| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S036) | Medtronic | 2014-02-21 |
| MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS (P110002/S004) | Highridge Medical, LLC | 2014-02-21 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S087) | Medtronic, Inc. | 2014-02-21 |
| OPTISURE (P950022/S085) | ABBOTT MEDICAL | 2014-02-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S091) | W. L. Gore & Associates, Inc. | 2014-02-21 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S048) | Zoll Manufacturing Corporation | 2014-02-21 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S035) | Allergan | 2014-02-21 |
| JUVEDERM VOLUMA XC (P110033/S004) | Allergan | 2014-02-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S115) | Cochlear Americas | 2014-02-21 |
| NEUROPACE RNS SYSTEM (P100026/S009) | NeuroPace, Inc. | 2014-02-21 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S053) | Corcym S.r.l. | 2014-02-20 |
| MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS (P990075/S025) | Mentor Worldwide, LLC | 2014-02-20 |
| WAVELIGHT EX500 LASER SYSTEM (P020050/S016) | Alcon Laboratories, Inc. | 2014-02-20 |
| WAVELIGHT EX500 LASER SYSTEM (P030008/S014) | Alcon Laboratories, Inc. | 2014-02-20 |
| SCULPTRA & SCULPTRA AESTHETIC ( INJECTABLE POLY-L LACTIC ACID) (P030050/S020) | Q-Med AB | 2014-02-19 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S026) | Bunnell, Inc. | 2014-02-19 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) (P100025/S006) | Meridian Bioscience, Inc. | 2014-02-19 |
| CAPSURE SENSE LEAD (P830061/S086) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| ZIMMER NEXGEN LPS FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S024) | Zimmer, Inc. | 2014-02-18 |
| ATTAIN ABILITY LEAD (P080006/S066) | Medtronic, Inc. | 2014-02-18 |
| REVO MRI IPG (P090013/S128) | Medtronic, Inc. | 2014-02-18 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFYASSURA FAMILIES OF ICD DEVICES (P910023/S327) | ABBOTT MEDICAL | 2014-02-18 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S421) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| PROMOTE, QUADRA ASSURA, UNITY, UNITY ASSURA, UNIFY QUADRA FAMILIES CRT-D DEVICES (P030054/S258) | ABBOTT MEDICAL | 2014-02-18 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S364) | Medtronic, Inc. | 2014-02-18 |
| NEURO PACE RNS SYSTEM (P100026/S005) | NeuroPace, Inc. | 2014-02-18 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S459) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S232) | Medtronic, Inc. | 2014-02-18 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S457) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P010031/S419) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| PRECISION SPECTRA SYSTEM (P030017/S181) | Boston Scientific Corp | 2014-02-16 |
| NEUROPACE RNS SYSTEM (P100026/S006) | NeuroPace, Inc. | 2014-02-14 |
| REVO MRI IPG (P090013/S112) | Medtronic, Inc. | 2014-02-14 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, DR MRI IPG, ENPULSE EL IPG, E2 IPG, ENRHYTHM IPG, KAPPA D IPG (P980035/S343) | Medtronic, Inc. | 2014-02-14 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S215) | Medtronic, Inc. | 2014-02-14 |
| NEUROPACE RNS SYSTEM (P100026/S008) | NeuroPace, Inc. | 2014-02-14 |
| ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO (P980016/S436) | Medtronic Cardiac Rhythm Disease Management | 2014-02-14 |
| INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM (P010031/S397) | Medtronic Cardiac Rhythm Disease Management | 2014-02-14 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S024) | Allergan | 2014-02-14 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S006) | Allergan | 2014-02-14 |
| MYCARELINK PATIENT MONITOR, DEVICE DATA MANAGEMENT APPLICATION, APPLICATION SOFTWARE (P890003/S285) | Medtronic, Inc. | 2014-02-14 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S107) | Advanced Bionics | 2014-02-14 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S026) | Medtronic | 2014-02-14 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S101) | Boston Scientific Corp | 2014-02-13 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS- ELUTING STENT SYSTEM (P110010/S065) | Boston Scientific Corp | 2014-02-13 |
| BLAZER II XPCARDIAC ABLATION CATHETER AND CABLE (P020025/S053) | Boston Scientific | 2014-02-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S058) | Boston Scientific Corp | 2014-02-13 |
| EXPRESS 2 MONORAIL AND OVER THE WIRE (P020009/S115) | Boston Scientific Scimed, Inc. | 2014-02-13 |
| ROTABLATOR ROTATIONAL ANGIOPASTY SYSTEM GUIDEWIRE (P900056/S131) | Boston Scientific Corp | 2014-02-13 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S065) | Boston Scientific Corp | 2014-02-13 |
| HEART WARE VENTRICULAR ASSIST SYSTEM (P100047/S033) | Medtronic | 2014-02-13 |
| VIBRANT SOUNDBRIDGE (P990052/S024) | Med-El Elektromedizinische Gerate GmbH | 2014-02-13 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S121) | Boston Scientific Scimed, Inc. | 2014-02-13 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S067) | Boston Scientific Corp | 2014-02-13 |
| CRYSTALENS ACCOMMODATING INTRAOCULAR LENS (IOL) AND TRULIGN TORIC POSTERIOR CHAMBER IOL (P030002/S029) | Bausch & Lomb, Inc. | 2014-02-13 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S108) | Boston Scientific Corp | 2014-02-13 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S087) | Boston Scientific Corp | 2014-02-13 |
| ION PACLITAXEL-ELUTING C ORONAY STENT SYSTEM (P100023/S084) | Boston Scientific Corp | 2014-02-13 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S054) | Boston Scientific Corp | 2014-02-13 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S068) | Boston Scientific Corp | 2014-02-13 |
| CHILLI COOLED ABLATION CATHETER AND CABLE (P980003/S046) | Boston Scientific Corp | 2014-02-13 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S034) | Edwards Lifesciences, LLC | 2014-02-12 |
| SYNVISC (P940015/S031) | Sanofi Genzyme Corp. | 2014-02-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S047) | Edwards Lifesciences, LLC | 2014-02-12 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM (P040036/S037) | Biosense Webster, Inc. | 2014-02-11 |
| BOND ORACLE HER2 IHC SYSTEM (P090015/S001) | Leica Biosystems | 2014-02-11 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM (P030031/S053) | Biosense Webster, Inc. | 2014-02-11 |
| PROPEL AND PROPEL MINI SINUS IMPLANTS (P100044/S015) | Intersect Ent. | 2014-02-11 |
| JUVEDERM VOLUMA XC (P110033/S003) | Allergan | 2014-02-11 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| INVENIA ABUS (P110006/S002) | GE Healthcare | 2014-02-11 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S034) | Allergan | 2014-02-11 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA (P030016/S026) | STAAR Surgical Company | 2014-02-10 |
| IMAGE CHECKER CAD (P970058/S026) | Hologic, Inc. | 2014-02-10 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S033) | Starr Surgical Co. | 2014-02-10 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM (P110042/S026) | Boston Scientific Corporation | 2014-02-07 |
| BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S052) | Boston Scientific | 2014-02-07 |
| NEUROPACE RNS SYSTEM (P100026/S003) | NeuroPace, Inc. | 2014-02-07 |
| ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB (P100010/S033) | Medtronic Cryocath, LP | 2014-02-07 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, ETRA SURGICAL CARDIAC CRYOABLATION DEVICE, MAX SURGICAL CARDIAC CRYOABLATION DEVI (P020045/S052) | Medtronic Cryocath, LP | 2014-02-07 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CARDIAC CRYOABALATION CATHETER (P100010/S034) | Medtronic Cryocath, LP | 2014-02-07 |
| FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE (P020045/S051) | Medtronic Cryocath, LP | 2014-02-07 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S045) | Endologix, LLC | 2014-02-06 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S085) | Boston Scientific Corp | 2014-02-06 |
| EXPRESS/EXPRESS2 MONORAIL AND OVER-THE-WIRE CONRONARY STENT SYSTEM (P020009/S116) | Boston Scientific Scimed, Inc. | 2014-02-06 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OTW) (P110010/S067) | Boston Scientific Corp | 2014-02-06 |
| FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S (P910023/S325) | ABBOTT MEDICAL | 2014-02-06 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S008) | Integra LifeSciences Corporation | 2014-02-06 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S083) | Boston Scientific Corp | 2014-02-06 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM (P110010/S066) | Boston Scientific Corp | 2014-02-06 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S (P030054/S256) | ABBOTT MEDICAL | 2014-02-06 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S034) | Medtronic | 2014-02-06 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE -WIRE) (P100023/S086) | Boston Scientific Corp | 2014-02-06 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S122) | Boston Scientific Scimed, Inc. | 2014-02-06 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S007) | Medtronic Vascular | 2014-02-05 |
| RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM (P110013/S024) | Medtronic Vascular | 2014-02-05 |
| COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA (P110040/S003) | Medtronic Vascular | 2014-02-05 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S053) | Medtronic, Inc. | 2014-02-05 |
| COMPLETE SE VASCULAR STENT SYSTEM-ILIAC (P090006/S013) | Medtronic Vascular | 2014-02-05 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S019) | Infusyn Therapeutics, LLC | 2014-02-04 |