| ENLITE GLUCOSE SENSOR (P120010/S025) | Medtronic, Inc. | 2014-07-02 |
| SURGIFOAM ABSORBABLE GELATINE SPONGE, USP (P990004/S024) | Ferrosan Meidcal Devices A/S | 2014-07-02 |
| SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION) (P990071/S027) | Biosense Webster, Inc. | 2014-07-02 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S008) | Medtronic Vascular, Inc. | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S066) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S066) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S039) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| SNS URINARY VERIFY SCREENING TRAILING SYSTEMS (INCLUDING TEMPORARY LEADS) (P970004/S176) | Medtronic Neuromodulation | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S067) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S041) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S101) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S099) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S007) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S035) | Neomend, Inc. | 2014-07-02 |
| EON CHARGING SYSTEM (P010032/S075) | ABBOTT MEDICAL | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S100) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC) (P970003/S169) | LivaNova USA, Inc. | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S036) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S008) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S040) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHERTERS (P100010/S036) | Medtronic Cryocath, LP | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S037) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S009) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S098) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| CELSIUS CATHETER, CELSIUS RMT CATHETER (P950005/S050) | Biosense Webster, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S069) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S006) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S034) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S068) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S063) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S042) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| RESTORESENSOR RECHARGEABLE NEUROSTIMULATOR; RESTORESENSOR SURESCAN MRI RECHARGEABLE NEUROSTIMULATOR (P840001/S270) | Medtronic Neuromodulation | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S065) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S035) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S024) | Syncardia Systems, LLC | 2014-07-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S064) | W. L. Gore & Associates, Inc. | 2014-07-02 |
| SNS BOWEL VERIFY SCREENING TRAILING SYSTEM (INCLUDING TEMPORATY LEADS) (P080025/S072) | Medtronic Neuromodulation | 2014-07-02 |
| CELSIUS DS CATHETER, NAVISTAR DS CATHETER (P010068/S039) | Biosense Webster, Inc. | 2014-07-02 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S002) | Cochlear Americas | 2014-07-01 |
| NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT THERMOCOOL D-1302 XX (P030031/S044) | Biosense Webster, Inc. | 2014-07-01 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM (P060001/S021) | Medtronic Vascular, Inc. | 2014-07-01 |
| NAVISTAR RMT THERMOCOOL CATHETER (P040036/S032) | Biosense Webster, Inc. | 2014-07-01 |
| RESTYLANE/PERLANE, RESTYLANE-L/PERLANE-L INJECTABLE GELS (P040024/S075) | Q-Med AB | 2014-07-01 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S009) | Medtronic Vascular, Inc. | 2014-07-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTINGPLATINUM CHROMIUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM (P110010/S088) | Boston Scientific Corp | 2014-06-30 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S033) | Boston Scientific Corporation | 2014-06-30 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S021) | Dexcom, Inc. | 2014-06-30 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S130) | Boston Scientific Scimed, Inc. | 2014-06-30 |
| PRODIGY IPG (P890003/S310) | Medtronic, Inc. | 2014-06-30 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S101) | Boston Scientific Corp | 2014-06-30 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| CVX-300 & CVX-300P EXCIMER LASER SYSTEM (P910001/S071) | Spectranetics Corp. | 2014-06-30 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S097) | W. L. Gore & Associates, Inc. | 2014-06-30 |
| VARIOUS MODELS OF SLX LEADS AND VARIOUS MODELS OF SELOX,DEXTRUS,AND SAFIO DRUG ELUTING LEADS (P950037/S134) | Biotronik, Inc. | 2014-06-30 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S124) | Boston Scientific Scimed, Inc. | 2014-06-30 |
| ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES (P910073/S126) | Boston Scientific | 2014-06-30 |
| VARIOUS MODELS OF COROX, CELERITY AND LV LEADS (P070008/S051) | Biotronik, Inc. | 2014-06-30 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S061) | Boston Scientific Corp | 2014-06-30 |
| KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS (P980023/S058) | Biotronik, Inc. | 2014-06-30 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S379) | Medtronic, Inc. | 2014-06-30 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S175) | Medtronic Neuromodulation | 2014-06-27 |
| PARADYM CRT-D & PARADYM RF CRT-D (P060027/S064) | MicroPort CRM USA, Inc. | 2014-06-27 |
| PARADYM RF VR 9250, VR9250, PARADYM RF DR 9550 (P980049/S098) | MicroPort CRM USA, Inc. | 2014-06-27 |
| ETI-MAK-2 PLUS ASSAY (P990038/S020) | DiaSorin, Inc. | 2014-06-27 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S037) | Boston Scientific Corporation | 2014-06-27 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S017) | DiaSorin, Inc. | 2014-06-27 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S051) | Boston Scientific Corp | 2014-06-27 |
| ETI-EBK PLUS ASSAY (P990043/S020) | DiaSorin, Inc. | 2014-06-27 |
| DRUG DELIVERY INFUSION (P860004/S207) | Medtronic, Inc. | 2014-06-27 |
| ETI-AB-COREK PLUS ASSAY (P990045/S017) | DiaSorin, Inc. | 2014-06-27 |
| SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY (P840001/S269) | Medtronic Neuromodulation | 2014-06-27 |
| SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P080025/S071) | Medtronic Neuromodulation | 2014-06-27 |
| PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS (P980049/S097) | MicroPort CRM USA, Inc. | 2014-06-27 |
| DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S195) | Medtronic, Inc. | 2014-06-27 |
| TRULIGN TORIC POSTER CHAMBER INTRAOCULAR LENS (P030002/S028) | Bausch & Lomb, Inc. | 2014-06-27 |
| OCTRODE LEADS (P010032/S080) | ABBOTT MEDICAL | 2014-06-27 |
| SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S039) | Boston Scientific Corporation | 2014-06-27 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S044) | Medtronic | 2014-06-27 |
| ETI-AB-AUK-PLUS (P990042/S016) | DiaSorin, Inc. | 2014-06-27 |
| ETI-AB-EBK PLUS ASSAY (P990041/S019) | DiaSorin, Inc. | 2014-06-27 |
| PARADYM RF CRT-D9750 (P060027/S065) | MicroPort CRM USA, Inc. | 2014-06-27 |
| AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE (P800002/S021) | C.R. Bard, Inc. | 2014-06-26 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S020) | Syncardia Systems, LLC | 2014-06-26 |
| AVITENE MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE (N17600/S029) | Davol Inc., Sub. C. R. Bard, Inc. | 2014-06-26 |
| RESTYLANE, PERLANE, RESTYLANE L, PERLANE L (P040024/S074) | Q-Med AB | 2014-06-25 |
| MICRONY CRT-P'S (P970013/S059) | ABBOTT MEDICAL | 2014-06-25 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S (P910023/S337) | ABBOTT MEDICAL | 2014-06-25 |
| ACCENT, VERITY, IDENTITY, ZEPHYR, ASSURITY/+, ENDURITY CRT-P'S (P880086/S243) | ABBOTT MEDICAL | 2014-06-25 |
| PROMOTE+,UNIFY,UNIFY ASSURA,UNIFY QUADRA, & QUADRA ASSURA CRT-DS (P030054/S269) | ABBOTT MEDICAL | 2014-06-25 |
| ANTHEM AND ALLURE CRT-P'S (P030035/S121) | ABBOTT MEDICAL | 2014-06-25 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S077) | Med-El Corp. | 2014-06-24 |
| JUVEDERM VOLUMA XC,JUVEDERM HYALURONATE GEL IMPLANTS (P110033/S009) | Allergan | 2014-06-24 |
| FREEDOM SOLO STENTLESS HEART VALVE (P130011) | Corcym Canada Corp | 2014-06-24 |
| STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE (P000046/S024) | Anika Therapeutics, Inc. | 2014-06-24 |
| JUVEDERM HYALURONATE GEL IMPLANTS, JUVEDERN VOLUMA XC (P050047/S038) | Allergan | 2014-06-24 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S006) | Medtronic Vascular, Inc. | 2014-06-22 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S262) | ABBOTT MEDICAL | 2014-06-20 |
| LUMAX FAMILIES OF ICD'S & CRT-D'S, ILESTO & IFORNIA FAMILIES OF ICD'S & CRT-D'S (P050023/S072) | Biotronik, Inc. | 2014-06-20 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S404) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| LUMOS FAMILY OF ICD'S (P000009/S056) | Biotronik, Inc. | 2014-06-20 |