| EXABLATE 2000/2100 (P110039/S004) | Insightec | 2013-12-17 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D IPG (P010031/S407) | Medtronic Cardiac Rhythm Disease Management | 2013-12-17 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S355) | Medtronic, Inc. | 2013-12-17 |
| PUNCTUA CRT-DS, COGNIS CRT-DS, ENERGEN CRT-D'S, INCEPTA CRT-DS (P010012/S344) | Boston Scientific Corp | 2013-12-17 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S015) | OraSure Technologies, Inc. | 2013-12-17 |
| ELLIPSE FAMILY OF ICDS (P910023/S321) | ABBOTT MEDICAL | 2013-12-17 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S412) | Medtronic Cardiac Rhythm Disease Management | 2013-12-17 |
| EVERA S DR ICD, EVERA VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S450) | Medtronic Cardiac Rhythm Disease Management | 2013-12-17 |
| BRAVA C RT-D; VIVA S CRT-D; VIVA XT CRT-D (P010031/S410) | Medtronic Cardiac Rhythm Disease Management | 2013-12-17 |
| EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD (P980016/S448) | Medtronic Cardiac Rhythm Disease Management | 2013-12-17 |
| PUNTUA ICD'S, TELIGEN ICD'S, ENERGEN ICD'S AND INCEPTA ICD'S (P960040/S308) | Boston Scientific | 2013-12-17 |
| CURRENT,CURRENT ACCEL,CURRENT +,ELLIPSE,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S324) | ABBOTT MEDICAL | 2013-12-17 |
| PROMOTE, PROMOTE ACCEL,PROMOTE Q, PROMOTE QUADRA,PROMOTE+,QUADRA ASSURA,UNIFY,UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S255) | ABBOTT MEDICAL | 2013-12-17 |
| BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D (P010031/S408) | Medtronic Cardiac Rhythm Disease Management | 2013-12-16 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S013) | Ventana Medical Systems, Inc. | 2013-12-16 |
| PATHWAY ANTI-C-KIT (9.7.) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S012) | Ventana Medical Systems, Inc. | 2013-12-16 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD (P980016/S446) | Medtronic Cardiac Rhythm Disease Management | 2013-12-16 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S023) | Boston Scientific Corporation | 2013-12-16 |
| COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS (P100020/S012) | Roche Molecular Systems, Inc. | 2013-12-16 |
| PATHWAY ANTI-HER2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S024) | Ventana Medical Systems, Inc. | 2013-12-16 |
| ATTAIN ABILITY LEAD (P080006/S061) | Medtronic, Inc. | 2013-12-16 |
| EXABLATE 2000/2100 (P040003/S013) | Insightec, Ltd. | 2013-12-16 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S048) | Integra LifeSciences Corporation | 2013-12-16 |
| SPRINT QUANTTRO LEAD (P920015/S124) | Medtronic, Inc. | 2013-12-16 |
| SELECTSURE LEAD (P030036/S067) | Medtronic Cardiac Rhythm Disease Management | 2013-12-16 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S084) | Medtronic, Inc. | 2013-12-15 |
| INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS (P030009/S071) | Medtronic, Ireland | 2013-12-15 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S030) | Medtronic Vascular | 2013-12-15 |
| ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S129) | Boston Scientific Corp | 2013-12-15 |
| ACTIVA PC (P960009/S186) | Medtronic, Inc. | 2013-12-13 |
| OCUFILCON D EXTENDED WEAR LENSES (P890023/S020) | The Cooper Companies | 2013-12-13 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S022) | Syncardia Systems, LLC | 2013-12-13 |
| RESTOREPRIME (P840001/S258) | Medtronic Neuromodulation | 2013-12-13 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S184) | Boston Scientific Corp | 2013-12-13 |
| BD PREPSTAIN SYSTEM (P970018/S029) | Bd Diagnostic Systems | 2013-12-13 |
| TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S007) | Endologix, LLC | 2013-12-13 |
| POLYMACON EXTENDED WEAR LENSES (P780007/S052) | CooperVision, Inc. | 2013-12-13 |
| INTERSTIM (P080025/S061) | Medtronic Neuromodulation | 2013-12-13 |
| SYNCHROMED II DUG INFUSION PUMP (P860004/S201) | Medtronic, Inc. | 2013-12-13 |
| INTERSTIM (P970004/S165) | Medtronic Neuromodulation | 2013-12-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEAD (P920015/S125) | Medtronic, Inc. | 2013-12-12 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S030) | Medtronic Vascular | 2013-12-12 |
| CAPSURE LEAD (P890003/S293) | Medtronic, Inc. | 2013-12-12 |
| ASSURANT COBALT (P110011/S005) | Medtronic, Ireland | 2013-12-12 |
| ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S025) | Medtronic Cryocath, LP | 2013-12-12 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S409) | Medtronic Cardiac Rhythm Disease Management | 2013-12-12 |
| TRANSVENE CS/SVC LEAD (P980050/S088) | Medtronic, Inc. | 2013-12-12 |
| MRICS AND LZ OCTAD LEAD FAMILIES (P840001/S257) | Medtronic Neuromodulation | 2013-12-12 |
| PROGENSA PCA3 ASSAY (P100033/S001) | Gen-Probe Incorporated | 2013-12-12 |
| RESOLUTE INTERGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM, RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM (P110013/S021) | Medtronic Vascular | 2013-12-12 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S070) | Medtronic, Ireland | 2013-12-12 |
| ENVEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S083) | Medtronic, Inc. | 2013-12-12 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S029) | Medtronic Vascular | 2013-12-12 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA CRT-D (P010031/S411) | Medtronic Cardiac Rhythm Disease Management | 2013-12-12 |
| EVERA S DR ICD, EVERA S VR, EVERA S VR ICD, EVERA XT DR ICD AND EVERA VR ICD (P980016/S449) | Medtronic Cardiac Rhythm Disease Management | 2013-12-12 |
| CAPSUREFIX LEAD (P930039/S097) | Medtronic, Inc. | 2013-12-12 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S055) | Medtronic, Inc. | 2013-12-12 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S022) | Boston Scientific Corporation | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S009) | Bio-Rad Laboratories | 2013-12-12 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S447) | Medtronic Cardiac Rhythm Disease Management | 2013-12-12 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S014) | Medtronic Vascular | 2013-12-12 |
| CAPSURE SENSE LEAD,VITATRON CRYSTALLINE LEAD (P830061/S101) | Medtronic Cardiac Rhythm Disease Management | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| RADIESSE (P050052/S047) | Merz North America, Inc. | 2013-12-11 |
| VERSATRAX PACING SYSTEM (P820003/S123) | Medtronic Cardiac Rhythm Disease Management | 2013-12-11 |
| DBS EXTENSIONS, DBS LEADS (P960009/S172) | Medtronic, Inc. | 2013-12-11 |
| ABBOTT REALTIME HBV ASSAY (P080026/S011) | Abbott Molecular, Inc. | 2013-12-11 |
| BAUSCH & LOMB SOFTLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES (P960022/S010) | Bausch & Lomb, Inc. | 2013-12-11 |
| ABBOTT REALTIME HCV ASSAY (P100017/S009) | Abbott Molecular, Inc. | 2013-12-11 |
| GENESYS HTA SYSTEM (P000040/S031) | Axora Medical, Inc. | 2013-12-11 |
| SNS URINARY EXTENSIONS, SNS URINARY LEADS (P970004/S156) | Medtronic Neuromodulation | 2013-12-11 |
| SYNERGYST II PACING SYSTEM (P890003/S281) | Medtronic, Inc. | 2013-12-11 |
| SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X 8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY, SCS SCREENING TRAIL (P840001/S241) | Medtronic Neuromodulation | 2013-12-11 |
| RADIESSE (P050037/S044) | Merz North America, Inc. | 2013-12-11 |
| SNS BOWEL EXTENSIONS, SNS BOWEL LEADS (P080025/S052) | Medtronic Neuromodulation | 2013-12-11 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S018) | Ferring Pharmaceuticals, Inc. | 2013-12-10 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S055) | Thoratec Laboratories Corp. | 2013-12-10 |
| BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S024) | Altacor , Ltd. | 2013-12-10 |
| PRECUSION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S183) | Boston Scientific Corp | 2013-12-10 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S020) | DePuy Orthopaedics, Inc. | 2013-12-09 |
| INFUSE BONE GRAFT (P000054/S040) | Medtronic Sofamor Danek USA, Inc. | 2013-12-06 |
| ADVISA DR MRI A2DR01 (P980035/S334) | Medtronic, Inc. | 2013-12-06 |
| INFUSE BONE GRAFT (P050053/S031) | Medtronic, Inc. | 2013-12-06 |
| SOF-SENSOR (P980022/S142) | Medtronic Minimed | 2013-12-06 |
| EASYTRAK 2,EASYTRAK 3,ACUITY SPIRAL CRTS (P010012/S343) | Boston Scientific Corp | 2013-12-06 |
| PROPEL AND PROPEL MINI SINUS IMPLANTS (P100044/S014) | Intersect Ent. | 2013-12-06 |
| JUVEDERM VOLUMA XC (P110033/S001) | Allergan | 2013-12-06 |
| REVO DR MRI RVDR01 (P090013/S105) | Medtronic, Inc. | 2013-12-06 |
| ACUITY STEERABLE CRTS (P050046/S022) | Guidant Corp. | 2013-12-06 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S054) | Medtronic Sofamor Danek USA, Inc. | 2013-12-06 |
| SOF-SENSOR (P980022/S145) | Medtronic Minimed | 2013-12-06 |
| ENLITE SENSOR (P120010/S002) | Medtronic, Inc. | 2013-12-06 |
| MED-EL COCHLEAR IMPLANT SYSTEM (P000025/S067) | Med-El Corp. | 2013-12-05 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S049) | Boston Scientific | 2013-12-05 |
| ATTAIN ABILITY LV LEAD (P080006/S057) | Medtronic, Inc. | 2013-12-05 |
| SYNVISC (P940015/S030) | Sanofi Genzyme Corp. | 2013-12-05 |
| PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM (P980022/S148) | Medtronic Minimed | 2013-12-05 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P980003/S045) | Boston Scientific Corp | 2013-12-05 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006) | W. L. Gore & Associates, Inc. | 2013-12-05 |