| BELOTERO BALANCE (P090016/S018) | Merz North America, Inc. | 2015-12-11 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S040) | Neomend, Inc. | 2015-12-11 |
| ANGIOJET XMI THROMBECTOMY SET, ANGIOJET SPIROFLEX THROMBECTOMY SET, ANGIOJEET SPIROFLEX VG THROMBECTOMY SET, ANGIOJET DI (P980037/S053) | Boston Scientific Corp | 2015-12-11 |
| ASCENDRA+ DELIVERY SYSTEM, NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET CRIMPER, QUALCRIMP CRIMPI (P130009/S042) | Edwards Lifesciences, LLC | 2015-12-11 |
| RADIESSE (P050037/S063) | Merz North America, Inc. | 2015-12-11 |
| SUPERION INTERSPINOUS SPACER SYSTEM (P140004/S003) | Boston Scientific Neuromodulation | 2015-12-11 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL) (P110016/S026) | ABBOTT MEDICAL | 2015-12-11 |
| RADIESSE, RADIESSE (+) [RADIESSE WITH LIDOCAINE] (P050052/S074) | Merz North America, Inc. | 2015-12-11 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S024) | Smith & Nephew, Inc. | 2015-12-11 |
| SUPARTZ FX (P980044/S029) | Seikagaku Corp. | 2015-12-10 |
| LOGICON CARIES DETECTOR (P980025/S003) | Carestream Dental, LLC | 2015-12-10 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S032) | DePuy Orthopaedics, Inc. | 2015-12-10 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S066) | Medtronic | 2015-12-10 |
| VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) (P030016/S029) | STAAR Surgical Company | 2015-12-10 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S053) | Vistakon, Division of Johnson & Johnson Vision Car | 2015-12-10 |
| PARADIGM REAL-TIME SYSTEM,PARADIGM REAL-TIME REVEL SYSTEM (P980022/S186) | Medtronic Minimed | 2015-12-09 |
| BRIO IPG (P140009/S009) | ABBOTT MEDICAL | 2015-12-09 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S052) | Boston Scientific Corp | 2015-12-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S071) | Zoll Manufacturing Corporation | 2015-12-09 |
| NEUROPACE RNS SYSTEM (P100026/S039) | NeuroPace, Inc. | 2015-12-09 |
| PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S188) | Medtronic Minimed | 2015-12-09 |
| SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) (P110042/S056) | Boston Scientific Corporation | 2015-12-09 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S049) | Bard Peripheral Vascular, Inc. | 2015-12-09 |
| EON MINI (IMPLANTABLE PULSE GENERATOR) IPG, PROTEGE IPG, PROTEGE IPG MRI (P010032/S107) | ABBOTT MEDICAL | 2015-12-09 |
| MINIMED 530G SYSTEM (P120010/S077) | Medtronic, Inc. | 2015-12-09 |
| HOME ACCESS HEPATITIS C CHECK (P980046/S009) | Pwn Health Chicago, LLC | 2015-12-09 |
| MINIMED 530G (P120010/S079) | Medtronic, Inc. | 2015-12-09 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S036) | Syncardia Systems, LLC | 2015-12-09 |
| VIVA, BRAVA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT (P010031/S520) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI, ENPULSE, KAPPA IPGS (P980035/S446) | Medtronic, Inc. | 2015-12-08 |
| MY CARELINK PATIENT MONITOR MODEL 24950 (P890003/S341) | Medtronic, Inc. | 2015-12-08 |
| CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD (P830061/S123) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| REVO MRI, SURESCAN IPG (P090013/S207) | Medtronic, Inc. | 2015-12-08 |
| EVERA MRI ICD, MARQUIS, SECURA, MAXIMO II, INTRINSIC,PROTECTA, PROTECTA XT, VIRTUOSO II (P980016/S558) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| REVO MRI, SURESCAN IPG (P090013/S206) | Medtronic, Inc. | 2015-12-08 |
| PARADIGM REAL-TIME INSULIN PUMP;PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S187) | Medtronic Minimed | 2015-12-08 |
| MEDTRONIC MYCARELINK PATIENT MONITOR MODEL 24950 (P890003/S342) | Medtronic, Inc. | 2015-12-08 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S443) | Medtronic, Inc. | 2015-12-08 |
| EVERA MRI ICD, S DR, XT DR ICD, XT VR ICD, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT IC (P980016/S556) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S285) | Medtronic, Inc. | 2015-12-08 |
| MINIMED 530G INSULIN PUMP (P120010/S078) | Medtronic, Inc. | 2015-12-08 |
| BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT (P010031/S517) | Medtronic Cardiac Rhythm Disease Management | 2015-12-08 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S283) | Medtronic, Inc. | 2015-12-08 |
| DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D (P010012/S404) | Boston Scientific Corp | 2015-12-07 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S028) | Edwards Lifesciences, LLC | 2015-12-07 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES (P880086/S264) | ABBOTT MEDICAL | 2015-12-07 |
| ANTHEM,ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S142) | ABBOTT MEDICAL | 2015-12-07 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019) | Medtronic Minimed | 2015-12-07 |
| DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S359) | Boston Scientific | 2015-12-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S065) | Edwards Lifesciences, LLC | 2015-12-07 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S052) | Edwards Lifesciences, LLC | 2015-12-07 |
| ANTHEM, ALLURE/RF, ALLURA QUADRA/RF FAMILY OF CRT-P'S (P030035/S140) | ABBOTT MEDICAL | 2015-12-06 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S262) | ABBOTT MEDICAL | 2015-12-06 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+FAMILY OF ICDS (P910023/S364) | ABBOTT MEDICAL | 2015-12-06 |
| PROMOTE/+RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+HF, (P030054/S294) | ABBOTT MEDICAL | 2015-12-06 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER (P140010/S009) | Medtronic, Inc. | 2015-12-04 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S130) | Cochlear Americas | 2015-12-04 |
| ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL (P930014/S085) | Alcon Laboratories, Inc. | 2015-12-04 |
| EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL) (P910056/S021) | Bausch & Lomb, Inc. | 2015-12-04 |
| INFUSE(R) BONE GRAFT (P000058/S059) | Medtronic Sofamor Danek USA, Inc. | 2015-12-04 |
| EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS) (P010032/S106) | ABBOTT MEDICAL | 2015-12-04 |
| TRANSCEND HIP ARTICULATION SYSTEM (P010001/S014) | Ceramtec GmbH | 2015-12-04 |
| PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S184) | Medtronic Minimed | 2015-12-04 |
| BRIO IMPLANTABLE PULSE GENERATORS (IPGS) (P140009/S008) | ABBOTT MEDICAL | 2015-12-04 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION NOVI SPI (P030017/S242) | Boston Scientific Corp | 2015-12-04 |
| SEPRAFILM ADHESION BARRIER (P950034/S043) | Baxter Healthcare Corporation | 2015-12-03 |
| MINIMED 530G INSULIN PUMP (P120010/S075) | Medtronic, Inc. | 2015-12-03 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S117) | Boston Scientific Corp | 2015-12-03 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP) (P040044/S066) | Cordis US Corporation | 2015-12-03 |
| SLS II AND GLIDELIGHT LASER SHEATH KITS (P960042/S052) | Spectranetics (Philips) | 2015-12-03 |
| PLASMAFLO (P820033/S009) | Asahi Kasei Medical Co., Ltd. | 2015-12-03 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S001) | Boston Scientific Corporation | 2015-12-03 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S182) | Medtronic Minimed | 2015-12-03 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S068) | Medtronic | 2015-12-03 |
| RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S317) | Medtronic Neuromodulation | 2015-12-03 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S069) | Zoll Manufacturing Corporation | 2015-12-03 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S082) | Med-El Corp. | 2015-12-03 |
| LOTRAFILCON B SOFT CONTACT LENSES O2OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL. (P010019/S042) | Alcon Laboratories, Inc. | 2015-12-03 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S081) | Spectranetics Corp. | 2015-12-03 |
| GORE VIABAHN ENDOPROSTHESIS; GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S087) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S057) | Endologix, LLC | 2015-12-02 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S002) | Nevro Corporation | 2015-12-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOAVTIVE SURFACE (P130006/S026) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| TACTICATH QUARTZ SET (P130026/S005) | St Jude Medical | 2015-12-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S086) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S025) | W. L. Gore & Associates, Inc. | 2015-12-02 |
| ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R (P050038/S027) | Davol, Inc. | 2015-12-02 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET (P980037/S051) | Boston Scientific Corp | 2015-12-02 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S032) | Boston Scientific Corp | 2015-11-30 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S007) | Cardiovascular Systems, Inc. | 2015-11-30 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S006) | Boston Scientific Corporation | 2015-11-30 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S032) | Syncardia Systems, LLC | 2015-11-27 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S035) | ETHICON, Inc. | 2015-11-27 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S033) | Cordis US Corporation | 2015-11-25 |
| GEL-ONE (P080020/S018) | Seikagaku Corp. | 2015-11-25 |
| VNS THERAPY MODEL 303 LEAD (P970003/S187) | LivaNova USA, Inc. | 2015-11-25 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S286) | Medtronic, Inc. | 2015-11-25 |
| PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S029) | Cordis US Corporation | 2015-11-25 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUISI II DR/VR ICD (P980016/S559) | Medtronic Cardiac Rhythm Disease Management | 2015-11-25 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S040) | Dexcom, Inc. | 2015-11-25 |