| MOSIAC PORCINE BIOPROSTHESIS (P990064/S050) | Medtronic, Inc. | 2013-09-24 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S025) | Bunnell, Inc. | 2013-09-24 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S042) | Medtronic, Inc. | 2013-09-24 |
| PARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP (P980022/S137) | Medtronic Minimed | 2013-09-24 |
| ROTABLATOR ROTATIONAL ATHRECTOMY SYSTEM (P900056/S123) | Boston Scientific Corp | 2013-09-24 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S005) | KARL STORZ Endoscopy-America, Inc. | 2013-09-23 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CONONARY STENT SYSTEM (P070015/S111) | Abbott Vascular, Inc. | 2013-09-23 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S044) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S112) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S039) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW (P870077/S055) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S042) | Edwards Lifesciences, LLC | 2013-09-23 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S050) | Intera Oncology | 2013-09-23 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S061) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S026) | Edwards Lifesciences, LLC | 2013-09-23 |
| VNS THERAPY ACCESSORY PACK (P970003/S164) | LivaNova USA, Inc. | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S038) | Edwards Lifesciences, LLC | 2013-09-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S177) | Boston Scientific Corp | 2013-09-20 |
| CARPENTIER EDWARDS PERIMOUNT PERICARDIAL AOTRIC BIOPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS, RSRTHEON (P860057/S111) | Edwards Lifesciences, LLC | 2013-09-20 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S049) | Intera Oncology | 2013-09-20 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S178) | Boston Scientific Corp | 2013-09-20 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE (P110021/S025) | Edwards Lifesciences, LLC | 2013-09-20 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S213) | Medtronic, Inc. | 2013-09-19 |
| PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S303) | Boston Scientific | 2013-09-19 |
| MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM (P110040) | Medtronic Vascular | 2013-09-19 |
| NOVOTTF-100A SYSTEM (P100034/S006) | Novocure, GmbH | 2013-09-19 |
| PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S339) | Boston Scientific Corp | 2013-09-19 |
| SOFTEC HD INTRAOCULAR LENS (P090022/S019) | Lenstec, Inc. | 2013-09-19 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S035) | Baxter Healthcare Corp | 2013-09-19 |
| THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S022) | Boston Scientific Corp | 2013-09-18 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S080) | Medtronic, Inc. | 2013-09-18 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S067) | Medtronic, Ireland | 2013-09-18 |
| RESOLUTE INTEGRITY CORONARY STENT SYSTEM (P110013/S025) | Medtronic Vascular | 2013-09-18 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S004) | Medtronic, Ireland | 2013-09-18 |
| PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT (P100044/S011) | Intersect Ent. | 2013-09-18 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S104) | Advanced Bionics | 2013-09-18 |
| RADIESSE (P050037/S039) | Merz North America, Inc. | 2013-09-17 |
| ENTOTAK LEAD SYSTEM (P910073/S120) | Boston Scientific | 2013-09-17 |
| EASYTRAK AND ACUITY SPIRAL LEAD SYSTEM (P010012/S338) | Boston Scientific Corp | 2013-09-17 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S101) | Advanced Bionics | 2013-09-17 |
| PROMUS ELEMENT PLUS STENT SYSTEM (P110010/S059) | Boston Scientific Corp | 2013-09-17 |
| RADIESSE (P050052/S042) | Merz North America, Inc. | 2013-09-17 |
| BARD E-LUMINEXX VASCULAR STENT SYSTEM (P080007/S018) | Bard Peripheral Vascular, Inc. | 2013-09-17 |
| ACUITY STEERABLE LEAD SYSTEM (P050046/S020) | Guidant Corp. | 2013-09-17 |
| RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FO (P050052/S043) | Merz North America, Inc. | 2013-09-16 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S033) | Bard Peripheral Vascular | 2013-09-16 |
| ATTAIN BIPOLAR OTW LEAD (P010015/S209) | Medtronic, Inc. | 2013-09-16 |
| RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORARION AND OR/ CORRECTION OF THE SIGNS OF FACIAL FAT LO (P050037/S040) | Merz North America, Inc. | 2013-09-16 |
| MEDTRONIC DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S156) | Medtronic, Inc. | 2013-09-13 |
| PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S136) | Medtronic Minimed | 2013-09-13 |
| XIENCE XPEDITION EVEROLIMUS CORONARY STENT SYSTEM (P110019/S052) | Abbott Vascular | 2013-09-13 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S023) | Edwards Lifesciences, LLC | 2013-09-13 |
| BD FOCALPOINT SLIDE PROFILER (P950009/S015) | Bd Diagnostics | 2013-09-13 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S010) | Abbott Vascular, Inc. | 2013-09-13 |
| METHAFILCON LENSES: FREQUENCY 55 TORIC, FREQUENCY XED TORIC XR, FREQUENCY 55 TONIC XR. METHAFILCON LENSES: HYDROSOFT XWP (P850079/S065) | CooperVision, Inc. | 2013-09-13 |
| MAXUM (P010023/S010) | Ototronix, LLC | 2013-09-13 |
| TETRAFILCON LENSES: PREFERENCE SPHERE (N17679/S036) | CooperVision, Inc. | 2013-09-13 |
| REVO MRI IPG (P090013/S111) | Medtronic, Inc. | 2013-09-12 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S009) | Roche Molecular Systems, Inc. | 2013-09-12 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S028) | Medtronic Vascular | 2013-09-12 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S016) | Medtronic Vascular | 2013-09-12 |
| COBAS EGFR MUTATION TEST (P120019/S003) | Roche | 2013-09-12 |
| VIDAS TOTAL PSA (TPSA) ASSAY (P040008/S007) | bioMerieux, Inc. | 2013-09-12 |
| BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM; BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S020) | Ahp Eos Buyer, Inc. | 2013-09-12 |
| CONSULTA CRT-P , SYNCRA CRT-P (P010015/S214) | Medtronic, Inc. | 2013-09-12 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S032) | ETHICON, Inc. | 2013-09-12 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST (P050028/S035) | Roche Molecular Systems, Inc. | 2013-09-12 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST, V 2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S035) | Roche Molecular Systems, Inc. | 2013-09-12 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S009) | Roche Molecular Systems, Inc. | 2013-09-12 |
| COBAS HPV TEST (P100020/S011) | Roche Molecular Systems, Inc. | 2013-09-12 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S342) | Medtronic, Inc. | 2013-09-12 |
| THE BIOMET EBI BONE HEALING SYSTEM (P790002/S030) | Ahp Eos Buyer, Inc. | 2013-09-12 |
| COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S044) | Roche Molecular Systems, Inc. | 2013-09-12 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S051) | W. L. Gore & Associates, Inc. | 2013-09-10 |
| SPRINT QUATTRO LEAD, SPLITTER/ADAPTOR, DF-4 IMPLANT TOOL KIT FOR MDT LEADS (P920015/S108) | Medtronic, Inc. | 2013-09-10 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S023) | Allergan | 2013-09-10 |
| ABBOTT REAL TIME HBV (P080026/S008) | Abbott Molecular, Inc. | 2013-09-10 |
| FINELINE II STEROX LEAD (P960004/S060) | Boston Scientific | 2013-09-09 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S032) | Allergan | 2013-09-06 |
| COBAS EGFR MUTATION TEST (P120019/S002) | Roche | 2013-09-06 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S008) | Roche Molecular Systems, Inc. | 2013-09-06 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PRESSURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S034) | Roche Molecular Systems, Inc. | 2013-09-06 |
| BIOFINITY (P080011/S027) | CooperVision, Inc. | 2013-09-06 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST VERSION 2.0, COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S034) | Roche Molecular Systems, Inc. | 2013-09-06 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S021) | Ortho-Clinical Diagnostics | 2013-09-06 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S017) | Cryolife, Inc. | 2013-09-06 |
| ROTABLATOR ROTALLIN ADVANCER AND CATHETER (P900056/S125) | Boston Scientific Corp | 2013-09-06 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S008) | Roche Molecular Systems, Inc. | 2013-09-06 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S029) | Medtronic | 2013-09-06 |
| COBAS HPV TEST (P100020/S010) | Roche Molecular Systems, Inc. | 2013-09-06 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| ANTHEM RF CRT-PS (P030035/S112) | ABBOTT MEDICAL | 2013-09-05 |
| DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR (P970003/S165) | LivaNova USA, Inc. | 2013-09-05 |
| NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES (P990025/S038) | Biosense Webster, Inc. | 2013-09-05 |
| CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,,EZ STEER DS CATHETER (P950005/S045) | Biosense Webster, Inc. | 2013-09-05 |
| BIOSENSE WEBSTER CABLES (P990071/S024) | Biosense Webster, Inc. | 2013-09-05 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW) (P110013/S020) | Medtronic Vascular | 2013-09-05 |
| NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHE (P040036/S039) | Biosense Webster, Inc. | 2013-09-05 |
| CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER, (P010068/S035) | Biosense Webster, Inc. | 2013-09-05 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S107) | Boston Scientific Scimed, Inc. | 2013-09-05 |