| CELSIUS FLTR UNI-DIRECTIONAL CATHETER (P950005/S052) | Biosense Webster, Inc. | 2014-09-12 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S003) | Cochlear Americas | 2014-09-12 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S462) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S273) | ABBOTT MEDICAL | 2014-09-12 |
| MAESTRO COCHLEAR IMPLANT SYSTEM (P000025/S080) | Med-El Corp. | 2014-09-12 |
| BRAVA CRT-D, BRAVA QUADA CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S463) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S105) | Boston Scientific Corp | 2014-09-12 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (P040036/S045) | Biosense Webster, Inc. | 2014-09-12 |
| SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S089) | St. Jude Medical, Inc. | 2014-09-12 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S060) | ABBOTT MEDICAL | 2014-09-12 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S498) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| CELSIUS FLTR BI-DIRECTIONAL CATHETER (P010068/S041) | Biosense Webster, Inc. | 2014-09-12 |
| THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S060) | Biosense Webster, Inc. | 2014-09-12 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S499) | Medtronic Cardiac Rhythm Disease Management | 2014-09-12 |
| ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S (P910023/S342) | ABBOTT MEDICAL | 2014-09-12 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S027) | Syncardia Systems, LLC | 2014-09-12 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S002) | Edwards Lifesciences, LLC | 2014-09-12 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S003) | Boston Scientific Corp | 2014-09-12 |
| MEDTRONIC 4195 ATTAIN STARFIX MODEL 4195 LV LEAD (P060039/S062) | Medtronic, Inc. | 2014-09-12 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S047) | Medtronic | 2014-09-12 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S093) | Boston Scientific Corp | 2014-09-11 |
| NIRXCELL COCR CORONARY STENT ON RX (P110004/S005) | Medinol, Ltd. | 2014-09-11 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S004) | Cochlear Americas | 2014-09-11 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S037) | Allergan | 2014-09-11 |
| FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S069) | Boston Scientific Corp | 2014-09-11 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S106) | Boston Scientific Corp | 2014-09-11 |
| JUVEDERM VOLUMA XC (P110033/S007) | Allergan | 2014-09-11 |
| HIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE (P960058/S106) | Advanced Bionics | 2014-09-10 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S390) | Medtronic, Inc. | 2014-09-10 |
| ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) (P010012/S369) | Boston Scientific Corp | 2014-09-10 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S012) | Merz North America, Inc. | 2014-09-10 |
| RF ENHANCR II, RF MARINR 7FR, RF MARINR 5FR, RF MARINR UNIPOLAR, RF CONTACTR, RF CONDUCTR (P930029/S044) | Medtronic, Inc. | 2014-09-10 |
| EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S497) | Medtronic Cardiac Rhythm Disease Management | 2014-09-10 |
| BRAVA & QUAD CRT-DS, VIVA QUAD S & XT CRT-DS, VIVA S & XT CRT-DS (P010031/S461) | Medtronic Cardiac Rhythm Disease Management | 2014-09-10 |
| EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (P910056/S018) | Bausch & Lomb, Inc. | 2014-09-10 |
| ORIGEN, INOGEN, DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S330) | Boston Scientific | 2014-09-10 |
| ESTEEM (P090018/S027) | Envoy Medical Corporation | 2014-09-10 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES (P080011/S031) | CooperVision, Inc. | 2014-09-09 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND (P010013/S059) | Hologic, Inc. | 2014-09-09 |
| TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S014) | Endologix, LLC | 2014-09-09 |
| FREQUENCY (METHAFILCON A AND B) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P850079/S067) | CooperVision, Inc. | 2014-09-09 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S007) | KARL STORZ Endoscopy-America, Inc. | 2014-09-09 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S011) | Merz North America, Inc. | 2014-09-09 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S121) | Cochlear Americas | 2014-09-09 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S006) | Medtronic, Inc. | 2014-09-09 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S007) | Cochlear Americas | 2014-09-09 |
| MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS (P060028/S001) | Mentor Worldwide, LLC | 2014-09-09 |
| CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC UCD, INSYNC II MARQUIS, INSY (P010031/S451) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S027) | Smith & Nephew, Inc. | 2014-09-05 |
| CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P (P010015/S242) | Medtronic, Inc. | 2014-09-05 |
| GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD (P900061/S129) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| JEWEL AF, GEM III AT (P980050/S092) | Medtronic, Inc. | 2014-09-05 |
| ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4, (P980016/S489) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST (P820003/S129) | Medtronic Cardiac Rhythm Disease Management | 2014-09-05 |
| OMNILINK ELITE VASCULAR BALLON-EXPANDABLE STENT SYSTEM (P110043/S007) | Abbott Vascular-Cardiac Therapies | 2014-09-05 |
| LIVEWIRE TC AND SAFIRE ABLATION CATHETERS (P960016/S048) | St Jude Medical | 2014-09-05 |
| REVO MRI, ENRHYTHM MRI (P090013/S147) | Medtronic, Inc. | 2014-09-05 |
| ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, ANALYZER, VITATRON LEGACY, VITATRON (P890003/S311) | Medtronic, Inc. | 2014-09-05 |
| PCD (P920015/S133) | Medtronic, Inc. | 2014-09-05 |
| DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES (P990001/S118) | Medtronic, Inc. | 2014-09-05 |
| VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM (P910077/S146) | Boston Scientific | 2014-09-05 |
| ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST,PREMIER, PREVAIL, VITATRON LEGACY SR (P850051/S081) | Medtronic, Inc. | 2014-09-05 |
| NEUROPACE RNS SYSTEM (P100026/S022) | NeuroPace, Inc. | 2014-09-05 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S047) | Vistakon, Division of Johnson & Johnson Vision Car | 2014-09-05 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA, (P980035/S382) | Medtronic, Inc. | 2014-09-05 |
| PREVELLE SILK (P030032/S017) | Genzyme Biosurgery | 2014-09-05 |
| KAPPA 400 (P970012/S095) | Medtronic, Inc. | 2014-09-05 |
| LEGEND PLUS (P930022/S016) | Medtronic, Inc. | 2014-09-05 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S062) | Abbott Vascular | 2014-09-04 |
| ANTHEM, ANTHEM RF, FRONTIER, FRONTIER II (P030035/S124) | ABBOTT MEDICAL | 2014-09-04 |
| ATTAIN STARFIX LEAD (P060039/S059) | Medtronic, Inc. | 2014-09-04 |
| ANGIOJET FAMILY OF THROMBECTOMY SETS (P980037/S043) | Boston Scientific Corp | 2014-09-04 |
| ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS (P960040/S329) | Boston Scientific | 2014-09-04 |
| XIENCE V, XIENCE NANO,XIENCE PRIME, XIENCE PRIME LONG LESION,XIENCE XPEDITION XIENCE XPEDITION SMALL VESSEL AND XPEDITIO (P070015/S117) | Abbott Vascular, Inc. | 2014-09-04 |
| ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX (P880086/S246) | ABBOTT MEDICAL | 2014-09-04 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S029) | Boston Scientific Corporation | 2014-09-04 |
| BELOTERO BALANCE DERMAL FILLER (P090016/S010) | Merz North America, Inc. | 2014-09-03 |
| XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S070) | Abbott Vascular | 2014-09-03 |
| CAPSURE SENSE LEAD (P830061/S114) | Medtronic Cardiac Rhythm Disease Management | 2014-09-03 |
| NEUROPACE RNS SYSTEM (P100026/S021) | NeuroPace, Inc. | 2014-09-03 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S010) | Medtronic Vascular, Inc. | 2014-09-03 |
| CAPSUREFIX MRI LEAD (P090013/S153) | Medtronic, Inc. | 2014-09-03 |
| CAPSUREFIX NOVUS LEAD (P930039/S116) | Medtronic, Inc. | 2014-09-03 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S062) | Medtronic, Inc. | 2014-09-03 |
| ENDURANT II STENT GRAFT SYSTEM (P100021/S032) | Medtronic Vascular | 2014-09-03 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S017) | OraSure Technologies, Inc. | 2014-09-02 |
| ANGIOJET ULTRA THOMRBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THOMBRBECTOMY SET, VG THOMRBECTOMY SET, DISTAFLEX THOMBRBECTOM (P980037/S042) | Boston Scientific Corp | 2014-09-02 |
| NEUROPACE RNS SYSTEM (P100026/S020) | NeuroPace, Inc. | 2014-09-02 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S004) | Medtronic, Inc. | 2014-09-02 |
| RADIESSE DERMAL FILLERS (P050052/S059) | Merz North America, Inc. | 2014-09-02 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S005) | Abbott Vascular (Idef Technologies Inc) | 2014-09-02 |
| RADIESSE DERMAL FILLERS (P050037/S054) | Merz North America, Inc. | 2014-09-02 |
| CARDIOMEMS HF SYSTEM (P100045/S001) | ABBOTT MEDICAL | 2014-08-29 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S113) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| CAPSUREFIX MRI LEAD (P090013/S152) | Medtronic, Inc. | 2014-08-29 |
| PATIENT CABLE, SURGICAL CABLE (P820003/S130) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| SELECTSECURE LEAD (P030036/S073) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD (P920015/S138) | Medtronic, Inc. | 2014-08-29 |
| ADAPTA, VERSA, SENSIA IPG ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S389) | Medtronic, Inc. | 2014-08-29 |
| ACTIVA IMPLANTABLE NEUROSTIMULATIORS (P960009/S201) | Medtronic, Inc. | 2014-08-29 |