| Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse, Kappa (P980035/S584) | Medtronic, Inc. | 2019-06-11 |
| Micra (P150033/S052) | Medtronic, Inc. | 2019-06-11 |
| MyCareLink Firmware (P890003/S408) | Medtronic, Inc. | 2019-06-11 |
| Viva, Brava, Protecta, XT, Concerto, Concerto II, Maximo II, InSync II Protect, Amplia, Compia, Claria (P010031/S662) | Medtronic Cardiac Rhythm Disease Management | 2019-06-11 |
| Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve (P150048/S036) | Edwards Lifesciences, LLC | 2019-06-11 |
| Edwards Intuity Elite Valve System (P150036/S040) | Edwards Lifesciences, LLC | 2019-06-11 |
| LATITUDE Wave Communicator (P910077/S171) | Boston Scientific | 2019-06-10 |
| CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, (P010012/S501) | Boston Scientific Corp | 2019-06-10 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S094) | CooperVision, Inc. | 2019-06-10 |
| Subcutaneous ICD Devices: EMBLEM (P110042/S125) | Boston Scientific Corporation | 2019-06-10 |
| CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S183) | Guidant Corp. | 2019-06-10 |
| Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S075) | Boston Scientific | 2019-06-10 |
| Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA II supported (N970003/S238) | Boston Scientific Corp | 2019-06-10 |
| Bellafill Derma Filler (P020012/S027) | Tiger Aesthetics Medical, LLC | 2019-06-10 |
| ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S436) | Boston Scientific | 2019-06-10 |
| PD-L1 IHC 22C3 pharmDx (P150013/S014) | Agilent Technologies, Inc. | 2019-06-10 |
| Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S083) | CooperVision, Inc. | 2019-06-10 |
| Durolane, Hyaluronic Acid, Stabilized Single Injection (P170007/S003) | Bioventus, LLC | 2019-06-08 |
| R3 delta Ceramic Acetabular System (P150030/S007) | Smith & Nephew, Inc. | 2019-06-07 |
| MED-EL Cochlear Implant (P000025/S100) | Med-El Corp. | 2019-06-07 |
| H.E.L.P. Futura Apheresis System (P940016/S027) | B. Braun Avitum AG | 2019-06-07 |
| Radiesse (+) Lidocaine Dermal Filler (P050052/S113) | Merz North America, Inc. | 2019-06-07 |
| Radiesse Injectable Implant (P050037/S097) | Merz North America, Inc. | 2019-06-07 |
| Coaptite Injectable Implant (P040047/S054) | Merz North America, Inc. | 2019-06-07 |
| Radiesse Injectable Implany and Radiesse (+) Lidocaine Dermal Filler (P050052/S114) | Merz North America, Inc. | 2019-06-07 |
| Vistakon (etafilcon A) Brand Contact Lenses (N18033/S105) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-06-07 |
| Radiesse Injectable Implant (P050037/S096) | Merz North America, Inc. | 2019-06-07 |
| Coaptite Injectable Implant (P040047/S053) | Merz North America, Inc. | 2019-06-07 |
| Cobas HCV (P150015/S030) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas CMV (P160041/S022) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Consulta CRT-P; Syncra CRT-P, Viva CRT-P (P010015/S397) | Medtronic, Inc. | 2019-06-06 |
| HeartWare Left Ventricular Assist System (P100047/S129) | Medtronic | 2019-06-06 |
| Radiesse 1.5cc and 0.8cc (P050037/S095) | Merz North America, Inc. | 2019-06-06 |
| Restylane-L (P040024/S106) | Q-Med AB | 2019-06-06 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029) | Philips Medical Systems, Inc. | 2019-06-06 |
| Adapta,Versa, Sensia IPG, Advisa DR IPG, DR MRI IPG, SR MRI IPG, Relia IPG, Sphera DR MRI IPG (P980035/S581) | Medtronic, Inc. | 2019-06-06 |
| Cobas HCV (P150015/S031) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Cobas HBV (P150014/S028) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Onyx Liquid Embolic System (P030004/S018) | Ev3 Neurovascular | 2019-06-06 |
| Eversense Continuous Glucose Monitoring System (P160048/S006) | Senseonics, Incorporated | 2019-06-06 |
| Cobas CMV (P160041/S021) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Radiesse (+) Lidocaine Dermal Filler (1.5cc and 0.8cc) (P050052/S112) | Merz North America, Inc. | 2019-06-06 |
| Cobas HBV (P150014/S029) | Roche Molecular Systems, Inc. | 2019-06-06 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S020) | Boston Scientific Corp | 2019-06-05 |
| PRO-Kinetic Energy Coronary Stent System, Papyrus (P160003/S008) | Biotronik AG | 2019-06-05 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro/Primo MRI DR/VR ICD, Protecta ICD, Prote (P980016/S708) | Medtronic Cardiac Rhythm Disease Management | 2019-06-05 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brav CRT-D, Brava Quad CRT-D, Claria MRi CRT-D, Claria MRI Quad CRT-D, Compia M (P010031/S668) | Medtronic Cardiac Rhythm Disease Management | 2019-06-05 |
| Nucleus Hybrid Cochlear Implant System (P130016/S036) | Cochlear Americas | 2019-06-05 |
| Nucleus ABI541 Auditory Brainstem Implant (P000015/S034) | Cochlear Americas | 2019-06-05 |
| Nucleus 24 Cochlear Implant System (P970051/S182) | Cochlear Americas | 2019-06-05 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System and WATCHMAN Access System (P130013/S030) | Boston Scientific Corp | 2019-06-04 |
| CareLink SmartSync Device Manager (P980035/S583) | Medtronic, Inc. | 2019-06-04 |
| CapSure Sense Leads (P830061/S169) | Medtronic Cardiac Rhythm Disease Management | 2019-06-04 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S088) | Edwards Lifesciences, LLC | 2019-06-04 |
| HeartMate 3 Left Ventricular Assist System (P160054/S017) | ABBOTT MEDICAL | 2019-06-04 |
| Arctic Front Advance Cardiac Cryoablation Catheters (P100010/S094) | Medtronic Cryocath, LP | 2019-06-04 |
| Revanesse Versa and Revanesse Versa+ (P160042/S009) | Prollenium Medical Technologies, Inc. | 2019-06-04 |
| Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant (P000025/S110) | Med-El Corp. | 2019-06-04 |
| Hintermann Series H3 Total Ankle Replacement System (P160036) | Dt Medtech, LLC | 2019-06-04 |
| LOTUS Edge Valve System (P180029/S001) | Boston Scientific Corporation | 2019-06-04 |
| CareLink SmartSync Azure Astra Application (P890003/S406) | Medtronic, Inc. | 2019-06-04 |
| CapSureFix Novus Leads (P930039/S198) | Medtronic, Inc. | 2019-06-04 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S436) | Medtronic Neuromodulation | 2019-06-03 |
| ADEPT Adhesion Reduction Solution (P050011/S006) | Baxter Healthcare Corp | 2019-06-03 |
| ORBERA Intragastric Balloon System (P140008/S017) | Boston Scientific Corporation | 2019-06-03 |
| Activa Deep Brain Stimulation Therapy System (P960009/S350) | Medtronic, Inc. | 2019-06-03 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S185) | Medtronic Neuromodulation | 2019-06-03 |
| Implantable Pluse Generator (IPG): Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S016) | Boston Scientific Corp | 2019-06-03 |
| AngioJet Ultra Thrombectomy System (P980037/S073) | Boston Scientific Corp | 2019-06-03 |
| Micra Transcatheter Pacing System (TPS) (P150033/S051) | Medtronic, Inc. | 2019-06-03 |
| MitraClip System (NTR and XTR) (P100009/S030) | ABBOTT MEDICAL | 2019-06-03 |
| Implantable System for Remodulin (P140032/S034) | Medtronic, Inc. | 2019-06-03 |
| Implantable Pulse Generator (IPG) Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision (P030017/S324) | Boston Scientific Corp | 2019-06-03 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S332) | Medtronic, Inc. | 2019-06-03 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S290) | Medtronic Neuromodulation | 2019-06-03 |
| Impella CP with SmartAssist (P140003/S052) | Abiomed, Inc. | 2019-06-02 |
| Algovita Spinal Cord Stimulation (SCS): 12-Electrode Percutaneous Leads, and Trial Leads (P130028/S023) | Nuvectra Corporation | 2019-05-31 |
| VISTAKON (etafilcon A) Brand Contact Lenses. (N18033/S101) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-05-31 |
| Avalus Bioprosthesis (P170006/S012) | Medtronic, Inc. | 2019-05-31 |
| Propel Contour Sinus Implant (P100044/S041) | Intersect Ent. | 2019-05-31 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S093) | CooperVision, Inc. | 2019-05-31 |
| Organ Care System (OCS) Lung System (P160013/S002) | TransMedics, Inc. | 2019-05-31 |
| Propel Contour Sinus Implant (P100044/S040) | Intersect Ent. | 2019-05-31 |
| Relay Thoracic Stent-Graft With Plus Delivery System (P110038/S022) | Bolton Medical, Inc. | 2019-05-31 |
| prodisc C Total Disc Replacement (P070001/S017) | Centinel Spine, LLC | 2019-05-31 |
| Activa Deep Brain Stimulation Therapy System (P960009/S349) | Medtronic, Inc. | 2019-05-30 |
| Evera MRI XT DR/VR SureScan, Evera MRI S DR/VR SureScan and Visia AF MRI VR SureScan and Implantable Cardioverter Defibr (P980016/S707) | Medtronic Cardiac Rhythm Disease Management | 2019-05-30 |
| Torque Wrench/Torque Driver (P910023/S416) | ABBOTT MEDICAL | 2019-05-30 |
| Wallstent Iliac Endoprostehsis with Unistep Plus Delivery System (P940019/S055) | Boston Scientific Scimed, Inc. | 2019-05-30 |
| iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043/S004) | Glaukos Corporation | 2019-05-30 |
| Incraft AAA Stent Graft System (P150002/S002) | Cordis US Corporation | 2019-05-30 |
| Amplia MRI CRT-D SureScan, Amplia MRI Quad CRT-D SureScan, Compia MRI CRT-D SureScan, Compia MRI Quad CRT-D SureScan and (P010031/S667) | Medtronic Cardiac Rhythm Disease Management | 2019-05-30 |
| Wallstent Venous Endoprosthesis with UNISTEP Plus (P980033/S054) | Boston Scientific Corporation | 2019-05-30 |
| CapSureFix Novus MRI SureScan Lead (P930039/S197) | Medtronic, Inc. | 2019-05-30 |
| Medtronic Revo MRI SureScan IPG and Pacing System (P980035/S587) | Medtronic, Inc. | 2019-05-30 |
| Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le (P840001/S435) | Medtronic Neuromodulation | 2019-05-30 |
| Sprint Quattro Secure S MRI SureScan Lead and Sprint Quattro Secure MRI SureScan Lead (P920015/S229) | Medtronic, Inc. | 2019-05-30 |
| Wallstent TIPS Endoprosthesis with UNISTEP Plus (P930031/S064) | Boston Scientific Corp | 2019-05-30 |
| CapSureFix MRI Surescan Lead (P090013/S298) | Medtronic, Inc. | 2019-05-30 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S178) | Boston Scientific Corp | 2019-05-30 |