| Enroute Transcarotid Stent System (P140026/S006) | Boston Scientific Corporation | 2017-04-13 |
| WATCHMAN Left Atrial Appendage Closure Technology (P130013/S013) | Boston Scientific Corp | 2017-04-13 |
| IsoMed Implantable Infusion System (P990034/S036) | Medtronic, Inc. | 2017-04-13 |
| Medtronic CoreValve Evolut R Transcather Aortic Valve(bioprosthesis); EnVeo R Delivery Catheter System; EnVeo R Loading (P130021/S036) | Medtronic, Inc. | 2017-04-13 |
| Medtronic Cardiac Rhythm and Heart Failure (P010031/S587) | Medtronic Cardiac Rhythm Disease Management | 2017-04-12 |
| Amplia MRI CRT-D, Claria MRI CRT-D, Compia MRI CRT-D (P010031/S584) | Medtronic Cardiac Rhythm Disease Management | 2017-04-12 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S627) | Medtronic Cardiac Rhythm Disease Management | 2017-04-12 |
| HER2 CISH pharmDX Kit (P100024/S012) | Dako Denmark A/S | 2017-04-12 |
| Urovysion Bladder Cancer Kit (P030052/S020) | Abbott Molecular | 2017-04-12 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S013) | Abbott Molecular, Inc. | 2017-04-12 |
| Medtronic Vascular Endurant Stent Graft System (P100021/S062) | Medtronic Vascular | 2017-04-12 |
| Restylane Refyne, Restylane Defyne (P140029/S001) | Q-Med AB | 2017-04-12 |
| HER2 IQFISH pharmDx (P040005/S014) | Agilent Technologies Singapore (International) Pte , Ltd. | 2017-04-12 |
| CyPass Micro-Stent (P150037/S004) | Alcon Research, Ltd. | 2017-04-12 |
| Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire. (P150003/S028) | Boston Scientific Corporation | 2017-04-11 |
| Allegro Topolyzer Vario (P020050/S026) | Alcon Laboratories, Inc. | 2017-04-11 |
| Allegro Topolyzer Vario (P030008/S022) | Alcon Laboratories, Inc. | 2017-04-11 |
| MEDTRONIC COREVALVE(TM) EVOLUT(TM) R SYSTEM (P130021/S028) | Medtronic, Inc. | 2017-04-11 |
| HeartMate II LVAS (P060040/S066) | ABBOTT MEDICAL | 2017-04-11 |
| Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, Relia IPG (P980035/S492) | Medtronic, Inc. | 2017-04-11 |
| Consulta, Syncra, Viva CRT-P (P010015/S323) | Medtronic, Inc. | 2017-04-11 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S024) | Cook Ireland, Ltd. | 2017-04-11 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S139) | Boston Scientific Corp | 2017-04-11 |
| ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS) (P150012/S021) | Boston Scientific | 2017-04-11 |
| VASCADE 6/7f VCS & VASCADE 5F VCS (P120016/S023) | Cardiva Medical, Inc. | 2017-04-11 |
| FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS) (P960004/S078) | Boston Scientific | 2017-04-11 |
| Mentor Saline-Filled and Spectrum Breast Implants (P990075/S039) | Mentor Worldwide, LLC | 2017-04-10 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S039) | Mentor Corp. | 2017-04-10 |
| Biofinity XR Toric (P080011/S057) | CooperVision, Inc. | 2017-04-10 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S039) | ABBOTT MEDICAL | 2017-04-10 |
| Mentor Memory Shape Breast Implants (P060028/S021) | Mentor Worldwide, LLC | 2017-04-10 |
| DEFLUX INJECTABLE GEL (P000029/S081) | Palette Life Sciences | 2017-04-07 |
| IntellaNav Open Irrigated Ablation Catheter (P150005/S018) | Boston Scientific Corp | 2017-04-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S036) | Edwards Lifesciences, LLC | 2017-04-07 |
| Rx Acculink Carotid Stent System (P040012/S059) | Abbott Vascular | 2017-04-07 |
| AMS 700 Penile Prosthesis (N970012/S129) | Boston Scientific Corp | 2017-04-07 |
| SOLESTA INJECTABLE GEL (P100014/S018) | Palette Life Sciences | 2017-04-07 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S076) | Boston Scientific Corp | 2017-04-07 |
| INNOVA(TM)VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S021) | Boston Scientific Corporation | 2017-04-07 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S071) | Edwards Lifesciences, LLC | 2017-04-07 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S018) | Abbott Vascular, Inc. | 2017-04-07 |
| Carpentier-Edwards PERIMOUNT pericardial Bioprostheses (P860057/S158) | Edwards Lifesciences, LLC | 2017-04-07 |
| Rx Herculink Elite Renal and Biliary Stent System (P110001/S013) | Abbott Vascular | 2017-04-07 |
| EDWARDS INTUITY Elite Valve System (P150036/S006) | Edwards Lifesciences, LLC | 2017-04-07 |
| HeartWare Left Ventricular Assist System (P100047/S082) | Medtronic | 2017-04-06 |
| Zilver Vascular Stent (P050017/S015) | Cook Ireland, Ltd. | 2017-04-06 |
| AMS 700 Inflatable Penile Prosthesis (with and without Inhibizone Treatment) (N970012/S132) | Boston Scientific Corp | 2017-04-06 |
| Bellafill Dermal Filter (P020012/S013) | Tiger Aesthetics Medical, LLC | 2017-04-06 |
| AMS 800 Urinary Control System Product Line (P000053/S078) | Boston Scientific Corp | 2017-04-06 |
| COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013/S034) | Starr Surgical Co. | 2017-04-06 |
| Juvederm 24 HV, Juvederm 30 and Juvederm 30HV Gel Implants (P050047/S057) | Allergan | 2017-04-06 |
| Juvederm Voluma XC (P110033/S027) | Allergan | 2017-04-06 |
| XIENCE V XIENCE nano Everolimus Eluting Coronary Stent System; XIENCE PRIMME /Xpedition Everolimus Eluting Coronary Sten (P110019/S090) | Abbott Vascular | 2017-04-06 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S023) | Cook Ireland, Ltd. | 2017-04-06 |
| NeuroPace RNS System (P100026/S048) | NeuroPace, Inc. | 2017-04-05 |
| Raindrop Near Vision Inlay (P150034/S003) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2017-04-05 |
| EnVeo R Delivery Catheter System (P130021/S035) | Medtronic, Inc. | 2017-04-05 |
| iDesign Advanced WaveScan Studio (P930016/S050) | Amo Manufacturing USA, LLC | 2017-04-05 |
| SNS Urinary Neurostimulator Implantable InterStim (P970004/S238) | Medtronic Neuromodulation | 2017-04-04 |
| En Veo R DCS and En Veo R LS (P130021/S032) | Medtronic, Inc. | 2017-04-04 |
| Mentor MemoryShape Breast Implants (P060028/S020) | Mentor Worldwide, LLC | 2017-04-04 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S052) | Syncardia Systems, LLC | 2017-04-04 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S038) | Mentor Corp. | 2017-04-04 |
| Mentor Saline-Filled and SPECTRUM Breast Implants (P990075/S038) | Mentor Worldwide, LLC | 2017-04-04 |
| Master Itrel Spinal Cord Stimulation System (P840001/S354) | Medtronic Neuromodulation | 2017-04-04 |
| SNS Bowel Neurostimulators Implantable InterStim (P080025/S133) | Medtronic Neuromodulation | 2017-04-04 |
| Activa Deep Brain Stimulation Therapy System (P960009/S272) | Medtronic, Inc. | 2017-04-04 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S033) | Edwards Lifesciences, LLC | 2017-04-03 |
| PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS (P090029/S007) | Medtronic Sofamor Danek USA, Inc. | 2017-04-03 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021) | Exactech, Inc. | 2017-04-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S068) | Edwards Lifesciences, LLC | 2017-04-03 |
| Trifecta Valve with Glide (P100029/S025) | ABBOTT MEDICAL | 2017-04-03 |
| HER2 CISH pharmDx Kit (P100024/S013) | Dako Denmark A/S | 2017-04-03 |
| SynchroMed II Motor Gear Train Shafts (P860004/S261) | Medtronic, Inc. | 2017-04-03 |
| CLARISERT PRELOADED IOL SYSTEM (P080004/S016) | Hoya Surgical Optics, Inc. | 2017-03-31 |
| Syncardia Temporary Cardio West Total Artificial Heart (TAH-T) (P030011/S049) | Syncardia Systems, LLC | 2017-03-31 |
| Algovita Spinal Cord Stimulation System (P130028/S015) | Nuvectra Corporation | 2017-03-31 |
| PROMETRA PATIENT THERAPY CONTROLLER (P080012/S036) | Infusyn Therapeutics, LLC | 2017-03-31 |
| Activa Deep Brain Stimulation Therapy System (P960009/S273) | Medtronic, Inc. | 2017-03-31 |
| Ophthaalmic Viscoelastic (P000046/S026) | Anika Therapeutics, Inc. | 2017-03-31 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S030) | Medtronic, Inc. | 2017-03-30 |
| Revo MRI SureScan IPG (P090013/S251) | Medtronic, Inc. | 2017-03-30 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet (P030054/S325) | ABBOTT MEDICAL | 2017-03-30 |
| Amplia MRI CRT-D,MRI Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D; Concerto II CRT (P010031/S586) | Medtronic Cardiac Rhythm Disease Management | 2017-03-30 |
| Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP (P030035/S155) | ABBOTT MEDICAL | 2017-03-30 |
| Current+, Fortify, Fortify Assura, Ellipse, Promote+ (P910023/S383) | ABBOTT MEDICAL | 2017-03-30 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S004) | ABBOTT MEDICAL | 2017-03-30 |
| IsoFlex Optim (P960030/S054) | ABBOTT MEDICAL | 2017-03-30 |
| Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec (P980016/S626) | Medtronic Cardiac Rhythm Disease Management | 2017-03-30 |
| Durata, Durata, Optisure (P950022/S104) | ABBOTT MEDICAL | 2017-03-30 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx (P880086/S281) | ABBOTT MEDICAL | 2017-03-30 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S322) | Medtronic, Inc. | 2017-03-30 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 (P100025/S012) | Meridian Bioscience, Inc. | 2017-03-30 |
| Prometra Programmable Infusion Pump System (P080012/S039) | Infusyn Therapeutics, LLC | 2017-03-30 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG (P980035/S491) | Medtronic, Inc. | 2017-03-30 |
| Algovita Spinal Cord Stimulation System (P130028/S016) | Nuvectra Corporation | 2017-03-30 |
| Tendril SDX Lead, Tendril ST Lead, OptiSence, Tendril STS Lead (P960013/S092) | ABBOTT MEDICAL | 2017-03-30 |
| BELOTERO BALANCE (P090016/S019) | Merz North America, Inc. | 2017-03-29 |
| Surgicel Brand Absorbable Hemostat (N12159/S043) | ETHICON, Inc. | 2017-03-29 |
| Nucleus Hybrid L24 Implant System (P130016/S023) | Cochlear Americas | 2017-03-29 |