| Allure Quadra, Quadra Allure MP, Frontier (P030035/S154) | ABBOTT MEDICAL | 2017-10-20 |
| Activa Deep Brain Stimulation Therapy System (P960009/S297) | Medtronic, Inc. | 2017-10-20 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S381) | ABBOTT MEDICAL | 2017-10-20 |
| Implantable Miniature Telescope (P050034/S019) | Samsara Vision, Inc. | 2017-10-20 |
| Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD (P980016/S643) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Anthem, Allure/RF, Quadra Allure /RF family ofCRT-Ps (P030035/S153) | ABBOTT MEDICAL | 2017-10-20 |
| Assurity, Endurity, Accent, AddVent, Identity, Entity, Paragon III Sustain (P880086/S280) | ABBOTT MEDICAL | 2017-10-20 |
| Amplia MRI CRT-D/Amplia MRI Quad CRT-D/Brava CRT-D/Brava Quad CRT-D/Claria MRI CRT-D/Claria MRI Quad CRT-D/Compia MRI CR (P010031/S604) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Merlin Patient Care System Programmer (P030054/S327) | ABBOTT MEDICAL | 2017-10-20 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S083) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-10-20 |
| ProDisc-C Total Disc Replacement (P070001/S016) | Centinel Spine, LLC | 2017-10-20 |
| Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF (P030054/S321) | ABBOTT MEDICAL | 2017-10-20 |
| Microny SR+ Regency SC+ (P970013/S070) | ABBOTT MEDICAL | 2017-10-20 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S095) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-10-20 |
| LPS-Flex Mobile and LPS Mobioe Bearing Knee System (P060037/S052) | Zimmer, Inc. | 2017-10-19 |
| Percepta Quad CRT-P MRI SureScan / Percepta CRT-P MRI SureScan / Serena Quad CRT-P MRI SureScan / Splar Quad CRT-P MRI S (P010015/S340) | Medtronic, Inc. | 2017-10-19 |
| Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD (P980016/S642) | Medtronic Cardiac Rhythm Disease Management | 2017-10-19 |
| LCS Total Knee System (P830055/S191) | Depuy, Inc. | 2017-10-19 |
| MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C (P890003/S378) | Medtronic, Inc. | 2017-10-19 |
| Amplia MRI CRT-D/Amplia MRI Quad CRT-D/Brava CRT-D/Brava Quad CRT-D/Claria MRI CRT-D/Claria MRI Quad CRT-D/Compia MRI CR (P010031/S603) | Medtronic Cardiac Rhythm Disease Management | 2017-10-19 |
| RHA 2, RHA 3, RHA 4 (P170002) | Teoxane S.A. | 2017-10-19 |
| LCS Total Knee System (P830055/S189) | Depuy, Inc. | 2017-10-18 |
| Fortify / Fortify Assura / Ellipse (P910023/S394) | ABBOTT MEDICAL | 2017-10-18 |
| Unify / Unify Quadra / Unify Assura / Quadra Assura / Quadra Assura MP (P030054/S338) | ABBOTT MEDICAL | 2017-10-18 |
| LCS Total Knee System (P830055/S190) | Depuy, Inc. | 2017-10-18 |
| Durata and Optisure High Voltage Lead (P950022/S110) | ABBOTT MEDICAL | 2017-10-18 |
| Valitude / Valitude X4 / Visionist / Visionist X4 / Accolade Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices (P030005/S162) | Guidant Corp. | 2017-10-18 |
| Altrua / Essentio / Proponent / Accolade / Accolade Non-MRI Pacemakers (N970003/S214) | Boston Scientific Corp | 2017-10-18 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S148) | W. L. Gore & Associates, Inc. | 2017-10-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S298) | Medtronic, Inc. | 2017-10-18 |
| Essentio MRI / Proponent MRI / Accolade MRI / Accp;ade MRI Pacemakers (P150012/S040) | Boston Scientific | 2017-10-18 |
| Methafilcon A and Methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S075) | CooperVision, Inc. | 2017-10-17 |
| LOTRAFILCON A & B SOFT CONTACT LENSES (P010019/S053) | Alcon Laboratories, Inc. | 2017-10-17 |
| Tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (N17679/S037) | CooperVision, Inc. | 2017-10-17 |
| Stockert 70 Radio Frequency Ablation Generator (P990071/S038) | Biosense Webster, Inc. | 2017-10-17 |
| Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight (P030004/S013) | Ev3 Neurovascular | 2017-10-17 |
| Navistar Thermo Cool Deflectable Diagnostic/Ablation Catheter (P040036/S061) | Biosense Webster, Inc. | 2017-10-17 |
| Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters (P030031/S084) | Biosense Webster, Inc. | 2017-10-17 |
| Webster Diag./Ablation Deflectable Tip Catheter (P950005/S068) | Biosense Webster, Inc. | 2017-10-17 |
| Navi-Star Diagnostic/Ablation Deflectable Tip Catheter (P990025/S055) | Biosense Webster, Inc. | 2017-10-17 |
| Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter (P010068/S056) | Biosense Webster, Inc. | 2017-10-17 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S279) | Boston Scientific Corp | 2017-10-17 |
| AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set (P980037/S066) | Boston Scientific Corp | 2017-10-16 |
| Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-36Q; Fortify CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Ass (P910023/S393) | ABBOTT MEDICAL | 2017-10-16 |
| MiniMed 670G System/ Guardian Sensor (3) (P160017/S016) | Medtronic Minimed, Inc. | 2017-10-16 |
| ETI-AB-EBK PLUS assay (P990041/S023) | DiaSorin, Inc. | 2017-10-16 |
| Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262; (P030035/S160) | ABBOTT MEDICAL | 2017-10-16 |
| Microny 2525T (P970013/S073) | ABBOTT MEDICAL | 2017-10-16 |
| MiniMed 630G System with SmartGuard / Guardian Sensor (3) (P150001/S020) | Medtronic Minimed | 2017-10-16 |
| Assurity MRI PM1272, PM2272; Endurity MRI PM1172, PM2172 (P140033/S015) | ABBOTT MEDICAL | 2017-10-16 |
| EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) (P110042/S093) | Boston Scientific Corporation | 2017-10-16 |
| ETI-AB-AUK PLUS assay (P990042/S020) | DiaSorin, Inc. | 2017-10-16 |
| ETI-AB-COREK PLUS assay (P990045/S021) | DiaSorin, Inc. | 2017-10-16 |
| ETI-EBK PLUS assay (P990043/S024) | DiaSorin, Inc. | 2017-10-16 |
| Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240; (P880086/S288) | ABBOTT MEDICAL | 2017-10-16 |
| ETI MAK-2 PLUS and HBsAg Confirmatory Test assays (P990038/S024) | DiaSorin, Inc. | 2017-10-16 |
| Durata and Optisure Family of High Voltage Leads (P950022/S111) | ABBOTT MEDICAL | 2017-10-16 |
| Promote+ CD3211-36, CD3211-36Q; Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, (P030054/S337) | ABBOTT MEDICAL | 2017-10-16 |
| Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit (P140023/S011) | Roche Molecular Systems, Inc. | 2017-10-16 |
| ETI-CORE-IGMK PLUS assay (P990044/S021) | DiaSorin, Inc. | 2017-10-16 |
| MedStream Programmable Infusion Pump Control Unit (P890055/S070) | Intera Oncology | 2017-10-16 |
| COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S032) | Roche Molecular Systems, Inc. | 2017-10-13 |
| Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test (P110020/S022) | Roche Molecular Systems, Inc. | 2017-10-13 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S060) | Roche Molecular Systems, Inc. | 2017-10-13 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S002) | Bard Peripheral Vascular, Inc. | 2017-10-13 |
| Roche cobas EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit (P120019/S015) | Roche | 2017-10-13 |
| COBAS TaqMan HBV Test / High Pure System Viral Nucleic Acid Kit (P050028/S058) | Roche Molecular Systems, Inc. | 2017-10-13 |
| PROPEL Contour SInus Implant (P100044/S031) | Intersect Ent. | 2017-10-13 |
| NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S022) | Allergan | 2017-10-13 |
| Resolute Integrity RX Coronary Stent System & Resolute Integrity OTW Cornary Stent System (P110013/S082) | Medtronic Vascular | 2017-10-13 |
| ExAblate Neuro Thalamotomy (P150038/S004) | Insightec | 2017-10-13 |
| Ovation iX Abdominal Stent Graft System (P120006/S028) | Endologix, LLC | 2017-10-13 |
| cobas CMV test for use on the cobas 6800/8800 System (P160041/S002) | Roche Molecular Systems, Inc. | 2017-10-13 |
| cobas HBV Test (P150014/S009) | Roche Molecular Systems, Inc. | 2017-10-13 |
| Cobas HCV Test (P150015/S008) | Roche Molecular Systems, Inc. | 2017-10-13 |
| NATRELLE Saline-Filled Breast Implants (P990074/S038) | Allergan | 2017-10-13 |
| NATRELLE Silicone Filled Breast Implants (P020056/S041) | Allergan | 2017-10-13 |
| Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems (P080004/S018) | Hoya Surgical Optics, Inc. | 2017-10-13 |
| DRG Lead Extension Kit (P150004/S015) | ABBOTT MEDICAL | 2017-10-13 |
| PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende (P010047/S047) | Neomend, Inc. | 2017-10-12 |
| Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS) (P160054/S001) | ABBOTT MEDICAL | 2017-10-12 |
| HeartMate 3 Left Ventricular Assist System (P160054/S002) | ABBOTT MEDICAL | 2017-10-12 |
| PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory (P010047/S048) | Neomend, Inc. | 2017-10-12 |
| Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS) (P060040/S068) | ABBOTT MEDICAL | 2017-10-12 |
| HeartMate II Left Ventricular Assist System (P060040/S069) | ABBOTT MEDICAL | 2017-10-12 |
| Chilli II (P980003/S080) | Boston Scientific Corp | 2017-10-11 |
| Blazer II XP/ Blazer Prime XP / Intella Tip MiFi XP / IntellaNav, IntellaNav MiFi XP (P020025/S107) | Boston Scientific | 2017-10-11 |
| Pipeline Flex Embolization Device (P100018/S016) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-10-11 |
| Medtronic MiniMed 630G Insulin Pump (P150001/S023) | Medtronic Minimed | 2017-10-11 |
| Blazer OI / IntellaNav OI / Intella Tip MiFi OI (P150005/S028) | Boston Scientific Corp | 2017-10-11 |
| Medtronic MiniMed 67G Insulin Pump (P160017/S019) | Medtronic Minimed, Inc. | 2017-10-11 |
| IMMULITE / IMMULITE 1000 Third Generation PSA (P930027/S018) | Siemens Healthcare Diagnostics, Inc. | 2017-10-11 |
| Blazer II HTD / Blazer Prime HTD (P920047/S103) | Boston Scientific Corp | 2017-10-11 |
| MINIMED 530G SYSTEM (P120010/S101) | Medtronic, Inc. | 2017-10-11 |
| ICDs: PUNCTUA, ENERGEN, INCEPTA (P960040/S404) | Boston Scientific | 2017-10-11 |
| GORE CARDIOFORM Septal Occluder (P050006/S058) | W. L. Gore & Associates, Inc. | 2017-10-11 |
| Restylane Silk (P040024/S096) | Q-Med AB | 2017-10-11 |
| CRT-Ds: DYNAGEN, VIGILANT, MOMENTUM (P010012/S463) | Boston Scientific Corp | 2017-10-11 |
| Mentor MemoryGel Silicone Gel - Filled Breast Implants (P030053/S043) | Mentor Corp. | 2017-10-10 |
| GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P130006/S043) | W. L. Gore & Associates, Inc. | 2017-10-10 |