| MOSAIC PORCINE BIOPROSTHESIS (P990064/S060) | Medtronic, Inc. | 2014-12-02 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S029) | Medtronic, Inc. | 2014-12-02 |
| IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT (P930027/S016) | Siemens Healthcare Diagnostics, Inc. | 2014-12-02 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S051) | Medtronic, Inc. | 2014-12-02 |
| MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT (P990075/S029) | Mentor Worldwide, LLC | 2014-11-26 |
| ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S011) | Roche Diagnostics Corp. | 2014-11-26 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S165) | Medtronic Minimed | 2014-11-26 |
| MYSENTRY SYSTEM ; MYSENTRY MONITOR (P980022/S169) | Medtronic Minimed | 2014-11-26 |
| ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S013) | Roche Diagnostics Corp. | 2014-11-26 |
| ELECSYS HBEAG ON MODULAR ANALYTICS E170 (P130015/S002) | Roche Diagnostics Operations, Inc. | 2014-11-26 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S208) | Boston Scientific Corp | 2014-11-26 |
| ELECSYS ANTI-HBC ON COBAS E 601 (P100031/S012) | Roche Diagnostics Corp. | 2014-11-26 |
| MINIMED 530G INSULIN PUMP (P120010/S039) | Medtronic, Inc. | 2014-11-26 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S029) | Dexcom, Inc. | 2014-11-26 |
| MELAFIND (P090012/S007) | Strata Skin Sciences, Inc. | 2014-11-26 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S058) | Cordis US Corporation | 2014-11-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S061) | Edwards Lifesciences, LLC | 2014-11-25 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S042) | Boston Scientific Corporation | 2014-11-25 |
| GENESYS HTA SYSTEM (P000040/S034) | Axora Medical, Inc. | 2014-11-25 |
| ENDURANT IIS STENT GRAFT SYSTEM (P100021/S042) | Medtronic Vascular | 2014-11-25 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S018) | Edwards Lifesciences, LLC | 2014-11-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S048) | Edwards Lifesciences, LLC | 2014-11-25 |
| ANIMAS VIBE SYSTEM (P130007) | Animas Corp. | 2014-11-25 |
| MITROFLOW AORTIC PERICARDIAL HEART CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT (P060038/S021) | Corcym Canada Corp | 2014-11-25 |
| INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM (P110006/S004) | GE Healthcare | 2014-11-24 |
| ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T (P070008/S058) | Biotronik, Inc. | 2014-11-21 |
| EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI; (P950037/S144) | Biotronik, Inc. | 2014-11-21 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE +, QUADRA ASSURA, UNIFY, UNIFY ASSURA AND UNIFY QUADRA FAMILY (P030054/S277) | ABBOTT MEDICAL | 2014-11-21 |
| ACCENT, ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKERS (P880086/S250) | ABBOTT MEDICAL | 2014-11-21 |
| SOF SENSOR (P980022/S162) | Medtronic Minimed | 2014-11-21 |
| ANTHEM, ALLURE AND ALLURE QUADRA FAMILY OF CRT-P (P030035/S128) | ABBOTT MEDICAL | 2014-11-21 |
| EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE (P890023/S022) | The Cooper Companies | 2014-11-21 |
| ENLITE SENSOR (P120010/S038) | Medtronic, Inc. | 2014-11-21 |
| RESTYLANE / RESTYLANE-L, PERLANE, PERLANE-L(INJECTABLE GELS), RESTYLANE SILK (P040024/S078) | Q-Med AB | 2014-11-21 |
| IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4) (P050023/S082) | Biotronik, Inc. | 2014-11-21 |
| CURRENT, CURRENT ACCEL, CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES (P910023/S347) | ABBOTT MEDICAL | 2014-11-21 |
| NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S013) | Nidek Co., Ltd. | 2014-11-21 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S210) | Medtronic, Inc. | 2014-11-21 |
| TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZBM00, SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P (P980040/S052) | Johnson & Johnson Surgical Vision, Inc. | 2014-11-21 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN, ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S076) | W. L. Gore & Associates, Inc. | 2014-11-21 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S015) | W. L. Gore & Associates, Inc. | 2014-11-21 |
| ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P120012/S005) | Abbott Molecular | 2014-11-20 |
| ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM (P100017/S010) | Abbott Molecular, Inc. | 2014-11-20 |
| FORTIFY, FORTIFY ASSURA FAMILY OF ICDS (P910023/S343) | ABBOTT MEDICAL | 2014-11-20 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILY OF CRT-DS (P030054/S274) | ABBOTT MEDICAL | 2014-11-20 |
| ABBOTT REALTIME HBV ASSAY (P080026/S012) | Abbott Molecular, Inc. | 2014-11-20 |
| THINPREP PROCESSORS (P950039/S031) | Hologic, Inc. | 2014-11-20 |
| TRI VASCULAR, INC. OVATION /OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006/S016) | Endologix, LLC | 2014-11-20 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S063) | Biosense Webster, Inc. | 2014-11-19 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S163) | Medtronic Minimed | 2014-11-19 |
| MINIMED 530G INSULIN PUMP (P120010/S037) | Medtronic, Inc. | 2014-11-19 |
| MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES (P990075/S028) | Mentor Worldwide, LLC | 2014-11-19 |
| JEVEDERM HYALURONATE GEL IMPLANTS (P050047/S042) | Allergan | 2014-11-19 |
| COOLFLOW IRRIGATION PUMP (P990071/S029) | Biosense Webster, Inc. | 2014-11-19 |
| JUVEDERM VOLUMA XC (P110033/S012) | Allergan | 2014-11-19 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S057) | Zoll Manufacturing Corporation | 2014-11-19 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S042) | Medtronic Vascular | 2014-11-19 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S047) | Biosense Webster, Inc. | 2014-11-19 |
| NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, THERMOCOOL ST (P040036/S046) | Biosense Webster, Inc. | 2014-11-18 |
| AMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S028) | Boston Scientific Corp | 2014-11-18 |
| IMMULITE HBSAG, IMMULITE 2000 HBSAG (P010050/S016) | Siemens Healthcare Diagnostics Products, Ltd. | 2014-11-18 |
| COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S057) | Integra LifeSciences Corporation | 2014-11-18 |
| NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL (P030031/S062) | Biosense Webster, Inc. | 2014-11-18 |
| NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS (P010068/S043) | Biosense Webster, Inc. | 2014-11-18 |
| NAVISTAR 4MM, NAVISTAR RMT 4MM, EZ STEER 4MM NAV (P990025/S042) | Biosense Webster, Inc. | 2014-11-18 |
| CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS (P950005/S054) | Biosense Webster, Inc. | 2014-11-18 |
| AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S052) | Boston Scientific Corp | 2014-11-18 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S101) | Boston Scientific Corp | 2014-11-18 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S007) | Cardiva Medical, Inc. | 2014-11-17 |
| FALOPE-RING BAND AND APPLICATOR SYSTEMS (P870076/S014) | Gyrus Acmi, Inc. | 2014-11-17 |
| LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D (P050023/S077) | Biotronik, Inc. | 2014-11-17 |
| ETRINSA 8/6 DR-T/SR-T, ETRINSA 6 DR/SR, EPYRA 8/6 DR-T/SR-T, ELUNA 8 DR-T/SR-T DR/SR PRO MRI PACEMAKERS (P950037/S137) | Biotronik, Inc. | 2014-11-17 |
| ADVANTIO, INGENIO, VITALIO, FORMIO PACEMAKERS (N970003/S168) | Boston Scientific Corp | 2014-11-17 |
| ETRINSA 8 HF-T, EPYRA 8 HF-T, ELUNA 8 HF-T CRT-P'S (P070008/S053) | Biotronik, Inc. | 2014-11-17 |
| BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S058) | Biotronik, Inc. | 2014-11-17 |
| INVIVE CRT-PS, INTUA CRT-PS (P030005/S114) | Guidant Corp. | 2014-11-17 |
| SYNCHROMED INFUSION SYSTEM (P860004/S216) | Medtronic, Inc. | 2014-11-17 |
| SENSAR 1-PIECE LENS MODEL AAB00 (P980040/S053) | Johnson & Johnson Surgical Vision, Inc. | 2014-11-15 |
| EVERA S DR & SR,, EVERA XT DR & VR , MAXIMO II, PROTECTA , PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S (P980016/S502) | Medtronic Cardiac Rhythm Disease Management | 2014-11-14 |
| Puregraft Serene Breast Implant (P120011) | Bimini Health Tech | 2014-11-14 |
| , BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S (P010031/S466) | Medtronic Cardiac Rhythm Disease Management | 2014-11-14 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S207) | Boston Scientific Corp | 2014-11-14 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S015) | Edwards Lifesciences, LLC | 2014-11-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS; RSR, THEON RSR WITH (P860057/S129) | Edwards Lifesciences, LLC | 2014-11-14 |
| NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S014) | Nidek Co., Ltd. | 2014-11-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S060) | Edwards Lifesciences, LLC | 2014-11-14 |
| RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS (P040024/S070) | Q-Med AB | 2014-11-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S047) | Edwards Lifesciences, LLC | 2014-11-14 |
| EON MINI, PROTEGE AND PROTEGE MRI IPGS (3788. 3789, & 3771) (P010032/S086) | ABBOTT MEDICAL | 2014-11-13 |
| MEDTRONIC OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S039) | Medtronic Ats Medical, Inc. | 2014-11-13 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S049) | Biomet Manufacturing Corp | 2014-11-13 |
| NOVOTFF-100A SYSTEM (P100034/S007) | Novocure, GmbH | 2014-11-12 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT-(MODEL 150) (P790007/S044) | Medtronic Heart Valves | 2014-11-12 |
| HANCOCK LOW POROSITY VALVED CONDUIT (MODEL 105) (P870078/S028) | Medtronic, Inc. | 2014-11-12 |
| HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510) (P980043/S050) | Medtronic, Inc. | 2014-11-12 |
| COAPTITE INJECTABLE IMPLANT (P040047/S037) | Merz North America, Inc. | 2014-11-12 |
| TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA (P980040/S051) | Johnson & Johnson Surgical Vision, Inc. | 2014-11-12 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S005) | Cochlear Americas | 2014-11-12 |
| MOSAIC PORCINE BIOPROSTHESIS- (MODELS 305. 310) (P990064/S059) | Medtronic, Inc. | 2014-11-12 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S061) | Hologic, Inc. | 2014-11-12 |