| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S100) | Boston Scientific Corp | 2014-06-04 |
| DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA, KINETRA AND SOLETRA FAMILIES (P960009/S188) | Medtronic, Inc. | 2014-06-04 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S052) | Cook, Inc. | 2014-06-04 |
| BARD ABLATION SYSTEM (P000020/S017) | Boston Scientific Corp | 2014-06-04 |
| SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P080025/S063) | Medtronic Neuromodulation | 2014-06-04 |
| PRECISION SPECTRA SYSTEM (P030017/S196) | Boston Scientific Corp | 2014-06-04 |
| NIRXCELL COCR CORNARY STENT ON RX (P110004/S006) | Medinol, Ltd. | 2014-06-04 |
| SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY (P970004/S167) | Medtronic Neuromodulation | 2014-06-04 |
| PUREVISION (BALAFILCON A) CONTACT LENS (P980006/S018) | Bausch & Lomb, Inc. | 2014-06-03 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S099) | Boston Scientific Corp | 2014-06-03 |
| PROMUS PREMIER & PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S087) | Boston Scientific Corp | 2014-06-03 |
| BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL (P080011/S029) | CooperVision, Inc. | 2014-06-03 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S002) | Highridge Medical, LLC | 2014-06-03 |
| MINIMED 530G INSULIN PUMP (P120010/S016) | Medtronic, Inc. | 2014-06-03 |
| DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S011) | Dexcom, Inc. | 2014-06-03 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S048) | Abbott Vascular | 2014-06-02 |
| ORIGEN, INOGEN,DYNAGEN, NG3 IMPLANTABLE CARDIOVESTER DEFIBRILLATOR (ICD) ORIGEN, INOGEN, DYNAGEN NG2.5 IMPLANTABLE CARDI (P960040/S317) | Boston Scientific | 2014-06-02 |
| ADAPTA, VERSA, SENSIA, IPG (P980035/S377) | Medtronic, Inc. | 2014-06-02 |
| TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM (P000023/S009) | Nexus CMF, LLC | 2014-06-02 |
| 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) (P890057/S022) | ZOLL Medical Corporation | 2014-06-02 |
| TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S009) | Nexus CMF, LLC | 2014-06-02 |
| NIRXCELL COCR CORONARY STENT ON RX (P110004/S004) | Medinol, Ltd. | 2014-06-02 |
| DYNAGEN, INOGEN, ORIGEN NG3 CARDIAC RESYNCHRONIZATION THERAPY DEFUBRILLATION DEFIBRILLATOR (CRT-D) (P010012/S356) | Boston Scientific Corp | 2014-06-02 |
| ARTUS CMV RGQ MDX KIT (P130027) | Qiagen, Inc. | 2014-06-02 |
| STAR, S41R EXCIMER LASER SYSTEM (P990010/S004) | Amo Manufacturing USA, LLC | 2014-05-30 |
| BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S058) | Boston Scientific | 2014-05-30 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S070) | Boston Scientific Corp | 2014-05-30 |
| BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT- (P010031/S445) | Medtronic Cardiac Rhythm Disease Management | 2014-05-30 |
| SUPARTZ (P980044/S018) | Seikagaku Corp. | 2014-05-30 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (P110042/S035) | Boston Scientific Corporation | 2014-05-30 |
| STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P990010/S006) | Amo Manufacturing USA, LLC | 2014-05-30 |
| STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P930016/S042) | Amo Manufacturing USA, LLC | 2014-05-30 |
| REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S030) | Smith & Nephew, Inc. | 2014-05-30 |
| GEL-ONE (P080020/S007) | Seikagaku Corp. | 2014-05-30 |
| STAR S4 IM EXCIMER LASER SYSTEM (P910062/S004) | Amo Manufacturing USA, LLC | 2014-05-30 |
| WAVESCAN WAVEFRONT SYSTEM (P930016/S040) | Amo Manufacturing USA, LLC | 2014-05-30 |
| NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM (P010013/S054) | Hologic, Inc. | 2014-05-30 |
| EVERA S DR ICD; S VR ICD; EVERA XT DR ICD; XT VR ICD; MAXIMO II ICD; PROTECTA ICD; XT ICD; SECURA ICD; VIRTUOSO II DR/VR (P980016/S483) | Medtronic Cardiac Rhythm Disease Management | 2014-05-30 |
| STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P910062/S006) | Amo Manufacturing USA, LLC | 2014-05-30 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S238) | Medtronic, Inc. | 2014-05-29 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S058) | ABBOTT MEDICAL | 2014-05-29 |
| BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S439) | Medtronic Cardiac Rhythm Disease Management | 2014-05-29 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S242) | ABBOTT MEDICAL | 2014-05-29 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD, MARQUIS (P980016/S478) | Medtronic Cardiac Rhythm Disease Management | 2014-05-29 |
| REVO MRI IPG (P090013/S141) | Medtronic, Inc. | 2014-05-29 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S265) | ABBOTT MEDICAL | 2014-05-29 |
| ADVISA DR IPG AND ADVISA DR MRI IPG (P980035/S376) | Medtronic, Inc. | 2014-05-29 |
| REVO MRI IPG (P090013/S139) | Medtronic, Inc. | 2014-05-29 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S034) | Boston Scientific Corporation | 2014-05-29 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S119) | Abbott Vascular, Inc. | 2014-05-29 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, (P110019/S060) | Abbott Vascular | 2014-05-29 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S239) | Medtronic, Inc. | 2014-05-29 |
| EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S035) | Bioventus, LLC | 2014-05-29 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S120) | ABBOTT MEDICAL | 2014-05-29 |
| PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S153) | Medtronic Minimed | 2014-05-29 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S088) | St. Jude Medical, Inc. | 2014-05-29 |
| MYCARELINK PATIENT MONITOR (P890003/S307) | Medtronic, Inc. | 2014-05-29 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG, ENPULSE E1 IPG,ENPULSE E2 IPG, KAPPA D(KAPPA 700)IPG, KAPPA D(K (P980035/S373) | Medtronic, Inc. | 2014-05-29 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL (P110042/S033) | Boston Scientific Corporation | 2014-05-28 |
| SYNTHES PRODISC-L TOTAL DISC REPLACEMENT (P050010/S014) | Centinel Spine, LLC | 2014-05-28 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S033) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S061) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| CAPSUREFIX MRI LEAD (P090013/S142) | Medtronic, Inc. | 2014-05-28 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045) | ABBOTT MEDICAL | 2014-05-28 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S038) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| INVIVE CRT PS, INTUA CRT PS (P030005/S109) | Guidant Corp. | 2014-05-28 |
| PUNCTUA ICDS, TELIGEN ICDS, ENERGEN ICDS, INCEPTA ICDS, ORIGEN ICDS, INOGEN ICDS, DYNAGEN ICDS (P960040/S314) | Boston Scientific | 2014-05-28 |
| LCS TOTAL KNEE SYSTEM (P830055/S144) | Depuy, Inc. | 2014-05-28 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S003) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S240) | Medtronic, Inc. | 2014-05-28 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S022) | DePuy Orthopaedics, Inc. | 2014-05-28 |
| CAPSURE FIX NOVUS LEAD. VITATRON CRYSTALLINE ACTICE FIXATION LEAD (P930039/S108) | Medtronic, Inc. | 2014-05-28 |
| GORE VIABAHN EDOPROSTHESIS (P040037/S063) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| ARCHITECT TOTAL PSA (P910007/S044) | Abbott Laboratories | 2014-05-28 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S094) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| ADVANTIO PACEMAKERS, INGENIO PACEMAKERS, VITALIO PACEMAKERS, FORMIO PACEMAKERS (N970003/S163) | Boston Scientific Corp | 2014-05-28 |
| PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-D,ORIGEN CRT-DS,DYNAGEN CRT-D (P010012/S353) | Boston Scientific Corp | 2014-05-28 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004/S006) | Ev3 Neurovascular | 2014-05-27 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S020) | Ferring Pharmaceuticals, Inc. | 2014-05-27 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S001) | Highridge Medical, LLC | 2014-05-27 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S037) | Baxter Healthcare Corp | 2014-05-27 |
| BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S025) | Altacor , Ltd. | 2014-05-27 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S333) | ABBOTT MEDICAL | 2014-05-25 |
| LCS TOTAL KNEE SYSTEM (P830055/S143) | Depuy, Inc. | 2014-05-23 |
| PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT (P100044/S016) | Intersect Ent. | 2014-05-23 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD (P980016/S479) | Medtronic Cardiac Rhythm Disease Management | 2014-05-23 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S237) | Medtronic, Inc. | 2014-05-23 |
| REVO MRI IPG (P090013/S138) | Medtronic, Inc. | 2014-05-23 |
| DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S194) | Medtronic, Inc. | 2014-05-23 |
| DYNAGEN,INOGEN,ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P960040/S315) | Boston Scientific | 2014-05-23 |
| ENDURANTSTENT GRAFT SYSTEM; ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AOTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM (P100021/S037) | Medtronic Vascular | 2014-05-23 |
| SCS NEUROSTIMULATORS IMPLAMTABLE RESTORE FAMILY (P840001/S268) | Medtronic Neuromodulation | 2014-05-23 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S335) | ABBOTT MEDICAL | 2014-05-23 |
| INVIVE, INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-PS) (P030005/S110) | Guidant Corp. | 2014-05-23 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES OF CRT-D DEVICES (P030054/S267) | ABBOTT MEDICAL | 2014-05-23 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S027) | Boston Scientific Corp | 2014-05-23 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S041) | Boston Scientific Corporation | 2014-05-23 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S440) | Medtronic Cardiac Rhythm Disease Management | 2014-05-23 |
| RESOLUTE INTEGRITY RX & OTW ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S040) | Medtronic Vascular | 2014-05-23 |
| BRAVA,CONCERTO II, MAXIMO II PRTECTA CRT-D,CONCERTO CONSULTA,INSYNC II PROTECT, INSYNC III MARQUIS , INSYNC MAXIMOICD (P010031/S438) | Medtronic Cardiac Rhythm Disease Management | 2014-05-23 |