| SETROX S 45, SETROX S 53, SETROX S 60, DEXTRUS 4135, DEXTRUS 4136, DEXTRUS 4137, SAFIO S 53, SAFIO S 60, TILDA JT45, TIL (P950037/S158) | Biotronik, Inc. | 2015-08-31 |
| LIVEWIRE TC ABLATION CATHETER (P960016/S055) | St Jude Medical | 2015-08-31 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S054) | Corcym S.r.l. | 2015-08-31 |
| COROX OTW 75-BP, COROX OTW 85-BP, COROX OTW-S 75-BP, COROX OTW-S 85-BP, COROX OTW-L 85-BP, COROX OTW-L 75-BP, CELERITY 2 (P070008/S068) | Biotronik, Inc. | 2015-08-31 |
| RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK (P040024/S081) | Q-Med AB | 2015-08-31 |
| EXABLATE (P040003/S015) | Insightec, Ltd. | 2015-08-31 |
| ZILVER VASCULAR STENT (P050017/S012) | Cook Ireland, Ltd. | 2015-08-31 |
| LINOX SMART SD 60/16, LINOX SMART SD 65/16, LINOX SMART SD 65/18, LINOX SMART SD 75/18, LINOX SMART TD 65/16, LINOX SMAR (P980023/S073) | Biotronik, Inc. | 2015-08-31 |
| GEL-ONE (P080020/S017) | Seikagaku Corp. | 2015-08-28 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S064) | Urologix, LLC | 2015-08-28 |
| GEL-ONE (P080020/S016) | Seikagaku Corp. | 2015-08-28 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S015) | Bausch & Lomb | 2015-08-28 |
| HYMOVIS (P150010) | Fidia Farmaceutici | 2015-08-28 |
| LOTRAFILCON B SOFT (HYDROPHILIC) CONTACT LENSE (P010019/S040) | Alcon Laboratories, Inc. | 2015-08-28 |
| VNS THERAPY MODEL 302 LEAD (P970003/S184) | LivaNova USA, Inc. | 2015-08-28 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S064) | ABBOTT MEDICAL | 2015-08-27 |
| EN VEO R DELIVERY SYSTEM (DCS)COMPONENT OF CORE VALUE EVOLUT R SYSTEM (P130021/S017) | Medtronic, Inc. | 2015-08-27 |
| IDEAL IMPLANT SALINE FILLED BREAST IMPLANT (P120011/S001) | Bimini Health Tech | 2015-08-27 |
| AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY OF PACEMAKERS (P880086/S255) | ABBOTT MEDICAL | 2015-08-27 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S355) | ABBOTT MEDICAL | 2015-08-27 |
| FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S133) | ABBOTT MEDICAL | 2015-08-27 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S065) | Medtronic | 2015-08-27 |
| SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S093) | St. Jude Medical, Inc. | 2015-08-27 |
| QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S284) | ABBOTT MEDICAL | 2015-08-27 |
| PHYSIO-STIM AND SPINAL-STIM (P850007/S034) | Orthofix, Inc. | 2015-08-26 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S003) | AtriCure, Inc. | 2015-08-26 |
| STRAUMANN EMDOGAIN (P930021/S014) | The Straumann Company | 2015-08-26 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S083) | Alcon Laboratories, Inc. | 2015-08-26 |
| CERVICAL-STIM (P030034/S008) | Orthofix, Inc. | 2015-08-26 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5 (P810031/S054) | Johnson & Johnson Surgical Vision, Inc. | 2015-08-25 |
| TECNIS TORIC 1-PIECE INTRAOCULAR LENS (P980040/S062) | Johnson & Johnson Surgical Vision, Inc. | 2015-08-25 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S231) | Boston Scientific Corp | 2015-08-25 |
| MINIMED 530G INSULIN PUMP (P120010/S052) | Medtronic, Inc. | 2015-08-25 |
| PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S176) | Medtronic Minimed | 2015-08-25 |
| INSPIRE UPPER AIRWAY STIMULATION THERAPY (P130008/S008) | Inspire Medical Systems | 2015-08-24 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S065) | Zoll Manufacturing Corporation | 2015-08-22 |
| DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, ORIGEN CRT-D, X4 CRT-D, INCEPTA TM ICD, ENERGEN TM ICD & PUNCTUA TM ICD (P010012/S397) | Boston Scientific Corp | 2015-08-21 |
| GENE2.0 S-ICD: A209 (P110042/S049) | Boston Scientific Corporation | 2015-08-21 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S040) | Baxter Healthcare Corp | 2015-08-21 |
| GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S021) | Lynch Biologics, LLC | 2015-08-21 |
| LCS TOTAL KNEE SYSTEM (P830055/S160) | Depuy, Inc. | 2015-08-21 |
| ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD (P960040/S353) | Boston Scientific | 2015-08-21 |
| PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R (P970003/S179) | LivaNova USA, Inc. | 2015-08-21 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S030) | DePuy Orthopaedics, Inc. | 2015-08-21 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S043) | ABBOTT MEDICAL | 2015-08-20 |
| EVERA S DR,SVR, XT DR.XT VR ICD'S; MAXIMO II ICD, PROTECTA ICD & XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S543) | Medtronic Cardiac Rhythm Disease Management | 2015-08-20 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S150) | Boston Scientific Corp | 2015-08-20 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S043) | Medtronic Vascular | 2015-08-20 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT (P840001/S309) | Medtronic Neuromodulation | 2015-08-20 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S236) | Medtronic, Inc. | 2015-08-20 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S012) | Cordis US Corporation | 2015-08-20 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S023) | Medtronic Vascular | 2015-08-20 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA CRT-D, VIVA (P010031/S507) | Medtronic Cardiac Rhythm Disease Management | 2015-08-20 |
| TACTICATH QUARTZ SET (P130026/S006) | St Jude Medical | 2015-08-20 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S033) | Dexcom, Inc. | 2015-08-19 |
| COLOGUARD (P130017/S003) | Exact Sciences Corporation | 2015-08-19 |
| SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS (N16895/S097) | Bausch & Lomb, Inc. | 2015-08-19 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S075) | Boston Scientific | 2015-08-19 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S062) | Boston Scientific Corp | 2015-08-19 |
| EVERA S DR ICD, S VR ICD; EVERA XT DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PRO (P980016/S542) | Medtronic Cardiac Rhythm Disease Management | 2015-08-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D,PROTECTA XT CRT-D, VIV (P010031/S506) | Medtronic Cardiac Rhythm Disease Management | 2015-08-19 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S054) | Medtronic Vascular | 2015-08-19 |
| SYNCHROMED INFUSION SYSTEM (P860004/S234) | Medtronic, Inc. | 2015-08-18 |
| REVO MRI SURESCAN IPG (P090013/S195) | Medtronic, Inc. | 2015-08-18 |
| FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS (P960004/S072) | Boston Scientific | 2015-08-18 |
| COLOGUARD (P130017/S002) | Exact Sciences Corporation | 2015-08-18 |
| ANIMAS VIBE SYSTEM (P130007/S007) | Animas Corp. | 2015-08-18 |
| THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S070) | Biosense Webster, Inc. | 2015-08-18 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S052) | Biosense Webster, Inc. | 2015-08-18 |
| SELECTSECURE LEAD (P030036/S079) | Medtronic Cardiac Rhythm Disease Management | 2015-08-18 |
| CONSULTA CRT-P,SYNCRA CRT-P,VIVA CRT-P (P010015/S276) | Medtronic, Inc. | 2015-08-18 |
| CAPSUREFIX LEAD (P930039/S136) | Medtronic, Inc. | 2015-08-18 |
| ADVISA DR IPG, ADVISA DR MRI IPG,ADVISA SR MRI IPG (P980035/S433) | Medtronic, Inc. | 2015-08-18 |
| CELSIUS FLTR BI-DIRECTIONAL CATHETER (P010068/S048) | Biosense Webster, Inc. | 2015-08-18 |
| CELSIUS FLTR UNI -DIRECTIONAL CATHETER (P950005/S058) | Biosense Webster, Inc. | 2015-08-18 |
| ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR (P850051/S084) | Medtronic, Inc. | 2015-08-17 |
| ENTRUST, GEMFAMILY, INTRINSCI, MARGUIS, MAXIMO FAMILY, ONYX, PROTECTA FAMILY,SECURA FAMILY,VITITUSO, EVERA FAMILY (P980016/S541) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| REVO MRI, ENRHYTHM MRI (P090013/S193) | Medtronic, Inc. | 2015-08-17 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600,KAPPA 650,KAPPA 700,KAPPA 800,KAPPA 900, RELIA,SENSIA,SIGMA, VERSA (P980035/S431) | Medtronic, Inc. | 2015-08-17 |
| KAPPA 400 (P970012/S098) | Medtronic, Inc. | 2015-08-17 |
| GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD (P900061/S136) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| ELITE &II, MINUET,PREVA PREVA D PRODIGY SYNERGYST II,THERA &I, , VITATRON LEGACY, VITATRON LEGAACY,REVEAL (P890003/S333) | Medtronic, Inc. | 2015-08-17 |
| DIVA AND DEMA FAMILIES PULSE GNERATORS (P990001/S121) | Medtronic, Inc. | 2015-08-17 |
| LEGEND PLUS (P930022/S019) | Medtronic, Inc. | 2015-08-17 |
| CONCERTO, INSYNC, MACIMO, PROTECTA AND VIVA FAMILIES AND BRAVA CRTS-D'S (P010031/S505) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| JEWEL AF, GEM III AT (P980050/S101) | Medtronic, Inc. | 2015-08-17 |
| CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P, VIVA CRT-P (P010015/S275) | Medtronic, Inc. | 2015-08-17 |
| PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST (P820003/S135) | Medtronic Cardiac Rhythm Disease Management | 2015-08-17 |
| PCD (P920015/S159) | Medtronic, Inc. | 2015-08-17 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S075) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S045) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S024) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S120) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S114) | Advanced Bionics | 2015-08-14 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S085) | W. L. Gore & Associates, Inc. | 2015-08-14 |
| AMPLATZER SEPTAL DEFECT OCCLUDER (P000039/S050) | ABBOTT MEDICAL | 2015-08-14 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S030) | Abbott Laboratories, Inc. | 2015-08-13 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S040) | Abbott Laboratories | 2015-08-13 |
| ARCHITECT TOTAL PSA (LN 6C06) (P910007/S049) | Abbott Laboratories | 2015-08-13 |
| QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS (P030054/S150) | ABBOTT MEDICAL | 2015-08-13 |