| Cervista HPV 16/18 Assay (P080015/S014) | Hologic, Inc. | 2018-09-13 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S029) | Ventana Medical Systems, Inc. | 2018-09-13 |
| Visian Toric ICL (IMPLANTABLE COLLAMER LENS) (P030016/S001) | STAAR Surgical Company | 2018-09-13 |
| PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S038) | Ventana Medical Systems, Inc. | 2018-09-13 |
| Tridyne Vascular Sealant (P150016/S016) | Neomend, Inc. | 2018-09-13 |
| Cervista HPV HR Assay (P080014/S022) | Hologic, Inc. | 2018-09-13 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S009) | Ventana Medical Systems, Inc. | 2018-09-13 |
| Remede® System (P160039/S003) | Respicardia | 2018-09-12 |
| Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S073) | Integra Lifesciences Corp. | 2018-09-12 |
| Tridyne Vascular Sealant (P150016/S010) | Neomend, Inc. | 2018-09-12 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S011) | ABBOTT MEDICAL | 2018-09-12 |
| Progel Pleural Air Leak Sealant (P010047/S051) | Neomend, Inc. | 2018-09-12 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S040) | Beckman Coulter, Inc. | 2018-09-12 |
| Implantable System for Remodulin (P140032/S019) | Medtronic, Inc. | 2018-09-12 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S012) | ABBOTT MEDICAL | 2018-09-12 |
| Atellica IM anti-HBc Total (HBcT) (P040004/S014) | Siemens Healthcare Diagnostics | 2018-09-11 |
| Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory (P110041/S006) | Siemens Corp. | 2018-09-11 |
| Atellica IM Analyzer Hepatitis C (aHCV) (P030056/S013) | Siemens Healthcare Diagnostics | 2018-09-11 |
| Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2) (P100039/S006) | Siemens Healthcare Diagnostics, Inc. | 2018-09-11 |
| LCS Total Knee System (P830055/S207) | Depuy, Inc. | 2018-09-11 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S005) | Siemens Healthcare Diagnostics | 2018-09-11 |
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S013) | Siemens Healthcare Diagnostics | 2018-09-11 |
| ASCENSION MCP FINGER IMPLANT (P000057/S008) | Smith & Nephew, Inc. | 2018-09-10 |
| Mynx Control Vascular Closure Device (P040044/S079) | Cordis US Corporation | 2018-09-10 |
| Nucleus Hybrid Implant System (P130016/S035) | Cochlear Americas | 2018-09-10 |
| Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT ) (P100029/S035) | ABBOTT MEDICAL | 2018-09-10 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S004) | Celonova Biosciences, Inc. | 2018-09-10 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S024) | Lutonix | 2018-09-10 |
| Nucleus Auditory Brainstem Implant System (P000015/S033) | Cochlear Americas | 2018-09-10 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S027) | Cook Ireland, Ltd. | 2018-09-10 |
| Nucleus 24 Cochlear Implant System (P970051/S181) | Cochlear Americas | 2018-09-10 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S111) | Boston Scientific | 2018-09-07 |
| Impella CP/Impella CP with SmartAssist (P140003/S039) | Abiomed, Inc. | 2018-09-07 |
| PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Eeverolimus-Eluting Platinum Chromium Coronary Stent (P110010/S155) | Boston Scientific Corp | 2018-09-07 |
| Express SD Monorail Premounted Stent Systemt (P060006/S091) | Boston Scientific Corp | 2018-09-07 |
| Rotablator Rotational Atherectomy System (P900056/S170) | Boston Scientific Corp | 2018-09-07 |
| NeuroPace RNS System (P100026/S059) | NeuroPace, Inc. | 2018-09-07 |
| Propel and Propel Mini Sinus Implants (P100044/S034) | Intersect Ent. | 2018-09-07 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S108) | Boston Scientific Corp | 2018-09-07 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S033) | The Cooper Companies | 2018-09-07 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S085) | Boston Scientific Corp | 2018-09-07 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S036) | Boston Scientific Corp | 2018-09-07 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S050) | Boston Scientific Corp | 2018-09-07 |
| Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs (P090022/S035) | Lenstec, Inc. | 2018-09-06 |
| VenaSeal Closure System (P140018/S012) | Medtronic Vascular, Inc. | 2018-09-06 |
| Implantable System for Remodulin (P140032/S005) | Medtronic, Inc. | 2018-09-06 |
| AutoDELFIA hAFP Test Kit (P970037/S011) | Revvity, Inc. | 2018-09-06 |
| Oncomine Dx Target (P160045/S005) | Life Technologies Corporation | 2018-09-06 |
| LINX Reflux Management System (P100049/S023) | Torax Medical | 2018-09-06 |
| MynxGrip Vascular Closure Device, Mynx Ace Vascular Closure Device (P040044/S082) | Cordis US Corporation | 2018-09-06 |
| Micra TPS (P150033/S040) | Medtronic, Inc. | 2018-09-05 |
| Consulta CRT-P; Syncra CRT-P; Viva CRT-P (P010015/S377) | Medtronic, Inc. | 2018-09-05 |
| Protecta ICD, Protecta VR ICD, and Protecta XT ICD (P980016/S684) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| EMBLEM S-ICD & EMBLEM MRI S-ICD (P110042/S113) | Boston Scientific Corporation | 2018-09-05 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S072) | Edwards Lifesciences, LLC | 2018-09-05 |
| 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 (P010031/S642) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| Adapta, Versa, Sensia IPG; Astra XT DR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Attesta DR (P980035/S560) | Medtronic, Inc. | 2018-09-05 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S093) | Edwards Lifesciences, LLC | 2018-09-05 |
| Protecta CRT-D and Protectea XT CRT-D (P010031/S643) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| Evera MRI: DF-1 ICD, ICD; Evera S: DR ICD, VR ICD; Evera XT, DR ICD, VR ICD; Mirro MRI: DR ICD, VR ICD; Primo MRI: DR IC (P980016/S683) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| NeuroPace RNS System (P100026/S058) | NeuroPace, Inc. | 2018-09-05 |
| Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD, (P960040/S428) | Boston Scientific | 2018-09-04 |
| MiSeqDx Extended RAS Panel (P160038/S005) | Illumina, Inc. | 2018-09-04 |
| nGEN Pump (P990071/S037) | Biosense Webster, Inc. | 2018-09-04 |
| ORBERA Intragastric Balloon System (P140008/S008) | Boston Scientific Corporation | 2018-09-04 |
| Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Origen CRT-D, Origen X4 CRT-D, Autogen CRT-D, Autogen X4 (P010012/S489) | Boston Scientific Corp | 2018-09-04 |
| Torosa Saline Filled Testicular Prosthesis (P020003/S008) | Coloplast Corp. | 2018-09-04 |
| Emblem S-ICD, Emblem MRI S-ICD (P110042/S112) | Boston Scientific Corporation | 2018-09-04 |
| ZOLL R Series Device (P160022/S006) | ZOLL Medical Corporation | 2018-09-03 |
| LCS Total Knee System (P830055/S203) | Depuy, Inc. | 2018-08-31 |
| XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System (P110019/S101) | Abbott Vascular | 2018-08-31 |
| MiniMed 670G System (P160017/S050) | Medtronic Minimed, Inc. | 2018-08-31 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S050) | Coloplast Corp. | 2018-08-31 |
| Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, Sphera DR/SR MRI IPG (P980035/S559) | Medtronic, Inc. | 2018-08-31 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S404) | Medtronic Neuromodulation | 2018-08-30 |
| CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S067) | Integra Lifesciences Corp. | 2018-08-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Extensions and Leads) (P080025/S172) | Medtronic Neuromodulation | 2018-08-30 |
| SYNERGY Everolimus-Eluting Platinum Chrominum Coronary Stent System (P150003/S036) | Boston Scientific Corporation | 2018-08-30 |
| PROMUS PREMIER Everolimus-Eluting Platinum Chrominum Coronary Stent System (P110010/S151) | Boston Scientific Corp | 2018-08-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary Extensions and Leads) (P970004/S277) | Medtronic Neuromodulation | 2018-08-30 |
| Activa Deep Brain Stimulation Therapy System (P960009/S321) | Medtronic, Inc. | 2018-08-30 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S017) | Abbott Molecular, Inc. | 2018-08-29 |
| UroVysion Bladder Cancer Kit (P030052/S024) | Abbott Molecular | 2018-08-29 |
| INFUSE Bone Graft (P000054/S050) | Medtronic Sofamor Danek USA, Inc. | 2018-08-29 |
| Vysis CLL FISH Probe Kit (P150041/S004) | Abbott Molecular, Inc. | 2018-08-29 |
| INFUSE Bone Graft/LT-Cage Lumbar Tampered Fusion Device (P000058/S069) | Medtronic Sofamor Danek USA, Inc. | 2018-08-29 |
| PathVysion HER-2 DNA Probe Kit (P980024/S019) | Abbott Molecular, Inc. | 2018-08-29 |
| ZILVER PTX Drug-Eluting Peripheral Stent. (P100022/S028) | Cook Ireland, Ltd. | 2018-08-29 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S022) | Lutonix | 2018-08-29 |
| HiRes Ultra 3D Cochlear Implant (P960058/S129) | Advanced Bionics | 2018-08-28 |
| Livewire TC Ablation Catheter (P960016/S075) | St Jude Medical | 2018-08-28 |
| Cartiva SCI reusable instrumentation (P150017/S007) | Cartiva, Inc. | 2018-08-28 |
| Impella 2.5, Impella CP, Impella 5.0 and Impella LD (P140003/S038) | Abiomed, Inc. | 2018-08-28 |
| Bellafill Dermal Filler (P020012/S014) | Tiger Aesthetics Medical, LLC | 2018-08-28 |
| Lotrafilcon A and Lotrafilcon B Soft Contact Lenses (P010019/S068) | Alcon Laboratories, Inc. | 2018-08-28 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P070008/S096) | Biotronik, Inc. | 2018-08-27 |
| LifeStent 5F Vascular Stent System (P070014/S058) | Bard Peripheral Vascular, Inc. | 2018-08-27 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P050023/S123) | Biotronik, Inc. | 2018-08-27 |
| Bellafill Dermal Filler (P020012/S021) | Tiger Aesthetics Medical, LLC | 2018-08-27 |
| Covera Vascular Covered Stent (P170042/S001) | C.R. Bard, Inc. | 2018-08-27 |