| REGENT MECHANICAL HEART VALVE, STANDARD AND MASTERS MECHANICAL HEART VALVE (P810002/S091) | ABBOTT MEDICAL | 2014-12-15 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S019) | Edwards Lifesciences, LLC | 2014-12-15 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S021) | Mentor Corp. | 2014-12-15 |
| CURRENT ACCEL, CURRENT+ FAMILES OF ICD DEVICES (P910023/S349) | ABBOTT MEDICAL | 2014-12-15 |
| MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS (P990075/S030) | Mentor Worldwide, LLC | 2014-12-15 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S009) | Medtronic, Inc. | 2014-12-15 |
| X-STOP LTOS (P040001/S021) | Medtronic Sofamor Danek, Inc. | 2014-12-12 |
| REVO MRI IPG (P090013/S162) | Medtronic, Inc. | 2014-12-12 |
| PRODIGY IPG (P890003/S325) | Medtronic, Inc. | 2014-12-12 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S143) | Boston Scientific Corp | 2014-12-12 |
| DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S030) | Dexcom, Inc. | 2014-12-12 |
| SMARTABLATE SYSTEM (P990071/S030) | Biosense Webster, Inc. | 2014-12-12 |
| ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS (P010012/S378) | Boston Scientific Corp | 2014-12-12 |
| ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S401) | Medtronic, Inc. | 2014-12-12 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S008) | Bolton Medical, Inc. | 2014-12-12 |
| COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM (P970051/S124) | Cochlear Americas | 2014-12-12 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S339) | Boston Scientific | 2014-12-12 |
| MAXIMO II,PROTECTA,PROTECTA XT,SECURA AND VIRTUOSO II DR/VR ICDS (P980016/S510) | Medtronic Cardiac Rhythm Disease Management | 2014-12-12 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S113) | Advanced Bionics | 2014-12-12 |
| NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM (P970051/S125) | Cochlear Americas | 2014-12-12 |
| TRIFECTA VALVE (P100029/S018) | ABBOTT MEDICAL | 2014-12-12 |
| DUOVISC AND DISCOVISC (P840064/S058) | Alcon Laboratories | 2014-12-12 |
| CONCERTO II,CONSULTA,MAXIMO II,PROTECTA AND PROTECTA XT CRT-DS (P010031/S474) | Medtronic Cardiac Rhythm Disease Management | 2014-12-12 |
| PROVISC (P890047/S045) | Alcon Research, Ltd. | 2014-12-12 |
| ARCHITECT AUSAB (P050051/S028) | Abbott Laboratories, Inc. | 2014-12-11 |
| ELLIPSE/FORTIFY ASSURA FAMILY OS ICD'S (P910023/S346) | ABBOTT MEDICAL | 2014-12-11 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S127) | ABBOTT MEDICAL | 2014-12-11 |
| VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS (P000014/S028) | Ortho-Clinical Diagnostics, Inc. | 2014-12-11 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S024) | Integra LifeSciences Corporation | 2014-12-11 |
| ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S042) | Bayer Pharma AG | 2014-12-11 |
| ARCHITECT CORE (P080023/S026) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT FREE PSA (P980007/S037) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT HBSAG QUALITATIVE (P110029/S018) | Abbott Laboratories | 2014-12-11 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS (P880086/S249) | ABBOTT MEDICAL | 2014-12-11 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S052) | Medtronic | 2014-12-11 |
| ARCHITECT ANTI-HCV (P050042/S031) | Abbott Laboratories, Inc. | 2014-12-11 |
| ARCHITECT TOTAL PSA (P910007/S046) | Abbott Laboratories | 2014-12-11 |
| ARCHITECT CORE-M (P060035/S024) | Abbott Laboratories | 2014-12-11 |
| QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S276) | ABBOTT MEDICAL | 2014-12-11 |
| ARCHITECT AFP (P120008/S007) | Abbott Laboratories | 2014-12-11 |
| FINELINE II STEROID-ELUTING PACING LEADS (P960004/S067) | Boston Scientific | 2014-12-11 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S093) | Medtronic, Inc. | 2014-12-10 |
| ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS (P080006/S073) | Medtronic, Inc. | 2014-12-10 |
| ABBOTT REALTIME HCV ASSAY (P100017/S011) | Abbott Molecular, Inc. | 2014-12-10 |
| ABBOTT REALTIME HVB ASSAY (P080026/S013) | Abbott Molecular, Inc. | 2014-12-10 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S013) | Medtronic Vascular, Inc. | 2014-12-10 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S047) | Medtronic Vascular | 2014-12-10 |
| THINPREP PROCESSORS (P950039/S032) | Hologic, Inc. | 2014-12-10 |
| QUANTIFERON-TB GOLD TEST (P010033/S026) | Qiagen | 2014-12-10 |
| REALTIME HCV GENOTYPE II (P120012/S006) | Abbott Molecular | 2014-12-10 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S007) | Abbott Molecular, Inc. | 2014-12-10 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S008) | Medtronic, Inc. | 2014-12-10 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S007) | Biomet Microfixation, Inc. | 2014-12-09 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S102) | Boston Scientific Corp | 2014-12-08 |
| AMS 800TM URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S051) | Boston Scientific Corp | 2014-12-08 |
| ARCHITECT TOTAL PSA (LN 6CO6) (P910007/S047) | Abbott Laboratories | 2014-12-08 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S062) | Boston Scientific Corp | 2014-12-08 |
| BLAZER II XP CARDIAC ABLATION CATHETER (P020025/S061) | Boston Scientific | 2014-12-08 |
| CELSIUS ELECTROPHYSIOLOGY CATHETER (P950005/S055) | Biosense Webster, Inc. | 2014-12-08 |
| AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT (N970012/S099) | Boston Scientific Corp | 2014-12-08 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S089) | Boston Scientific Corp | 2014-12-08 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S078) | Med-El Corp. | 2014-12-08 |
| EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S038) | Bioventus, LLC | 2014-12-08 |
| RESTYLANE, PERLANE, RESTYLANE L, PERLANE L, RESTYLANE SILK INJECTABLE GELS (P040024/S076) | Q-Med AB | 2014-12-08 |
| LCS TOTAL KNEE SYSTEM (P830055/S150) | Depuy, Inc. | 2014-12-08 |
| NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S043) | Biosense Webster, Inc. | 2014-12-08 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S139) | Boston Scientific Corp | 2014-12-08 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S038) | Abbott Laboratories | 2014-12-08 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S053) | Boston Scientific Corp | 2014-12-08 |
| NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CELSIUS THERMOCOOL ELECTROPHYSIOLOGY CATHETER (P030031/S064) | Biosense Webster, Inc. | 2014-12-08 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S125) | Boston Scientific Scimed, Inc. | 2014-12-08 |
| BLAZER II CARDIAC ABLATION CATHETER (P920047/S073) | Boston Scientific Corp | 2014-12-08 |
| NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S044) | Biosense Webster, Inc. | 2014-12-08 |
| ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S031) | Beckman Coulter, Inc. | 2014-12-08 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S131) | Boston Scientific Scimed, Inc. | 2014-12-08 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S043) | Allergan | 2014-12-05 |
| ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS (P840001/S273) | Medtronic Neuromodulation | 2014-12-05 |
| NOVAFLEX + DELIVERY SYSTEM (P130009/S017) | Edwards Lifesciences, LLC | 2014-12-05 |
| ACTIVA DEEP BRAIN STIMULATION SYSTEM (P960009/S197) | Medtronic, Inc. | 2014-12-05 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, GUARDIAN REAL-TIME MONITOR (P980022/S172) | Medtronic Minimed | 2014-12-05 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S042) | Gynecare, Inc. | 2014-12-04 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S031) | Ventana Medical Systems, Inc. | 2014-12-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S509) | Medtronic Cardiac Rhythm Disease Management | 2014-12-04 |
| QUANTIFERON- TB GOLD TEST (P010033/S025) | Qiagen | 2014-12-04 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S051) | Medtronic | 2014-12-04 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S016) | Ventana Medical Systems, Inc. | 2014-12-04 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0, COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S050) | Roche Molecular Systems, Inc. | 2014-12-04 |
| DISPOSABLE FALOPE RING BAND APPLICATOR KITS (P870076/S015) | Gyrus Acmi, Inc. | 2014-12-04 |
| CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS) (P030002/S032) | Bausch & Lomb, Inc. | 2014-12-04 |
| INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S020) | Ventana Medical Systems, Inc. | 2014-12-04 |
| ARTIFICIAL PANCREAS DEVICE SYSTEM (P120010/S045) | Medtronic, Inc. | 2014-12-04 |
| MINILINK REAL-TIME TRASMITTER, IPRO2 DIGITAL RECORDER (P980022/S164) | Medtronic Minimed | 2014-12-04 |
| BRAVA CRT-D'S BRAVA QUAD CRT-D'S, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S473) | Medtronic Cardiac Rhythm Disease Management | 2014-12-04 |
| MINIMED 530G INSULIN PUMPS (P120010/S043) | Medtronic, Inc. | 2014-12-03 |
| SETROX S LEAD, DEXTRUS, TILDA R, SAFIO S. (P950037/S145) | Biotronik, Inc. | 2014-12-03 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMPS (P980022/S170) | Medtronic Minimed | 2014-12-03 |
| SEN-SERTER (P980022/S171) | Medtronic Minimed | 2014-12-03 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S045) | Medtronic Heart Valves | 2014-12-02 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S049) | Medtronic, Inc. | 2014-12-02 |