| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S100) | Medtronic Vascular | 2019-09-16 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S024) | Gen-Probe Incorporated | 2019-09-16 |
| Aptima HPV Assay (P100042/S026) | Gen-Probe Incorporated | 2019-09-16 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S034) | Cook Ireland, Ltd. | 2019-09-13 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S053) | Boston Scientific Corporation | 2019-09-13 |
| Implantable Pulse Generator (IPG), Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precisi (P030017/S329) | Boston Scientific Corp | 2019-09-13 |
| The SENSAR/TECNIS 1-Piece IOL with SmartLOAD Delivery Technology and The TECNIS OptiBlue 1-Piece IOL with SmartLOAD Deli (P980040/S095) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| Lutonix Drug Coated Balloon PTA Catheter (P130024/S029) | Lutonix | 2019-09-13 |
| Innova Self-Expanding Stent System (P140028/S042) | Boston Scientific Corporation | 2019-09-13 |
| Hydro Thermablator Endometrial Ablation (P000040/S037) | Axora Medical, Inc. | 2019-09-13 |
| Precision Spectra and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems (P030017/S327) | Boston Scientific Corp | 2019-09-13 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Ballon (P160049/S007) | The Spectranetics Corp. | 2019-09-13 |
| CapSureFix Novus Lead (P930039/S204) | Medtronic, Inc. | 2019-09-13 |
| In.Pact Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S047) | Medtronic, Inc. | 2019-09-13 |
| Epic Vascular Self-Expanding Stent System (P110035/S052) | Boston Scientific Corp | 2019-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S011) | Boston Scientific Corp | 2019-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S014) | Boston Scientific Corp | 2019-09-13 |
| Evera MRI DF-1, MRI, S DR, S VR, XT DR, XT VR, Mirro MRI DR, MRI VR, Primo MRI DR, MRI VR, Visia AF MRI DF1, AF MRI VR, (P980016/S718) | Medtronic Cardiac Rhythm Disease Management | 2019-09-13 |
| Restylane Refyne, Restylane Defyne (P140029/S020) | Q-Med AB | 2019-09-13 |
| Amplia MRI, MRI Quad, Brava, Brava Quad, Claria MRI, MRI Quad, Compia MRI, MRI Quad, and Viva Quad S, Quad XT, S, XT CRT (P010031/S679) | Medtronic Cardiac Rhythm Disease Management | 2019-09-13 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack (P110042/S127) | Boston Scientific Corporation | 2019-09-13 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S023) | ABBOTT MEDICAL | 2019-09-12 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P150021/S045) | Abbott Diabetes Care, Inc. | 2019-09-12 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test V2.0 (P060030/S079) | Roche Molecular Systems, Inc. | 2019-09-12 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S075) | ABBOTT MEDICAL | 2019-09-12 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S078) | Roche Molecular Systems, Inc. | 2019-09-12 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S049) | Roche Molecular Systems, Inc. | 2019-09-12 |
| HEMOBLAST Bellows (P170012/S019) | Dilon Technologies, Inc. | 2019-09-12 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S023) | Boston Scientific Corp | 2019-09-12 |
| Oxford Partial Knee System (P010014/S092) | Biomet Manufacturing Corp | 2019-09-12 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses (P170035/S006) | Bausch and Lomb, Inc., | 2019-09-12 |
| Freestyle Libre Pro Flash Glucose Monitoring System (P160030/S038) | Abbott Diabetes Care, Inc. | 2019-09-12 |
| BOND Oracel HER2 IHC System (P090015/S008) | Leica Biosystems | 2019-09-12 |
| AUGMENT Bone Graft and AUGMENT Injectable (P100006/S009) | Biomimetic Therapeutics, LLC | 2019-09-11 |
| Oxford Partial Knee System (P010014/S091) | Biomet Manufacturing Corp | 2019-09-11 |
| TECNIS iTEC Preloaded Delivery System (P980040/S106) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-11 |
| EnVeo R and PRO Delivery Catheter System (P130021/S063) | Medtronic, Inc. | 2019-09-11 |
| OraQuick HCV Rapid Antibody Test (P080027/S035) | OraSure Technologies, Inc. | 2019-09-11 |
| MitraClip NTR, XTR and G4 Clip Delivery System (P100009/S035) | ABBOTT MEDICAL | 2019-09-11 |
| Inspire Upper Airway Stimulation System (P130008/S046) | Inspire Medical Systems | 2019-09-11 |
| InterStim Therapy System, Verify Evaluation System (P970004/S294) | Medtronic Neuromodulation | 2019-09-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S189) | Medtronic Neuromodulation | 2019-09-11 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S097) | CooperVision, Inc. | 2019-09-10 |
| Xience Xpedition Everolimus Eluting Coronary Stent System and Xience Alpine Everolimus Eluting Coronary Stent System (P110019/S107) | Abbott Vascular | 2019-09-10 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S038) | The Cooper Companies | 2019-09-10 |
| Superion Indirect Decompression System (P140004/S014) | Boston Scientific Neuromodulation | 2019-09-10 |
| polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S062) | CooperVision, Inc. | 2019-09-10 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S007) | Bard Peripheral Vascular, Inc. | 2019-09-09 |
| Proclaim Spinal Cord Stimulation (SCS) IPG Family (P010032/S151) | ABBOTT MEDICAL | 2019-09-09 |
| STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio (P930016/S057) | Amo Manufacturing USA, LLC | 2019-09-09 |
| Cologuard (P130017/S032) | Exact Sciences Corporation | 2019-09-06 |
| Axonics Sacral Neuromodulation System (P190006) | Boston Scientific Corporation | 2019-09-06 |
| enVista Hydrophobic Acrylic Intraocular Lens (P910056/S037) | Bausch & Lomb, Inc. | 2019-09-06 |
| SynchroMed Infusion System (P860004/S325) | Medtronic, Inc. | 2019-09-06 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S010) | Boston Scientific Corp | 2019-09-06 |
| Innova Vascular Self-Expanding Stent System (P140028/S043) | Boston Scientific Corporation | 2019-09-06 |
| HeartWare Left Ventricular Assist Device System (P100047/S145) | Medtronic | 2019-09-06 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S086) | Integra Lifesciences Corp. | 2019-09-06 |
| Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S084) | CooperVision, Inc. | 2019-09-05 |
| M6-C Artificial Cervical Disc (P170036/S003) | Spinal Kinetics, LLC | 2019-09-05 |
| Logicon Caries Detection Software (P980025/S004) | Carestream Dental, LLC | 2019-09-05 |
| Titan Inflatable Penile Prosthesis (P000006/S051) | Coloplast Corp. | 2019-09-05 |
| VNS Therapy System (P970003/S226) | LivaNova USA, Inc. | 2019-09-05 |
| BioGlue Surgical Adhesive (P010003/S035) | Cryolife, Inc. | 2019-09-05 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S050) | ABBOTT MEDICAL | 2019-09-05 |
| Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S096) | CooperVision, Inc. | 2019-09-05 |
| BD FocalPoint GS Imaging System (P950009/S022) | Bd Diagnostics | 2019-09-05 |
| Quadra Assura, Unify, Unify Assura, and Unify Quadra CRT-D Devices (P030054/S370) | ABBOTT MEDICAL | 2019-09-04 |
| cobas HBV Test (P150014/S031) | Roche Molecular Systems, Inc. | 2019-09-04 |
| Implantable System for Remodulin (P140032/S040) | Medtronic, Inc. | 2019-09-04 |
| ENROUTE Transcarotid Stent System (P140026/S013) | Boston Scientific Corporation | 2019-09-04 |
| Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T (P000009/S080) | Biotronik, Inc. | 2019-09-04 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S022) | Boston Scientific Corp | 2019-09-04 |
| Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX (P980023/S093) | Biotronik, Inc. | 2019-09-04 |
| Deep Brain Stimulation Therapy System for Parkinson's Disease (P960009/S357) | Medtronic, Inc. | 2019-09-04 |
| Ilivia Neo 7 HF -T, Intica Neo 7 and 5 HF -T, Ilivia Neo 7 HF -T QP, and Intica Neo 7 and 5 HF -T QP (P050023/S133) | Biotronik, Inc. | 2019-09-04 |
| Cobas CMV (P160041/S024) | Roche Molecular Systems, Inc. | 2019-09-04 |
| cobas HCV (P150015/S033) | Roche Molecular Systems, Inc. | 2019-09-04 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S339) | Medtronic, Inc. | 2019-09-04 |
| Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices (P910023/S418) | ABBOTT MEDICAL | 2019-09-04 |
| ThinPrep 5000 Processor (P950039/S038) | Hologic, Inc. | 2019-09-03 |
| LifeVest Wearable Defibrillator (P010030/S125) | Zoll Manufacturing Corporation | 2019-09-03 |
| Staumann Emdogain (P930021/S025) | The Straumann Company | 2019-09-03 |
| cobas HPV (P100020/S048) | Roche Molecular Systems, Inc. | 2019-09-03 |
| Advisa DR MRI and Advisa DR/DR MRI IPG (P980035/S604) | Medtronic, Inc. | 2019-08-30 |
| Protecta ICD, Protecta VR, XT ICD and Secura ICD, Secura DR ICD (P980016/S717) | Medtronic Cardiac Rhythm Disease Management | 2019-08-30 |
| Epi proColon (P130001/S005) | New Day Diagnostics, LLC | 2019-08-30 |
| Consulta, Protecta and Protecta XT CRT-D (P010031/S678) | Medtronic Cardiac Rhythm Disease Management | 2019-08-30 |
| Consulta, Synca and Viva CRT-P (P010015/S418) | Medtronic, Inc. | 2019-08-30 |
| Tendril MRI Steroid Eluting Cardiac Leads (P140033/S046) | ABBOTT MEDICAL | 2019-08-30 |
| HiResolution Bionic Ear System (P960058/S131) | Advanced Bionics | 2019-08-30 |
| AMS 700 Inflatable Penile Prosthesis, and AMS Ambicor Inflatable Penile Prosthesis (N970012/S166) | Boston Scientific Corp | 2019-08-30 |
| AMS 800 Artificial Urinary Sphincter (P000053/S106) | Boston Scientific Corp | 2019-08-30 |
| MitraClip NT, NTR, XTR, G4 Clip Delivery System (P100009/S034) | ABBOTT MEDICAL | 2019-08-30 |
| Lotrafilcon A and B Soft Contact Lenses (P010019/S073) | Alcon Laboratories, Inc. | 2019-08-30 |
| Deflux Injectable Gel (P000029/S085) | Palette Life Sciences | 2019-08-29 |
| Eversense Continuous Glucose Monitoring System (P160048/S011) | Senseonics, Incorporated | 2019-08-29 |
| Juvederm Voluma XC (P110033/S042) | Allergan | 2019-08-29 |
| Solesta Injectable Gel (P100014/S022) | Palette Life Sciences | 2019-08-29 |
| Eversense Continuous Glucose Monitoring System (P160048/S013) | Senseonics, Incorporated | 2019-08-29 |