| THERASCREEN KRAS RGQ PCR KIT (P110027/S003) | QIAGEN GmbH | 2015-01-16 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S048) | Vistakon, Division of Johnson & Johnson Vision Car | 2015-01-16 |
| MEMORYGEL BREAST IMPLANT (P030053/S019) | Mentor Corp. | 2015-01-16 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S005) | QIAGEN GmbH | 2015-01-16 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S287) | Medtronic Neuromodulation | 2015-01-16 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S018) | Roche Molecular Systems, Inc. | 2015-01-15 |
| SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS (P090022/S024) | Lenstec, Inc. | 2015-01-15 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S004) | QIAGEN GmbH | 2015-01-15 |
| LIVEWIRE TC ABLATION CATHETERS (P960016/S052) | St Jude Medical | 2015-01-15 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S012) | Roche Molecular Systems, Inc. | 2015-01-15 |
| THERASCREEN KRAS RGQ PCR KIT (P110027/S002) | QIAGEN GmbH | 2015-01-15 |
| REBEL MONORAIL AND OVER-THE-WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S008) | Boston Scientific Corp | 2015-01-15 |
| CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP (P890055/S059) | Intera Oncology | 2015-01-15 |
| COBAS EGFR MUTATION TEST (P120019/S005) | Roche | 2015-01-15 |
| INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S066) | Boston Scientific | 2015-01-15 |
| COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S052) | Roche Molecular Systems, Inc. | 2015-01-15 |
| COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 (P060030/S044) | Roche Molecular Systems, Inc. | 2015-01-14 |
| MAESTRO RECHARGEABLE SYSTEM (P130019) | Reshape Lifesciences, Inc. | 2015-01-14 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM,PROMUS PREMIER EVEROLIMUS-ELUTING PLATINU (P110010/S101) | Boston Scientific Corp | 2015-01-14 |
| TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S017) | Endologix, LLC | 2015-01-14 |
| KONING BREAST CT (MODEL CBCT1000) (P130025) | Koning Corporation | 2015-01-14 |
| COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S051) | Roche Molecular Systems, Inc. | 2015-01-14 |
| MINI-MED 530G INSULIN PUMP (P120010/S051) | Medtronic, Inc. | 2015-01-14 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S043) | Roche Molecular Systems, Inc. | 2015-01-14 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S017) | Roche Molecular Systems, Inc. | 2015-01-14 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S112) | Boston Scientific Corp | 2015-01-14 |
| PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSLIN PUMP (P980022/S175) | Medtronic Minimed | 2015-01-14 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S007) | Boston Scientific Corp | 2015-01-14 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S023) | Mentor Corp. | 2015-01-13 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S278) | ABBOTT MEDICAL | 2015-01-13 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S251) | ABBOTT MEDICAL | 2015-01-13 |
| ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S (P910023/S348) | ABBOTT MEDICAL | 2015-01-13 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S011) | Cook Ireland, Ltd. | 2015-01-13 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S129) | ABBOTT MEDICAL | 2015-01-13 |
| THINPREP IMAGING SYSTEM (P020002/S009) | Hologic, Inc. | 2015-01-12 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S005) | Cardiva Medical, Inc. | 2015-01-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T (P860057/S130) | Edwards Lifesciences, LLC | 2015-01-12 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S006) | Abbott Vascular (Idef Technologies Inc) | 2015-01-09 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S060) | Cordis US Corporation | 2015-01-09 |
| COMFILCON A EXTENDED WEAR-LENSES (P080011/S028) | CooperVision, Inc. | 2015-01-09 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S340) | Boston Scientific | 2015-01-09 |
| OCUFILCON D EXTENDED-WEAR LENSES (P890023/S021) | The Cooper Companies | 2015-01-09 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S008) | Cardiva Medical, Inc. | 2015-01-09 |
| POLYMACON EXTENDED-WEAR LENSES (P780007/S053) | CooperVision, Inc. | 2015-01-09 |
| THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S061) | Cordis US Corporation | 2015-01-09 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S381) | Boston Scientific Corp | 2015-01-09 |
| SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS (P910001/S076) | Spectranetics Corp. | 2015-01-08 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S014) | W. L. Gore & Associates, Inc. | 2015-01-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S074) | W. L. Gore & Associates, Inc. | 2015-01-08 |
| SPECTRANETICS LASER SHEATHS (SLS) (P960042/S051) | Spectranetics (Philips) | 2015-01-08 |
| ZILVER FLEX 35 VASCULAR STENT (P050017/S009) | Cook Ireland, Ltd. | 2015-01-07 |
| ENLITE GLUCOSE SENSORS (P120010/S050) | Medtronic, Inc. | 2015-01-07 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S075) | Spectranetics Corp. | 2015-01-07 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S039) | Coloplast Corp. | 2015-01-07 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S010) | Cook Ireland, Ltd. | 2015-01-07 |
| SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID) (P030050/S022) | Q-Med AB | 2015-01-06 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA,ORIGEN, INOGEN, DYNAGEN, AUTOGEN, (CRT-D RESYNCHRONIZATION DEVICES (P010012/S377) | Boston Scientific Corp | 2015-01-06 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S008) | Medtronic, Ireland | 2015-01-06 |
| LATITUDE CONSULT SYSTEM (P910077/S148) | Boston Scientific | 2015-01-06 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S096) | MicroPort CRM USA, Inc. | 2015-01-06 |
| DYNAGEN, INOGEN, ORIGEN ICDS (P960040/S341) | Boston Scientific | 2015-01-06 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S039) | W. L. Gore & Associates, Inc. | 2015-01-06 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (PACEMAKER DEVICES) (N970003/S169) | Boston Scientific Corp | 2015-01-06 |
| CAPSUREFIX NOVUS LEAD AND VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S122) | Medtronic, Inc. | 2015-01-06 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES (P960040/S337) | Boston Scientific | 2015-01-06 |
| DYNAGEN, INOGEN, ORIGEN CRT-DS (P010012/S382) | Boston Scientific Corp | 2015-01-06 |
| INVIVE, INLIVEN, INTUA, VALITUDE, VALITUDE X4 (CRT-P RESYNCHRONIZATION DEVICES (P030005/S115) | Guidant Corp. | 2015-01-06 |
| PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM (P980022/S174) | Medtronic Minimed | 2015-01-02 |
| MINIMED 530G SYSTEM AND MINILINK REAL-TIME SYSTEM (P120010/S049) | Medtronic, Inc. | 2015-01-02 |