| SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM (P970004/S235) | Medtronic Neuromodulation | 2017-01-26 |
| ESTEEM (P090018/S033) | Envoy Medical Corporation | 2017-01-26 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S350) | Medtronic Neuromodulation | 2017-01-26 |
| INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX (P900033/S058) | Integra Lifesciences Corp. | 2017-01-26 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S089) | Zoll Manufacturing Corporation | 2017-01-26 |
| SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY (P840001/S349) | Medtronic Neuromodulation | 2017-01-26 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S004) | Boston Scientific Corporation | 2017-01-26 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM (BOWEL) (P080025/S131) | Medtronic Neuromodulation | 2017-01-26 |
| DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S268) | Medtronic, Inc. | 2017-01-26 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S269) | Medtronic, Inc. | 2017-01-26 |
| SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM (P080025/S130) | Medtronic Neuromodulation | 2017-01-26 |
| VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA (P030016/S030) | STAAR Surgical Company | 2017-01-25 |
| IMPELLA (P140003/S015) | Abiomed, Inc. | 2017-01-25 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004/S012) | Ev3 Neurovascular | 2017-01-25 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S024) | Medtronic Minimed | 2017-01-25 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S266) | Boston Scientific Corp | 2017-01-25 |
| ACUITY Spiral Heart Failure Leads (P010012/S438) | Boston Scientific Corp | 2017-01-20 |
| GEL-ONE (P080020/S024) | Seikagaku Corp. | 2017-01-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S157) | Edwards Lifesciences, LLC | 2017-01-19 |
| PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS) (P970054/S012) | Diasorin | 2017-01-19 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S155) | Cochlear Americas | 2017-01-19 |
| SUPARTZ FX & VISCO-3 (P980044/S036) | Seikagaku Corp. | 2017-01-19 |
| Tunneling Tool 6996T (P920015/S193) | Medtronic, Inc. | 2017-01-19 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S058) | Dexcom, Inc. | 2017-01-19 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S088) | Zoll Manufacturing Corporation | 2017-01-19 |
| EDWARDS INTUITY ELITE VALVE SYSTEM (P150036/S003) | Edwards Lifesciences, LLC | 2017-01-19 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S074) | Boston Scientific Corporation | 2017-01-19 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUS) (P970055/S014) | Diasorin | 2017-01-19 |
| CollaPlug®, Absorbable Collagen Wound Dressing for Dental Surgery (P840062/S059) | Integra Lifesciences Corp. | 2017-01-19 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S029) | Edwards Lifesciences, LLC | 2017-01-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S069) | Edwards Lifesciences, LLC | 2017-01-19 |
| INGEVITY LEADS (P150012/S025) | Boston Scientific | 2017-01-18 |
| VNS THERAPY SYSTEM (P970003/S208) | LivaNova USA, Inc. | 2017-01-18 |
| DEFLUX INJECTABLE GEL (P000029/S082) | Palette Life Sciences | 2017-01-18 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL (P080025/S129) | Medtronic Neuromodulation | 2017-01-18 |
| SYNVISC (P940015/S038) | Sanofi Genzyme Corp. | 2017-01-18 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S018) | Tandem Diabetes Care, Inc. | 2017-01-18 |
| SOLESTA INJECTABLE GEL (P100014/S019) | Palette Life Sciences | 2017-01-18 |
| SIR-SPHERES MICROSPHERES (P990065/S010) | Sirtex Medical, Inc. | 2017-01-18 |
| Sprint Quattro Lead Models 6935, 6944, 6947 (P920015/S192) | Medtronic, Inc. | 2017-01-18 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY INCONTINENCE (P970004/S234) | Medtronic Neuromodulation | 2017-01-18 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S272) | Boston Scientific Corp | 2017-01-17 |
| JUVEDERM VOLUMA XC AND JUVEDERM VOLBELLA XC (P110033/S025) | Allergan | 2017-01-17 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, Integra Omnigraft Dermal Regeneration (P900033/S059) | Integra Lifesciences Corp. | 2017-01-17 |
| RADIESSE INJECTABLE IMPLANT (P050037/S077) | Merz North America, Inc. | 2017-01-17 |
| JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS (P050047/S055) | Allergan | 2017-01-17 |
| HYDRASOFT CONTACT LENS (P850079/S071) | CooperVision, Inc. | 2017-01-17 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S060) | Medtronic Cryocath, LP | 2017-01-17 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S059) | Medtronic Vascular | 2017-01-17 |
| NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S011) | Nevro Corporation | 2017-01-17 |
| RADIESSE (+) LIDOCAINE DERMAL FILLER (P050052/S089) | Merz North America, Inc. | 2017-01-17 |
| Freezor CryoAblation System (P020045/S078) | Medtronic Cryocath, LP | 2017-01-17 |
| QuickFlex u and Quartet leads (P030054/S311) | ABBOTT MEDICAL | 2017-01-13 |
| IsoFlex Optim leads (P960030/S047) | ABBOTT MEDICAL | 2017-01-13 |
| Durata and Optisure leads (P950022/S095) | ABBOTT MEDICAL | 2017-01-13 |
| ENDURANT,ENDURANT II AND ENDURANT II AOTYO-UNI-LIAC (AUI) STENT GRAFT SYSTEM (P100021/S054) | Medtronic Vascular | 2017-01-13 |
| ASCENDA CATTHETER ORIENTATION (P860004/S266) | Medtronic, Inc. | 2017-01-13 |
| AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System (P930014/S096) | Alcon Laboratories, Inc. | 2017-01-13 |
| Tendril SDX, Tendril ST, Tendril STS and Optisense leads (P960013/S085) | ABBOTT MEDICAL | 2017-01-13 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S077) | Medtronic Vascular | 2017-01-13 |
| ELECSYS HBEAG AND PRECICONTROL HBEAG (P130015/S009) | Roche Diagnostics Operations, Inc. | 2017-01-13 |
| VISTAKON (SENOFILCON A) BRANDED CONTACT LENSES. (P040045/S064) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-01-12 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008) | Heartsine Technologies, Ltd. | 2017-01-12 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S048) | Zimmer, Inc. | 2017-01-12 |
| FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021/S003) | Abbott Diabetes Care, Inc. | 2017-01-12 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S042) | Smith & Nephew, Inc. | 2017-01-12 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S019) | Torax Medical | 2017-01-12 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S085) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-01-12 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S009) | Nevro Corporation | 2017-01-12 |
| EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S041) | Bioventus, LLC | 2017-01-12 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S005) | Medtronic Minimed | 2017-01-11 |
| Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, Momentum, and Perciva ICDs (P960040/S387) | Boston Scientific | 2017-01-11 |
| LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S030) | Lenstec, Inc. | 2017-01-11 |
| Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, and Momentum CRT-Ds (P010012/S442) | Boston Scientific Corp | 2017-01-11 |
| Fromio, Vitalio, Ingenio, Advantio, Altrua, Altrua 2, Accolade, Proponent and Essentio (N970003/S201) | Boston Scientific Corp | 2017-01-11 |
| Intua, Invive, Valitude, and Visionist CRT-Ps (P030005/S149) | Guidant Corp. | 2017-01-11 |
| MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S007) | Medtronic Minimed | 2017-01-11 |
| M-VU ALGORITHM ENGINE (P100005/S007) | Icad, Inc. | 2017-01-11 |
| Accolade MRI, Proponent MRI, and Essentio MRI (P150012/S024) | Boston Scientific | 2017-01-11 |
| Emblem and Emblem MRI S-ICDs (P110042/S073) | Boston Scientific Corporation | 2017-01-11 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S056) | W. L. Gore & Associates, Inc. | 2017-01-11 |
| STAR EXCIMER LASER SYSTEM (P930016/S049) | Amo Manufacturing USA, LLC | 2017-01-11 |
| INGEVITY NON-MRI LEAD & INGEVITY MRI LEAD (P150012/S023) | Boston Scientific | 2017-01-10 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S067) | Hologic, Inc. | 2017-01-10 |
| ACUITY X4 STRAIGHT/SPIRAL S/SPIRAL L MODELS (P010012/S441) | Boston Scientific Corp | 2017-01-10 |
| ENDOTAK RELIANCE SYSTEM (P910073/S140) | Boston Scientific | 2017-01-10 |
| VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S063) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-01-10 |
| PERCEVAL HEART VALVE (P150011/S006) | Corcym S.r.l. | 2017-01-10 |
| ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION (P160031) | Fujifilm Medical Systems U.S.A, Inc. | 2017-01-10 |
| Prodigy Leads and Extension Insertion Tool (P010032/S124) | ABBOTT MEDICAL | 2017-01-09 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S053) | W. L. Gore & Associates, Inc. | 2017-01-09 |
| Infinity Lead and Extension Insertion Tool (P140009/S020) | ABBOTT MEDICAL | 2017-01-09 |
| DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S098) | ABBOTT MEDICAL | 2017-01-08 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S022) | Boston Scientific | 2017-01-08 |
| QUICKFLEX U AND QUARTET LEADS (CRT) (P030054/S315) | ABBOTT MEDICAL | 2017-01-08 |
| ISOFLEX OPTIM LEADS (LV PASSIVE) (P960030/S049) | ABBOTT MEDICAL | 2017-01-08 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE) (P960013/S087) | ABBOTT MEDICAL | 2017-01-08 |
| ARCTIC FRONT & ARCTIC ADVANCED CARDIAC CRYOABLATIN CATHETER SYSTEM (P100010/S061) | Medtronic Cryocath, LP | 2017-01-06 |
| MINIMED 630G pump (P150001/S003) | Medtronic Minimed | 2017-01-06 |
| CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S004) | Cartiva, Inc. | 2017-01-06 |