| Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemakers (P950029/S111) | MicroPort CRM USA, Inc. | 2016-09-27 |
| WOLVERINE CORONARY CUTTING BALLOON MONORAIL, OVER-THE WIRE. (P950020/S075) | Boston Scientific Corp | 2016-09-27 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S023) | Boston Scientific Corp | 2016-09-27 |
| MYOPORE SUTURELESS MYOCARDIAL PACING LEAD (P130012/S002) | Great Batch Medical | 2016-09-27 |
| Assurity, Assurity+, Endurity, Endurity Core (P880086/S275) | ABBOTT MEDICAL | 2016-09-27 |
| XIENCE XPEDITION & ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S086) | Abbott Vascular | 2016-09-27 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S030) | Boston Scientific Corp | 2016-09-27 |
| CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP (P890055/S065) | Intera Oncology | 2016-09-26 |
| TENDRIL ST, STS AND OPTISENSE LV LEADS (P960013/S083) | ABBOTT MEDICAL | 2016-09-26 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S023) | Edwards Lifesciences, LLC | 2016-09-25 |
| COBAS KRAS MUTATION TEST (P140023/S004) | Roche Molecular Systems, Inc. | 2016-09-24 |
| FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021) | Abbott Diabetes Care, Inc. | 2016-09-23 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S005) | Corcym S.r.l. | 2016-09-23 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S015) | Tandem Diabetes Care, Inc. | 2016-09-23 |
| LIPOSORBER® LA-15 SYSTEM (P910018/S020) | Kaneka Pharma America Corp. | 2016-09-23 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S029) | Corcym Canada Corp | 2016-09-23 |
| MYNXGRIP AND MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S074) | Cordis US Corporation | 2016-09-23 |
| Falope-Ring Band Contraceptive Tubal Occlusion System (P870076/S023) | Gyrus Acmi, Inc. | 2016-09-23 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S002) | Agilent Technologies, Inc. | 2016-09-23 |
| SOLO SMART STENTLESS HEART VALVE (P130011/S005) | Corcym Canada Corp | 2016-09-23 |
| LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S028) | Lenstec, Inc. | 2016-09-22 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S034) | Allergan | 2016-09-22 |
| Adapta, Versa, Sensia IPG AND Relia IPG (P980035/S470) | Medtronic, Inc. | 2016-09-22 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S030) | W. L. Gore & Associates, Inc. | 2016-09-22 |
| Sofmed Toric Weeklies (P890023/S025) | The Cooper Companies | 2016-09-22 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S172) | Depuy, Inc. | 2016-09-22 |
| INTEGRA Artificial Skin Dermal Regeneration Template (P900033/S057) | Integra Lifesciences Corp. | 2016-09-22 |
| Gore VIABAHN ENDOPROSTHESIS (P040037/S091) | W. L. Gore & Associates, Inc. | 2016-09-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S136) | W. L. Gore & Associates, Inc. | 2016-09-22 |
| THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROPHYSIOLOGY (P040036/S057) | Biosense Webster, Inc. | 2016-09-21 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S032) | W. L. Gore & Associates, Inc. | 2016-09-21 |
| CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER (P950005/S062) | Biosense Webster, Inc. | 2016-09-21 |
| ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540. (P980049/S122) | MicroPort CRM USA, Inc. | 2016-09-21 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S045) | Syncardia Systems, LLC | 2016-09-21 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S093) | W. L. Gore & Associates, Inc. | 2016-09-21 |
| NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S052) | Biosense Webster, Inc. | 2016-09-21 |
| CapSureFix Novus Lead Model 4076 (P930039/S157) | Medtronic, Inc. | 2016-09-21 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S039) | DePuy Orthopaedics, Inc. | 2016-09-21 |
| NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S050) | Biosense Webster, Inc. | 2016-09-21 |
| MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S003) | Axora Medical, Inc. | 2016-09-21 |
| CapSure Sense Lead Models 4074, 4574 (P830061/S133) | Medtronic Cardiac Rhythm Disease Management | 2016-09-21 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S038) | DePuy Orthopaedics, Inc. | 2016-09-21 |
| CRT-Ds (Cardiac Resynchronization Therapy Defibrillator),Platinium CRT-D 1711, 01741 (P060027/S087) | MicroPort CRM USA, Inc. | 2016-09-21 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S049) | W. L. Gore & Associates, Inc. | 2016-09-21 |
| EZ STEER THERMOCOOL NAVIGATION AND THERMOCOOL BI-DIRECTIONAL CATHETER;THERMOCOOL SF/SF NAV BI-DIRECTIONAL AND SF/SF NAV (P030031/S077) | Biosense Webster, Inc. | 2016-09-21 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S023) | ETHICON, Inc. | 2016-09-20 |
| THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S076) | Biosense Webster, Inc. | 2016-09-20 |
| Sprint Quattro Lead; Subcutaneous Lead (P920015/S182) | Medtronic, Inc. | 2016-09-20 |
| COBAS KRAS MUTATION TEST (P140023/S007) | Roche Molecular Systems, Inc. | 2016-09-20 |
| COBAS EGFR MUTATION TEST (P150047/S001) | Roche Molecular Systems, Inc. | 2016-09-20 |
| SURGICEL ABSORBABLE HEMOSTAT (N12159/S039) | ETHICON, Inc. | 2016-09-20 |
| Attain Ability Lead, Attain Performa Lead (P080006/S097) | Medtronic, Inc. | 2016-09-20 |
| COBAS EGFR MUTATION TEST (P120019/S011) | Roche | 2016-09-20 |
| CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B (P930039/S156) | Medtronic, Inc. | 2016-09-20 |
| Paradym VR, DR,Paradym RF VR, Paradym RF DR (ZL101),(ZL102),Intensia VR, Intensia DR,Platinium VR 1210, Platinium VR 124 (P980049/S120) | MicroPort CRM USA, Inc. | 2016-09-20 |
| Myocardial Pacing Lead (P120017/S005) | Medtronic, Inc. | 2016-09-20 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S018) | Roche Molecular Systems, Inc. | 2016-09-20 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S010) | Reshape Lifesciences, Inc. | 2016-09-20 |
| LCS KNEE SYSTEM (P830055/S175) | Depuy, Inc. | 2016-09-20 |
| CapSure Sense Lead; Vitatron Crystalline Lead, ICM09 (P830061/S132) | Medtronic Cardiac Rhythm Disease Management | 2016-09-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S053) | Edwards Lifesciences, LLC | 2016-09-20 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S083) | Medtronic | 2016-09-20 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004/S011) | Ev3 Neurovascular | 2016-09-20 |
| Paradym CRT-D; Paradym RF CRT-D (ZL101),(ZL102); Intensia CRT-D; Platinium CRT-D 1711,1741. (P060027/S085) | MicroPort CRM USA, Inc. | 2016-09-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S064) | Edwards Lifesciences, LLC | 2016-09-19 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S153) | Edwards Lifesciences, LLC | 2016-09-19 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S006) | Gen-Probe Incorporated | 2016-09-19 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S012) | Bolton Medical, Inc. | 2016-09-19 |
| INFINITY NEUROSTIMULATION SYSTEM (P010032/S097) | ABBOTT MEDICAL | 2016-09-19 |
| MYOPORE SUTURELESS MYOCARDIAL PACING LEAD (P130012/S001) | Great Batch Medical | 2016-09-19 |
| APTIMA HPV ASSAY (P100042/S008) | Gen-Probe Incorporated | 2016-09-19 |
| APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S009) | Gen-Probe | 2016-09-19 |
| INFINITY NEUROSTIMULATION SYSTEM (P140009/S001) | ABBOTT MEDICAL | 2016-09-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S022) | Edwards Lifesciences, LLC | 2016-09-19 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S018) | Boston Scientific Corporation | 2016-09-16 |
| DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S049) | Dexcom, Inc. | 2016-09-16 |
| INFUSE BONE GRAFT (P050053/S035) | Medtronic, Inc. | 2016-09-16 |
| INFUSE BONE GRAFT (P000054/S044) | Medtronic Sofamor Danek USA, Inc. | 2016-09-16 |
| INFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE (P000058/S060) | Medtronic Sofamor Danek USA, Inc. | 2016-09-16 |
| TECNIS 1-Piece IOL; OptiBlue; Multifocal; Toric 1-Piece IOLs; TECNIS i Tee Preloaded Delivery System; Symfont Extended R (P980040/S073) | Johnson & Johnson Surgical Vision, Inc. | 2016-09-16 |
| PRECISION, PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S256) | Boston Scientific Corp | 2016-09-16 |
| Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AM MRI VR ICD and Visia AF VR ICD (P980016/S598) | Medtronic Cardiac Rhythm Disease Management | 2016-09-15 |
| MED-EL COCHLEAR IMPLANT SYSTEM (P000025/S084) | Med-El Corp. | 2016-09-15 |
| HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S072) | Integra LifeSciences Corporation | 2016-09-15 |
| COLLACOTE(TM) COLLATAPE(R) ABSORBABLE COLLEGAGEN WOUND DRESSINGS (P840062/S057) | Integra Lifesciences Corp. | 2016-09-15 |
| Amplia MRI & Quad CRT-D's; Brava CRT-D & Quad CRT-D's; Compia MRI CRT-D & Quad CRT-D; Viva Quad S & XT CRT-D; Viva S CR (P010031/S559) | Medtronic Cardiac Rhythm Disease Management | 2016-09-15 |
| COLLASTAT / INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S073) | Integra LifeSciences Corporation | 2016-09-15 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S120) | ABBOTT MEDICAL | 2016-09-15 |
| ANIMAS VIBE SYSTEM (P130007/S020) | Animas Corp. | 2016-09-15 |
| INTEGRA ARTIFICAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S056) | Integra Lifesciences Corp. | 2016-09-15 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S017) | ABBOTT MEDICAL | 2016-09-15 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S011) | Abbott Vascular-Cardiac Therapies | 2016-09-14 |
| INTERSTIM THERAPY SYSTEM (P080025/S122) | Medtronic Neuromodulation | 2016-09-14 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S342) | Medtronic Neuromodulation | 2016-09-14 |
| SUPARTZ FX VISCO-3 (P980044/S035) | Seikagaku Corp. | 2016-09-14 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S030) | Corcym Canada Corp | 2016-09-14 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S043) | Baxter Healthcare Corp | 2016-09-14 |
| Activa Deep Brain Stimulation Therapy System (P960009/S263) | Medtronic, Inc. | 2016-09-14 |
| INTERSTIM THERAPY SYSTEM (P970004/S227) | Medtronic Neuromodulation | 2016-09-14 |
| Ingenio 2 Pacemakers, ALTURA 2, ESSENTIO, PROPONENT, ACCOLADE MODEL'S (N970003/S193) | Boston Scientific Corp | 2016-09-13 |