| Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF (P980023/S080) | Biotronik, Inc. | 2017-03-29 |
| Angio Seal Vascular Closure Device (P930038/S084) | Terumo Medical Corporation | 2017-03-29 |
| Supartz FX and Visco-3 (P980044/S038) | Seikagaku Corp. | 2017-03-29 |
| AMS 800 Urinary Control System (P000053/S077) | Boston Scientific Corp | 2017-03-29 |
| ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331 (P150012/S026) | Boston Scientific | 2017-03-29 |
| VALITUDE Models: U125, U128; VISIONIST Models: U225, U226, U228 (P030005/S151) | Guidant Corp. | 2017-03-29 |
| Nucleus 24 Cochlear Implant System (P970051/S158) | Cochlear Americas | 2017-03-29 |
| ESSENTIO Models: L100, L101, L121; PROPONENT Models: L200, L201, L221; ACCOLADE Models: L300, L301, L321; ALTRUA 2 Model (N970003/S203) | Boston Scientific Corp | 2017-03-29 |
| Gynecare Interceed Absorbable Adhesion Barrier (P880047/S026) | ETHICON, Inc. | 2017-03-29 |
| Synvisc (P940015/S039) | Sanofi Genzyme Corp. | 2017-03-29 |
| COMBI 40+ Cochlear Implant System (P000025/S093) | Med-El Corp. | 2017-03-29 |
| Micra Transcatheter Pacing System (P150033/S019) | Medtronic, Inc. | 2017-03-28 |
| Axsym Total PSA & Architect Total PSA (P910007/S050) | Abbott Laboratories | 2017-03-28 |
| Precision Spinal Cord Stimulator (SCS)System (P030017/S286) | Boston Scientific Corp | 2017-03-28 |
| CERAMAX® Ceramic Total Hip System (P070026/S047) | DePuy Orthopaedics, Inc. | 2017-03-28 |
| STRAUMANN EMDOGAIN(R) (P930021/S016) | The Straumann Company | 2017-03-28 |
| BRACAnalysis CDx (P140020/S009) | Myriad Genetic Laboratories | 2017-03-27 |
| EUCLID SYSTEMS ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S004) | Euclid Vision Corporation | 2017-03-27 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S044) | Ahp Eos Buyer, Inc. | 2017-03-27 |
| MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S009) | Medtronic Minimed | 2017-03-27 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S055) | Ahp Eos Buyer, Inc. | 2017-03-27 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S006) | Medtronic Minimed | 2017-03-27 |
| MINIMED 530G SYSTEM (P120010/S100) | Medtronic, Inc. | 2017-03-27 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S027) | Medtronic Minimed | 2017-03-27 |
| HER2 CISH PHARMDX KIT (P100024/S011) | Dako Denmark A/S | 2017-03-24 |
| Pro-Kinetic Energy Coronary Stent System (P160003/S001) | Biotronik AG | 2017-03-24 |
| Freestyle Bioprosthesis, Models 995, 995CS and 995MS (P970031/S056) | Medtronic, Inc. | 2017-03-24 |
| TECNIS Toric 1-Piece IOL Model ZCT (P980040/S079) | Johnson & Johnson Surgical Vision, Inc. | 2017-03-24 |
| Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz (P010031/S563) | Medtronic Cardiac Rhythm Disease Management | 2017-03-24 |
| PD-L1 IHC NIVOLUMAB PHARMDX (P150025/S004) | Agilent Technologies, Inc. | 2017-03-24 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S097) | Boston Scientific | 2017-03-24 |
| Chilli II Cooled Ablation Catheter andCable (P980003/S072) | Boston Scientific Corp | 2017-03-24 |
| Superion® Indirect Decompression System (IDS) (P140004/S005) | Boston Scientific Neuromodulation | 2017-03-24 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S004) | Agilent Technologies, Inc. | 2017-03-24 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S003) | Biotronik AG | 2017-03-24 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S096) | Boston Scientific Corp | 2017-03-24 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S037) | Boston Scientific Corp | 2017-03-24 |
| PowerLook® Tomo Detection Software (P160009) | Icad, Inc. | 2017-03-24 |
| PD-L1 IHC NIVOLUMAB PHARMDX (P150027/S004) | Dako North America, Inc. | 2017-03-24 |
| PROMUS Element Plus Everolimus-Eluting Stent System/Promus PREMIER Everolimus-Eluting Platinum Chronium Coronary Stent S (P110010/S138) | Boston Scientific Corp | 2017-03-24 |
| Hancock II Bioprosthesis, Models T505 and T510 (P980043/S058) | Medtronic, Inc. | 2017-03-24 |
| Precision Montage and Precision Montage MRI (P030017/S284) | Boston Scientific Corp | 2017-03-24 |
| PSW 1601.U Pacemaker/ICD/CRT non implanted components (P050023/S104) | Biotronik, Inc. | 2017-03-24 |
| DAKO HERCEPTEST (P980018/S023) | Agilent Technologies Singapore (International) Pte , Ltd. | 2017-03-24 |
| Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/ (P070008/S076) | Biotronik, Inc. | 2017-03-24 |
| Mosaic Bioprosthesis, Models 305 and 310 (P990064/S067) | Medtronic, Inc. | 2017-03-24 |
| SIR-Spheres microspheres (P990065/S009) | Sirtex Medical, Inc. | 2017-03-24 |
| Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos (P950037/S167) | Biotronik, Inc. | 2017-03-24 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S016) | Boston Scientific Corp | 2017-03-24 |
| ADAPTA, VERSA, SENSIA IPD; RELIA IPG. (P980035/S475) | Medtronic, Inc. | 2017-03-24 |
| Express SD Monorail Premounted Stent System (P060006/S080) | Boston Scientific Corp | 2017-03-24 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S158) | Boston Scientific Corp | 2017-03-24 |
| PSW 1601.U Pacemaker/ICD/CRT non implanted components (P000009/S069) | Biotronik, Inc. | 2017-03-24 |
| Precision Montage MRI Spinal Cord Stimulator (SCS)System; Precision Montage Spinal Cord Stimulator (SCS)System; Precisio (P030017/S285) | Boston Scientific Corp | 2017-03-24 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S038) | Medtimo, Inc. | 2017-03-23 |
| Activa Deep Brain Stimulation Therapy System (P960009/S271) | Medtronic, Inc. | 2017-03-23 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S137) | Boston Scientific Corp | 2017-03-23 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S013) | Bolton Medical, Inc. | 2017-03-23 |
| ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM (P160025) | Biotronik AG | 2017-03-23 |
| Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens (P980040/S078) | Johnson & Johnson Surgical Vision, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| PRECISION, PRECISION SPECTRA, PRECISION NOVI, PRECISION MONTAGE, AND PRECISION MONTAGE MRI SCS SYSTEMS (P030017/S274) | Boston Scientific Corp | 2017-03-23 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S353) | Medtronic Neuromodulation | 2017-03-23 |
| Precision Spinal Cord Stimulation SCS) System (P030017/S282) | Boston Scientific Corp | 2017-03-22 |
| Arctic Front Catheter, Arctic Front Advance Catheter, Arctic Front Advance ST Catheter, Freezor MAX Catheter, Manual ret (P100010/S062) | Medtronic Cryocath, LP | 2017-03-22 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S054) | W. L. Gore & Associates, Inc. | 2017-03-22 |
| Freezor Catheter, Freezor Xtra Catheter, Freezor MAX Surgical Device, Electrical umbilical cable, Coaxial umbilical cabl (P020045/S081) | Medtronic Cryocath, LP | 2017-03-22 |
| Maestro Rechargeable System (P130019/S013) | Reshape Lifesciences, Inc. | 2017-03-22 |
| MULTI-LINK VISION/MULTI-LINK 8 LL/SV CORONARY STENT SYSTEMS (P020047/S064) | Abbott Vascular | 2017-03-21 |
| ALTRUA 2 Models: S701, S702, S722 (N970003/S202) | Boston Scientific Corp | 2017-03-21 |
| Tendril SDX/ST/STS and optisense leads (LV active) (P960013/S091) | ABBOTT MEDICAL | 2017-03-21 |
| Supartz Device Family (P980044/S037) | Seikagaku Corp. | 2017-03-21 |
| IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA (P930027/S017) | Siemens Healthcare Diagnostics, Inc. | 2017-03-21 |
| XIENCE XPEDITION & ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S089) | Abbott Vascular | 2017-03-21 |
| Gel-One (P080020/S025) | Seikagaku Corp. | 2017-03-21 |
| Emblem S-ICD Programmer - Plexus SMT Mfg. Line (P110042/S079) | Boston Scientific Corporation | 2017-03-21 |
| ACRYSOF RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS (P040020/S067) | Alcon Research, Ltd. | 2017-03-21 |
| QuickFlex u and Quarlet Leads (CRT) (P030054/S324) | ABBOTT MEDICAL | 2017-03-21 |
| MULTI-LINK RX ULTRA CORONARY STENT SYSTEMS (P970020/S082) | Abbott Vascular, Inc. | 2017-03-21 |
| IsoFlex Optim leads (LV Passive) (P960030/S053) | ABBOTT MEDICAL | 2017-03-21 |
| Tendril MRI leads (MRI) (P140033/S003) | ABBOTT MEDICAL | 2017-03-21 |
| Durata and Optisure Leads (HV Active and Passive) (P950022/S103) | ABBOTT MEDICAL | 2017-03-21 |
| Precision Spinal Cord Stimulation (SCS) System (P030017/S283) | Boston Scientific Corp | 2017-03-20 |
| Coaxial Umbilical Cable (P020045/S080) | Medtronic Cryocath, LP | 2017-03-20 |
| Platinium CRT-Ds (Cardiac Resynchronization Therapy-Defibrillator) (P060027/S089) | MicroPort CRM USA, Inc. | 2017-03-20 |
| Platinium VR and Platinium DR ICD's (Implantable Cardioverter Defobrillator) (P980049/S124) | MicroPort CRM USA, Inc. | 2017-03-20 |
| Medtronic CoreValve Evolut PRO System (P130021/S029) | Medtronic, Inc. | 2017-03-20 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S017) | Tandem Diabetes Care, Inc. | 2017-03-20 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE (P130005/S014) | Cardiovascular Systems, Inc. | 2017-03-19 |
| KARL STORZ Photodynamic D-Light C (PDD) System (P050027/S008) | KARL STORZ Endoscopy-America, Inc. | 2017-03-17 |
| JUVEDERM VOLLURE XC (P110033/S020) | Allergan | 2017-03-17 |
| Dimension FPSA Flex reagent cartridge (P020027/S025) | Siemens Healthcare Diagnostics | 2017-03-16 |
| WATCHMAN Left Atrial Appendage Closeure Technology (P130013/S012) | Boston Scientific Corp | 2017-03-16 |
| Perceval Sutureless Heart Valve (P150011/S009) | Corcym S.r.l. | 2017-03-16 |
| Dimension TPSA Flex reagent cartridge (P000021/S030) | Siemens Healthcare Diagnostics | 2017-03-16 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S029) | Medtronic, Inc. | 2017-03-16 |
| VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device (P840064/S065) | Alcon Laboratories | 2017-03-15 |
| Express SD Renal Monorail Premounted Stent System (P060006/S079) | Boston Scientific Corp | 2017-03-15 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S036) | Boston Scientific Corp | 2017-03-15 |
| Novocure Ltd.'s Optune (P100034/S017) | Novocure, GmbH | 2017-03-15 |