2015-07-07 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S005) | Cardiovascular Systems, Inc. | 2015-07-07 |
| EVIA HF,EVIA HF-T, ENTOVIS HF,ENTOVIS HF-T (P070008/S067) | Biotronik, Inc. | 2015-07-07 |
| EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES (P950037/S157) | Biotronik, Inc. | 2015-07-07 |
| RADIESSE (+) 1.5CC, RADIESSE (+) 0.8CC (P050052/S067) | Merz North America, Inc. | 2015-07-06 |
| GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S093) | ABBOTT MEDICAL | 2015-07-06 |
| FLEXABILITY ABLATION CATHETER (P110016/S016) | ABBOTT MEDICAL | 2015-07-02 |
| BELOTERO BALANCE (P090016/S017) | Merz North America, Inc. | 2015-07-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S060) | Medtronic | 2015-07-02 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S031) | Zimmer, Inc. | 2015-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S117) | W. L. Gore & Associates, Inc. | 2015-07-02 |
| VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT (P110012/S009) | Abbott Molecular, Inc. | 2015-07-02 |
| DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S036) | Dexcom, Inc. | 2015-07-02 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S062) | Medtronic | 2015-07-02 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S112) | Boston Scientific Corp | 2015-07-01 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S029) | Mentor Corp. | 2015-07-01 |
| INTERSTIM THERAPY SYSTEM (P970004/S199) | Medtronic Neuromodulation | 2015-07-01 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S121) | Boston Scientific Corp | 2015-07-01 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S012) | Mentor Worldwide, LLC | 2015-07-01 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATUION LEA (P840001/S304) | Medtronic Neuromodulation | 2015-07-01 |
| INTERSTIM THERAPY SYSTEM (P080025/S094) | Medtronic Neuromodulation | 2015-07-01 |
| SYNCHROMED DRUG INFUSION SYSTEM (P860004/S230) | Medtronic, Inc. | 2015-07-01 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S014) | Boston Scientific Corp | 2015-07-01 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S231) | Medtronic, Inc. | 2015-07-01 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S015) | Boston Scientific Corp | 2015-07-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS ELUTING STENT SYSTEM, PROMUS PREMIER EVEROLIMUS ELUTING STENT SYSTEM (P110010/S111) | Boston Scientific Corp | 2015-07-01 |
| RESTYLANE, RESTYLANE-L,PERLANE,PERLANE-L,RESTYLANE SILK (P040024/S073) | Q-Med AB | 2015-07-01 |
| MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT (P990075/S033) | Mentor Worldwide, LLC | 2015-07-01 |
| ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S120) | Boston Scientific Corp | 2015-07-01 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK (P810031/S053) | Johnson & Johnson Surgical Vision, Inc. | 2015-07-01 |
| NEUROPACE RNS SYSTEM (P100026/S033) | NeuroPace, Inc. | 2015-06-30 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S012) | Highridge Medical, LLC | 2015-06-30 |
| ACUITY STEERABLE LEAD (P050046/S025) | Guidant Corp. | 2015-06-30 |
| EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD (P010012/S390) | Boston Scientific Corp | 2015-06-30 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S012) | Highridge Medical, LLC | 2015-06-30 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S062) | Zoll Manufacturing Corporation | 2015-06-30 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S002) | Lutonix | 2015-06-30 |
| NEUROPACE RNS SYSTEM (P100026/S034) | NeuroPace, Inc. | 2015-06-30 |
| FINELINE II STEROX ENDOCARDIAL PACING LEAD (P960004/S069) | Boston Scientific | 2015-06-30 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S045) | Medtronic | 2015-06-29 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S274) | Medtronic, Inc. | 2015-06-29 |
| MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEAD (P080006/S081) | Medtronic, Inc. | 2015-06-29 |
| ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S041) | Bayer Pharma AG | 2015-06-29 |
| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S/XT CRT-D'S (P010031/S502) | Medtronic Cardiac Rhythm Disease Management | 2015-06-29 |
| ADVISA DR IPG, ADVISA DR MRI IPG AND ADVISA SR MRI IPG (P980035/S426) | Medtronic, Inc. | 2015-06-29 |
| EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICD'S (P980016/S539) | Medtronic Cardiac Rhythm Disease Management | 2015-06-29 |
| ADVISA SR MRI (P980035/S427) | Medtronic, Inc. | 2015-06-27 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL (P080025/S083) | Medtronic Neuromodulation | 2015-06-26 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S230) | Medtronic, Inc. | 2015-06-26 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S228) | Boston Scientific Corp | 2015-06-26 |