| CRYOABLATION CONSOLE (P020045/S046) | Medtronic Cryocath, LP | 2014-03-06 |
| MINIMED 530G INSULIN PUMPS; ENLITE SENSOR (P120010/S010) | Medtronic, Inc. | 2014-03-06 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S428) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S113) | Cochlear Americas | 2014-03-05 |
| BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D (P010031/S417) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S052) | Dexcom, Inc. | 2014-03-05 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S041) | Boston Scientific Corp | 2014-03-05 |
| EVERA S DR ID, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S466) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S455) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S014) | Dexcom, Inc. | 2014-03-05 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORNARY STENT SYSTEM (P110013/S034) | Medtronic Vascular | 2014-03-04 |
| 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/S426) | Medtronic Cardiac Rhythm Disease Management | 2014-03-04 |
| CERVISTA HPV HR TEST (P080014/S019) | Hologic, Inc. | 2014-03-04 |
| CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S330) | ABBOTT MEDICAL | 2014-03-04 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S261) | ABBOTT MEDICAL | 2014-03-04 |
| INTEGRITY CORONARY STENT STYSTEMS (P030009/S074) | Medtronic, Ireland | 2014-03-04 |
| COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 (P060030/S039) | Roche Molecular Systems, Inc. | 2014-03-04 |
| 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 (P980016/S464) | Medtronic Cardiac Rhythm Disease Management | 2014-03-04 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S (P030054/S260) | ABBOTT MEDICAL | 2014-03-04 |
| ANTHEM FAMILY OF CRT-P DEVICES (P030035/S117) | ABBOTT MEDICAL | 2014-03-04 |
| IDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE (P880086/S239) | ABBOTT MEDICAL | 2014-03-04 |
| CERVISTA HPV 16/18 TEST (P080015/S010) | Hologic, Inc. | 2014-03-04 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S088) | Medtronic, Inc. | 2014-03-04 |
| FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS (P910023/S329) | ABBOTT MEDICAL | 2014-03-04 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S004) | Medtronic Vascular | 2014-02-28 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S053) | Abbott Vascular | 2014-02-28 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM (P110010/S072) | Boston Scientific Corp | 2014-02-27 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S462) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) INVIVE AND INTUA MODELS (P030005/S105) | Guidant Corp. | 2014-02-27 |
| REVO MRI IPG (P090013/S124) | Medtronic, Inc. | 2014-02-27 |
| MYCARELINK PATIENT MONITOR (P890003/S299) | Medtronic, Inc. | 2014-02-27 |
| ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP (P980016/S454) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S233) | Medtronic, Inc. | 2014-02-27 |
| FORMIO, VITALIO, ADVANTIO, INGENIO-- PACEMAKER (N970003/S158) | Boston Scientific Corp | 2014-02-27 |
| PARADYM VR 8750,PARADYM DR8750,PARADYM RF CRT-D9750 (P980049/S092) | MicroPort CRM USA, Inc. | 2014-02-27 |
| SELECTSECURE LEAD FAMILY (P030036/S070) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| PARADYM CRT-D 8750; PARADYM RF CRT-D9750 (P060027/S058) | MicroPort CRM USA, Inc. | 2014-02-27 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD) (P990023/S012) | Alcon Laboratories | 2014-02-27 |
| MYCARELINK MONITOR, (P890003/S295) | Medtronic, Inc. | 2014-02-27 |
| REVO MRI IPG (P090013/S130) | Medtronic, Inc. | 2014-02-27 |
| INSYNC II PROTECT ICD, INSYNC III MARQUIS ICD,INSYNC MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,CONCERTO ICD,CONCERTO II (P010031/S416) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD (P830061/S107) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| SPRINT QUATTRO LEAD FAMILY (P920015/S129) | Medtronic, Inc. | 2014-02-27 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S010) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-02-27 |
| EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S460) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| EPICARDIAL PATCH LEAD FAMILY (P900061/S127) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| ADAPTA, VERA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S (P980035/S365) | Medtronic, Inc. | 2014-02-27 |
| TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS (P990027/S019) | Technolas Perfect Vision GmbH | 2014-02-27 |
| INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD (P010015/S217) | Medtronic, Inc. | 2014-02-27 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE (P010031/S413) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S087) | MicroPort CRM USA, Inc. | 2014-02-27 |
| PRMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (CMS) (P110010/S074) | Boston Scientific Corp | 2014-02-27 |
| ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700) (P980035/S360) | Medtronic, Inc. | 2014-02-27 |
| EVERA S DR/S VR ICD'S, EVERA XT DR/VR ICD'S, MAXIMO II ICD, PROTECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR IC (P980016/S461) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PHATINUM CHROMIUM CORONARY STENT SYSTEM- (MES) (P110010/S073) | Boston Scientific Corp | 2014-02-27 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S069) | Boston Scientific Corp | 2014-02-27 |
| RADIESSE DERMAL FILLER (P050037/S046) | Merz North America, Inc. | 2014-02-27 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S424) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S151) | Medtronic Minimed | 2014-02-27 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (P980049/S091) | MicroPort CRM USA, Inc. | 2014-02-27 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D9750 (P060027/S059) | MicroPort CRM USA, Inc. | 2014-02-27 |
| CAPSUREFIX LEAD; CAPSUREFIX NOVIS LEAD, SUREFIX LEAD (P930039/S104) | Medtronic, Inc. | 2014-02-27 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S071) | Boston Scientific Corp | 2014-02-27 |
| ARISTA AH ABSORRBABLE HEMOSTAT (P050038/S019) | Davol, Inc. | 2014-02-27 |
| ADAPTA, VERSA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S (P980035/S366) | Medtronic, Inc. | 2014-02-27 |
| BRAVA CRT-D, CONCERTA II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA/PROTECTA XT CRT-D S/VIVA XT CRT-D (P010031/S422) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CAPSURE LEAD (P890003/S302) | Medtronic, Inc. | 2014-02-27 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRT (P010031/S423) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD (P850089/S106) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD, VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE (P980016/S451) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S229) | Medtronic, Inc. | 2014-02-27 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S058) | Medtronic, Inc. | 2014-02-27 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S070) | Boston Scientific Corp | 2014-02-27 |
| REVO MRI IPG (P090013/S131) | Medtronic, Inc. | 2014-02-27 |
| RADIESSE DERMAL FILLER (P050052/S050) | Merz North America, Inc. | 2014-02-27 |
| MINIMED 530G INSULIN PUMP (P120010/S009) | Medtronic, Inc. | 2014-02-27 |
| CAPSUREFIX MRI LEAD (P090013/S129) | Medtronic, Inc. | 2014-02-27 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S057) | ABBOTT MEDICAL | 2014-02-26 |
| SOLESTA (P100014/S011) | Palette Life Sciences | 2014-02-26 |
| SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S087) | St. Jude Medical, Inc. | 2014-02-26 |
| AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S237) | ABBOTT MEDICAL | 2014-02-26 |
| DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM (P120005/S013) | Dexcom, Inc. | 2014-02-26 |
| BD FOCAL POINT SLIDE PROFILER (P950009/S017) | Bd Diagnostics | 2014-02-26 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S033) | Medtronic Vascular | 2014-02-26 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY PF CRT-DS (P030054/S254) | ABBOTT MEDICAL | 2014-02-26 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S115) | ABBOTT MEDICAL | 2014-02-26 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S323) | ABBOTT MEDICAL | 2014-02-26 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S038) | Medtronic Vascular | 2014-02-26 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S016) | Medtronic Vascular | 2014-02-26 |
| MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS (P860004/S202) | Medtronic, Inc. | 2014-02-25 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S189) | Boston Scientific Corp | 2014-02-25 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S052) | Hologic, Inc. | 2014-02-25 |
| NEUROPACE RNS SYSTEM (P100026/S010) | NeuroPace, Inc. | 2014-02-25 |
| MONOVISC (P090031) | Anika Therapeutics, Inc. | 2014-02-25 |
| NEUROPACE RNS SYSTEM (P100026/S004) | NeuroPace, Inc. | 2014-02-24 |
| MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S013) | Mentor Corp. | 2014-02-24 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S039) | Gynecare, Inc. | 2014-02-24 |
| NEXGEN LPS-FLEX / LPS-MOBILE BEARING KNEES (P060037/S029) | Zimmer, Inc. | 2014-02-21 |
| MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS (P110009/S004) | Highridge Medical, LLC | 2014-02-21 |
| COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES (P850079/S063) | CooperVision, Inc. | 2014-02-21 |