| SILSOFT(ELASTOFILCON A) CONTACT LENS (P850068/S011) | Bausch & Lomb, Inc. | 2014-05-08 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S002) | Highridge Medical, LLC | 2014-05-08 |
| DEFLUX INJECTABLE GEL (P000029/S076) | Palette Life Sciences | 2014-05-08 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S110) | Cochlear Americas | 2014-05-08 |
| THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY (P040044/S055) | Cordis US Corporation | 2014-05-08 |
| TRIFECTA VALVE (P100029/S015) | ABBOTT MEDICAL | 2014-05-08 |
| MINIMED 530G INSULIN PUMP (P120010/S020) | Medtronic, Inc. | 2014-05-08 |
| THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS (P960004/S065) | Boston Scientific | 2014-05-07 |
| NEUROPACE RNS SYSTEM (P100026/S011) | NeuroPace, Inc. | 2014-05-07 |
| VENTAK P2 AICD SYSTEM (P930035/S026) | Boston Scientific | 2014-05-07 |
| RADIESSE DERMAL FILLER (P050052/S053) | Merz North America, Inc. | 2014-05-07 |
| COLLACOTE,COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND GRESSING FOR DENTAL SURGERY (P840062/S039) | Integra Lifesciences Corp. | 2014-05-07 |
| AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM (P830060/S079) | Boston Scientific | 2014-05-07 |
| CARDIOGENESIS TMR SYSTEM (P970029/S026) | Cryolife, Inc. | 2014-05-07 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S052) | Integra LifeSciences Corporation | 2014-05-07 |
| VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM (P940031/S077) | Boston Scientific | 2014-05-07 |
| VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK (P910077/S142) | Boston Scientific | 2014-05-07 |
| RADIESSE DERMAL FILLER (P050037/S048) | Merz North America, Inc. | 2014-05-07 |
| FLEXTEND PACING LEADS AND FIXATION TOOL (P960006/S042) | Boston Scientific | 2014-05-07 |
| RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS (P940008/S031) | Boston Scientific | 2014-05-07 |
| CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD (P010012/S352) | Boston Scientific Corp | 2014-05-07 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S034) | Integra Lifesciences Corp. | 2014-05-07 |
| ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM (P910073/S125) | Boston Scientific | 2014-05-07 |
| EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S036) | Bioventus, LLC | 2014-05-07 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S052) | Integra LifeSciences Corporation | 2014-05-07 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S017) | Ventana Medical Systems, Inc. | 2014-05-06 |
| PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S028) | Ventana Medical Systems, Inc. | 2014-05-06 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S034) | Medtronic Vascular | 2014-05-06 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S035) | ABBOTT MEDICAL | 2014-05-06 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S014) | Ventana Medical Systems, Inc. | 2014-05-06 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM (P100040/S019) | Medtronic Vascular | 2014-05-06 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S138) | Boston Scientific Corp | 2014-05-05 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S034) | Coloplast Corp. | 2014-05-05 |
| XELOS DR-T ICD'S (P000009/S057) | Biotronik, Inc. | 2014-05-04 |
| ENTOVIS PROMRI PACEMAKER SYSTEM (P950037/S132) | Biotronik, Inc. | 2014-05-04 |
| ILESTO ICD'S AND CRT-D'S (P050023/S074) | Biotronik, Inc. | 2014-05-04 |
| EVIA CRT-P'S (P070008/S050) | Biotronik, Inc. | 2014-05-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S480) | Medtronic Cardiac Rhythm Disease Management | 2014-05-02 |
| BAUSCH & LOMB SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES (N16895/S094) | Bausch & Lomb, Inc. | 2014-05-02 |
| AID-B/BR AND VENTAK ICD (P830060/S077) | Boston Scientific | 2014-05-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S093) | W. L. Gore & Associates, Inc. | 2014-05-02 |
| BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES (P960022/S009) | Bausch & Lomb, Inc. | 2014-05-02 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S194) | Boston Scientific Corp | 2014-05-02 |
| BRAVACRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S441) | Medtronic Cardiac Rhythm Disease Management | 2014-05-02 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S039) | Medtronic Vascular | 2014-05-02 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S006) | Highridge Medical, LLC | 2014-05-02 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S006) | Highridge Medical, LLC | 2014-05-02 |
| CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS (P030005/S106) | Guidant Corp. | 2014-05-02 |
| MYCARELINK PATIENT MONITOR (P890003/S308) | Medtronic, Inc. | 2014-05-02 |
| PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER (N970003/S159) | Boston Scientific Corp | 2014-05-02 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S077) | Medtronic, Ireland | 2014-05-02 |
| DEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S017) | Dexcom, Inc. | 2014-05-02 |
| VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS (P010012/S347) | Boston Scientific Corp | 2014-05-02 |
| VENTAK PRX, VENTAK MINI FAMILIES OF ICDS (P910077/S141) | Boston Scientific | 2014-05-02 |
| VIGOR, MERIDIAN, DISCOVER FAMILIES OF PACEMAKER (P940031/S076) | Boston Scientific | 2014-05-02 |
| VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF ICDS (P960040/S310) | Boston Scientific | 2014-05-02 |
| ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS (P910073/S124) | Boston Scientific | 2014-05-02 |
| PRECISSION SPINAL CORD SIMULATOR (SCS) SYSTEM (P030017/S195) | Boston Scientific Corp | 2014-05-02 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PALTINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIR (P110010/S080) | Boston Scientific Corp | 2014-05-01 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S059) | Boston Scientific Corp | 2014-05-01 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S137) | Boston Scientific Corp | 2014-05-01 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S095) | Boston Scientific Corp | 2014-05-01 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S127) | Boston Scientific Scimed, Inc. | 2014-05-01 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S069) | Boston Scientific Corp | 2014-05-01 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S002) | Medinol, Ltd. | 2014-05-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S079) | Boston Scientific Corp | 2014-05-01 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S027) | Beckman Coulter, Inc. | 2014-05-01 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S121) | Boston Scientific Scimed, Inc. | 2014-05-01 |
| NEUROPACE RNS SYSTEM (P100026/S016) | NeuroPace, Inc. | 2014-05-01 |
| MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES (P040044/S053) | Cordis US Corporation | 2014-05-01 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S026) | Beckman Coulter, Inc. | 2014-05-01 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S039) | Edwards Lifesciences, LLC | 2014-05-01 |
| PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S (P960040/S313) | Boston Scientific | 2014-05-01 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S094) | Boston Scientific Corp | 2014-05-01 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S049) | Boston Scientific Corp | 2014-05-01 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S010) | Beckman Coulter, Inc. | 2014-05-01 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S057) | Boston Scientific | 2014-05-01 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S037) | Beckman Coulter, Inc. | 2014-05-01 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S052) | Edwards Lifesciences, LLC | 2014-05-01 |
| PUNCTUA, COGNIS, ENERGY, & INCEPTA CRT-D'S (P010012/S350) | Boston Scientific Corp | 2014-05-01 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S123) | Edwards Lifesciences, LLC | 2014-05-01 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S001) | Cardiva Medical, Inc. | 2014-04-30 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S052) | Cordis US Corporation | 2014-04-30 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008) | Inspire Medical Systems | 2014-04-30 |
| REVEAL LINQ SOFTWARE MODEL SWO26 (P890003/S304) | Medtronic, Inc. | 2014-04-30 |
| REPEL-CV BIORESORBABLE ADHESION BARRIER (P070005/S003) | Pathfinder Cell Therapy, Inc. | 2014-04-30 |
| NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS) (P840001/S267) | Medtronic Neuromodulation | 2014-04-30 |
| VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM (P100040/S017) | Medtronic Vascular | 2014-04-30 |
| NEUROSTIMULATION SYSTEM FOR DEEP BRAIN STIMULATION (DBS) (P960009/S193) | Medtronic, Inc. | 2014-04-30 |
| BIOMET EBI BONE HEALING (P790002/S031) | Ahp Eos Buyer, Inc. | 2014-04-30 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S018) | Anika Therapeutics, Inc. | 2014-04-30 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S001) | Abbott Vascular (Idef Technologies Inc) | 2014-04-30 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL (P860057/S122) | Edwards Lifesciences, LLC | 2014-04-30 |
| PROVISC (P890047/S043) | Alcon Research, Ltd. | 2014-04-29 |
| MARGINPROBE SYSTEM (P110014/S001) | Dilon Medical Technologies, Ltd. | 2014-04-29 |
| CERVISTA HPV HR AND GENFIND KIT (P080014/S018) | Hologic, Inc. | 2014-04-29 |
| APTIMA HPV ASSAY (P100042/S002) | Gen-Probe Incorporated | 2014-04-29 |
| APTIMA HPV 16 18/45 GENETYPE ASSAY (P120007/S002) | Gen-Probe Incorporated | 2014-04-29 |
| INVIVE AND INTUA CRT PS (P030005/S108) | Guidant Corp. | 2014-04-29 |