| FLEXTOME CUTTING BALLOON MICROSURGICAL DILITATION DEVICE (P950020/S073) | Boston Scientific Corp | 2016-06-09 |
| CARDIOMESSENGER SMART (P050023/S098) | Biotronik, Inc. | 2016-06-08 |
| ANTHOLOGY FEMORAL STEMS (P030022/S033) | Smith & Nephew, Inc. | 2016-06-08 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S018) | DiaSorin, Inc. | 2016-06-08 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S250) | Boston Scientific Corp | 2016-06-08 |
| EXCLUDER BIFURCATED AAA ENDOPROSTHESIS (P020004/S131) | W. L. Gore & Associates, Inc. | 2016-06-08 |
| ETI-AB-EBK PLUS ASSAY (P990041/S020) | DiaSorin, Inc. | 2016-06-08 |
| SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60 (P950037/S156) | Biotronik, Inc. | 2016-06-08 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S007) | Nuvectra Corporation | 2016-06-08 |
| ETI-AB-AUK PLUS ASSAY (P990042/S017) | DiaSorin, Inc. | 2016-06-08 |
| PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR. (P970003/S199) | LivaNova USA, Inc. | 2016-06-08 |
| ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS (P990038/S021) | DiaSorin, Inc. | 2016-06-08 |
| C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S009) | Rayner Intraocular Lenses , Ltd. | 2016-06-08 |
| ETI-AB-COREK PLUS ASSAY (P990045/S018) | DiaSorin, Inc. | 2016-06-08 |
| DIASORIN ETI-EBK PLUS ASSAY (P990043/S021) | DiaSorin, Inc. | 2016-06-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S092) | W. L. Gore & Associates, Inc. | 2016-06-07 |
| INTERSTIM THERAPY SYSTEM (Urinary) (P970004/S213) | Medtronic Neuromodulation | 2016-06-07 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S031) | W. L. Gore & Associates, Inc. | 2016-06-07 |
| PRESTIGE LP CERVICAL DISC (P090029/S004) | Medtronic Sofamor Danek USA, Inc. | 2016-06-07 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S251) | Boston Scientific Corp | 2016-06-07 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S013) | Cardiovascular Systems, Inc. | 2016-06-07 |
| AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, COMPIA MRI CRT-D,COMPIA MRI QUAD CRT-D (P010031/S551) | Medtronic Cardiac Rhythm Disease Management | 2016-06-07 |
| INTERSTIM THERAPY SYSTEM (Bowel) (P080025/S108) | Medtronic Neuromodulation | 2016-06-07 |
| EVERA MRI ICD, VISTA AF MRI VR ICD, VISIA AF VR ICD (P980016/S590) | Medtronic Cardiac Rhythm Disease Management | 2016-06-07 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S075) | Zoll Manufacturing Corporation | 2016-06-06 |
| TACTICATH QUARTZ SET (P130026/S020) | St Jude Medical | 2016-06-06 |
| RADIESSE, RADIESSE(+) (P050052/S077) | Merz North America, Inc. | 2016-06-03 |
| MINIMED 530G INSULIN PUMP (P120010/S076) | Medtronic, Inc. | 2016-06-03 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S056) | Cook, Inc. | 2016-06-03 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S183) | Medtronic Minimed | 2016-06-03 |
| TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM (P990040/S022) | Cerenovus, Inc. | 2016-06-03 |
| RADIESSE LOW VISCOSITY, RADIESSE (+) (P050052/S079) | Merz North America, Inc. | 2016-06-03 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S170) | Depuy, Inc. | 2016-06-03 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S008) | Reshape Lifesciences, Inc. | 2016-06-03 |
| RADIESSE (P050037/S066) | Merz North America, Inc. | 2016-06-03 |
| RADIESSE, RADIESSE LOW VISCOSITY (P050037/S068) | Merz North America, Inc. | 2016-06-03 |
| RADIESSE INJECTABLE IMPLANT (P050037/S070) | Merz North America, Inc. | 2016-06-02 |
| INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM (P130008/S009) | Inspire Medical Systems | 2016-06-02 |
| RADIESSE & RADIESSE (+) LIDOCAINE DERMAL FILLER (P050052/S082) | Merz North America, Inc. | 2016-06-02 |
| COMPLETE SE VASCULAR STENT SYSTEM - ILLIAC (P090006/S017) | Medtronic Vascular | 2016-06-01 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S045) | Zimmer, Inc. | 2016-06-01 |
| RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE (P040024/S090) | Q-Med AB | 2016-06-01 |
| INSPIRE II UPPER AIRWAY STIMULATION SYSTEM (P130008/S010) | Inspire Medical Systems | 2016-06-01 |
| ANIMAS VIBE SYSTEM (P130007/S015) | Animas Corp. | 2016-06-01 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064/S062) | Medtronic, Inc. | 2016-06-01 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S053) | Medtronic, Inc. | 2016-06-01 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S014) | Boston Scientific Corporation | 2016-06-01 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196,4296,4396 LEAD (P080006/S092) | Medtronic, Inc. | 2016-06-01 |
| COMPLETE SE VASCULAR STENT SYSTEM - SFA AND PPA (P110040/S009) | Medtronic Vascular | 2016-06-01 |
| cobas EGFR MUTATION TEST v2 (P150047) | Roche Molecular Systems, Inc. | 2016-06-01 |
| AMS 700 INFLATABLE PENILE PROSTHESES (IPP) (N970012/S115) | Boston Scientific Corp | 2016-05-31 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S011) | Boston Scientific Corporation | 2016-05-31 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S048) | Medtronic Heart Valves | 2016-05-31 |
| JUVEDERM VOLBELLA XC (P110033/S018) | Allergan | 2016-05-31 |
| MOSAIC PORCINE BIOPROSTHETIC (P990064/S063) | Medtronic, Inc. | 2016-05-31 |
| BARD LIFESTENT VASCULAR STENT SYSTEM (P070014/S037) | Bard Peripheral Vascular, Inc. | 2016-05-31 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers (P150012/S002) | Boston Scientific | 2016-05-31 |
| RADIESSE LOW VISCOSITY INJECTABLE IMPLANT; RADIESSE (+) LIDOCAINE DERMANL FILTER (P050052/S076) | Merz North America, Inc. | 2016-05-31 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S032) | Medtronic, Inc. | 2016-05-31 |
| AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S063) | Boston Scientific Corp | 2016-05-31 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S054) | Medtronic, Inc. | 2016-05-31 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S052) | Medtronic, Inc. | 2016-05-31 |
| ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA (P000037/S045) | On-X Life Technologies, Inc. | 2016-05-31 |
| RADIESSE INJECTABLE IMPLANT (P050037/S065) | Merz North America, Inc. | 2016-05-31 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S092) | Abbott Vascular, Inc. | 2016-05-28 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S327) | Medtronic Neuromodulation | 2016-05-27 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S097) | Biotronik, Inc. | 2016-05-27 |
| Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr (P010032/S117) | ABBOTT MEDICAL | 2016-05-27 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S013) | Boston Scientific Corporation | 2016-05-27 |
| DBS Extensions (P140009/S014) | ABBOTT MEDICAL | 2016-05-27 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S162) | Biotronik, Inc. | 2016-05-27 |
| CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP. (P890055/S062) | Intera Oncology | 2016-05-27 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S010) | Abbott Vascular-Cardiac Therapies | 2016-05-27 |
| DAKO HERCEPTEST (P980018/S021) | Agilent Technologies Singapore (International) Pte , Ltd. | 2016-05-27 |
| PHYLAX AV ICD SYSTEM (P000009/S066) | Biotronik, Inc. | 2016-05-27 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S072) | Biotronik, Inc. | 2016-05-27 |
| ENVISTA HYDROPHOBIC INTRAOCULAR LENS (P910056/S022) | Bausch & Lomb, Inc. | 2016-05-27 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S250) | Medtronic, Inc. | 2016-05-27 |
| Axium Neurostimulator System (P150004/S001) | ABBOTT MEDICAL | 2016-05-26 |
| EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S003) | Euclid Vision Corporation | 2016-05-26 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S033) | Infusyn Therapeutics, LLC | 2016-05-26 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S005) | Nuvectra Corporation | 2016-05-26 |
| JUVEDERM Hyaluronate Gel Implants (P050047/S053) | Allergan | 2016-05-26 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S001) | Medtronic, Inc. | 2016-05-25 |
| ADVANTIO, INGENIO, VITALIO, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S188) | Boston Scientific Corp | 2016-05-25 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S068) | Medtronic Vascular | 2016-05-25 |
| ESSENTIO VALITUDE MRI, PROPONENT VALITUDE MRI, ACCOLADE VALITUDE MRI (P150012/S001) | Boston Scientific | 2016-05-25 |
| CARDIAC RESYNCHRONIZATION THERAPY- PACEMAKER (CRT-P); INVIVE AND INTUA MODELS. INGENIO 2. VALITUDE MODEL U125 ; VALITUD (P030005/S136) | Guidant Corp. | 2016-05-25 |
| NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB (P960040/S372) | Boston Scientific | 2016-05-25 |
| VALITUDE, VALITUDE X4, INVIVE, INTUA (P030005/S135) | Guidant Corp. | 2016-05-25 |
| INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE. IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI (N970003/S189) | Boston Scientific Corp | 2016-05-25 |
| NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT (P010012/S419) | Boston Scientific Corp | 2016-05-25 |
| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S588) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Brava Quad CRT-D DTBC (P010031/S548) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| AMPLIA MRI CRT-D; QUAD CRT-D; BRAVA CRT-D; BRAVA QUAD CRT-D; COMPIA MRI CRT-D; QUAD CRT-D; CONCERTO, CONSULTA, MAXIMO II (P010031/S549) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| EVERA MRI, S DR ,S VR, XT DR , XT VR ICD'S; MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR (P980016/S589) | Medtronic Cardiac Rhythm Disease Management | 2016-05-25 |
| Rotablator Rotational Atherectomy System (ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER) (P900056/S153) | Boston Scientific Corp | 2016-05-25 |
| PACEMAKER MODELS. ESSENTIO , PROPONENT, ACCOLADE MRI'S (P150012/S003) | Boston Scientific | 2016-05-25 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S352) | Medtronic, Inc. | 2016-05-24 |