| EVO/EVO+VISIAN Implantable Collamer Lens (P030016/S035) | STAAR Surgical Company | 2022-03-25 |
| Stellarex 0.035OTW Drug-coated Angioplasty Balloon (P160049/S015) | The Spectranetics Corp. | 2022-03-25 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S422) | Medtronic, Inc. | 2022-03-25 |
| CT Lucia 602, CT Lucia 202, CT Lucia 611P (P100016/S012) | Carl Zeiss Meditec Production, LLC | 2022-03-25 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S034) | Boston Scientific Corp | 2022-03-24 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S809) | Medtronic Cardiac Rhythm Disease Management | 2022-03-24 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S185) | ABBOTT MEDICAL | 2022-03-24 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S776) | Medtronic Cardiac Rhythm Disease Management | 2022-03-24 |
| On X Prosthetic Heart Valve Ascending Aortic Prothesis (P000037/S059) | On-X Life Technologies, Inc. | 2022-03-24 |
| Vercise Genus DBS System (P150031/S045) | Boston Scientific Corp | 2022-03-24 |
| LCS® Total Knee System (P830055/S284) | Depuy, Inc. | 2022-03-24 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S056) | ABBOTT MEDICAL | 2022-03-24 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S710) | Medtronic, Inc. | 2022-03-24 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S076) | ABBOTT MEDICAL | 2022-03-24 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt (P130021/S111) | Medtronic, Inc. | 2022-03-24 |
| Covera Vascular Covered Stent (P170042/S011) | C.R. Bard, Inc. | 2022-03-24 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S494) | Medtronic, Inc. | 2022-03-24 |
| RX Herculink Elite Renal Stent System (P110001/S018) | Abbott Vascular | 2022-03-24 |
| HeartMate 3 Left Ventricular Assist System (P160054/S039) | ABBOTT MEDICAL | 2022-03-24 |
| NexGen LPS-Flex/ LPS-Mobile Bearing Knee System (P060037/S078) | Zimmer, Inc. | 2022-03-23 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S708) | Medtronic, Inc. | 2022-03-23 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S709) | Medtronic, Inc. | 2022-03-23 |
| 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/S774) | Medtronic Cardiac Rhythm Disease Management | 2022-03-23 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S808) | Medtronic Cardiac Rhythm Disease Management | 2022-03-23 |
| Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter (P200039/S006) | Shockwave Medical, Inc. | 2022-03-23 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S493) | Medtronic, Inc. | 2022-03-23 |
| SOLESTA Injectable Gel (P100014/S032) | Palette Life Sciences | 2022-03-22 |
| DEFLUX Injectable Gel (P000029/S094) | Palette Life Sciences | 2022-03-22 |
| Ceramax® Ceramic Total Hip System (P070026/S094) | DePuy Orthopaedics, Inc. | 2022-03-22 |
| Bausch + Lomb PureVision® (balafilcon A) Visibility Tinted Soft Contact Lenses (P980006/S034) | Bausch & Lomb, Inc. | 2022-03-21 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S016) | Bausch and Lomb, Inc., | 2022-03-21 |
| Medtronic CoreValve EnVeo R Loading System, Medtronic CoreValve EnVeo Pro Loading System, Medtronic Evolut Pro+ Loa (P130021/S112) | Medtronic, Inc. | 2022-03-21 |
| VENTANA MMR RxDx Panel (P210001/S001) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-03-21 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart OnSite Home Defibrillator (P160029/S015) | Philips Medical Systems, Inc. | 2022-03-20 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S151) | W. L. Gore & Associates, Inc. | 2022-03-18 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S417) | Medtronic, Inc. | 2022-03-18 |
| GELSYN-3 (P110005/S011) | Ibsa Institut Biochimique SA | 2022-03-18 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S034) | W. L. Gore & Associates, Inc. | 2022-03-18 |
| UroVysion Bladder Cancer Kit (P030052/S028) | Abbott Molecular | 2022-03-18 |
| SILSOFT (ELASTOFILCON A) CONTACT LENSES (P850068/S014) | Bausch & Lomb, Inc. | 2022-03-18 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S384) | Medtronic, Inc. | 2022-03-18 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S247) | Medtronic Neuromodulation | 2022-03-18 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S352) | Medtronic Neuromodulation | 2022-03-18 |
| PathVysion HER-2 DNA Probe Kit (P980024/S022) | Abbott Molecular, Inc. | 2022-03-18 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S090) | W. L. Gore & Associates, Inc. | 2022-03-18 |
| Solesta Injectable Gel (P100014/S033) | Palette Life Sciences | 2022-03-17 |
| Et Control (P210018) | Datex-Ohmeda, Inc., A General Electric Company | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| DEFLUX Injectable Gel (P000029/S095) | Palette Life Sciences | 2022-03-17 |
| InterStim Therapy System, Verify Evaluation System (P080025/S253) | Medtronic Neuromodulation | 2022-03-17 |
| DiamondTemp Radiofrequency Generator (P200028/S008) | Medtronic, Inc. | 2022-03-17 |
| InterStim Therapy System, Verify Evaluation System (P970004/S358) | Medtronic Neuromodulation | 2022-03-17 |
| InterStim® Therapy System, Verify® Evaluation System. (P080025/S238) | Medtronic Neuromodulation | 2022-03-16 |
| HeartWare Ventricular Assist (HVAD) System (P100047/S195) | Medtronic | 2022-03-16 |
| Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S125) | Medtronic Cryocath, LP | 2022-03-16 |
| Inspire Model 2580 Sleep Remote (P130008/S080) | Inspire Medical Systems | 2022-03-16 |
| FoundationOne CDx (FICDx) (P170019/S033) | Foundation Medicine, Inc. | 2022-03-16 |
| Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S050) | Abbott Diabetes Care, Inc. | 2022-03-16 |
| Master Restore, Itrel®, Synergy® and IntellisTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Sp (P840001/S501) | Medtronic Neuromodulation | 2022-03-16 |
| OPTIMIZER Smart Mini System (P180036/S009) | Impulse Dynamics (Usa), Inc. | 2022-03-16 |
| MITRIS RESILIA Mitral Valve (P150048/S047) | Edwards Lifesciences, LLC | 2022-03-16 |
| Guardant360 CDx (P200010/S005) | Guardant Health, Inc. | 2022-03-16 |
| Impella RP and Impella RP with SmartAssist (P170011/S036) | Abiomed, Inc. | 2022-03-16 |
| InterStim® Therapy System, Verify® Evaluation System. (P970004/S343) | Medtronic Neuromodulation | 2022-03-16 |
| Activa® Deep Brain Stimulation Therapy System. (P960009/S409) | Medtronic, Inc. | 2022-03-16 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S056) | Abbott Diabetes Care, Inc. | 2022-03-16 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters. (P860004/S379) | Medtronic, Inc. | 2022-03-16 |
| Adherus ET AutoSpray Dural Sealant, NUS-109 (P130014/S015) | Stryker Leibinger GmbH & Co KG | 2022-03-16 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist (P140003/S091) | Abiomed, Inc. | 2022-03-16 |
| Neuro Cochlear Implant System (P200021/S011) | Oticon Medical | 2022-03-15 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S706) | Medtronic, Inc. | 2022-03-15 |
| SmartAblate Irrigation Tubing Set (P990071/S053) | Biosense Webster, Inc. | 2022-03-15 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S112) | Biotronik, Inc. | 2022-03-15 |
| Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath (P020045/S100) | Medtronic Cryocath, LP | 2022-03-15 |
| Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit (P100010/S126) | Medtronic Cryocath, LP | 2022-03-15 |
| Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes (P950037/S235) | Biotronik, Inc. | 2022-03-15 |
| SURGICEL Fibrillar Absorbable Hemostat, SURGICEL SNoW Absorbable Hemostat (N12159/S088) | ETHICON, Inc. | 2022-03-15 |
| Heartware Ventricular Assist System (P100047/S194) | Medtronic | 2022-03-15 |
| SOFLENS 38(polymacon) Soft Contact Lens (N16895/S105) | Bausch & Lomb, Inc. | 2022-03-15 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S238) | Medtronic, Inc. | 2022-03-14 |
| Alinity m HBV (P200013/S006) | Abbott Molecular, Inc. | 2022-03-14 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S506) | Medtronic Neuromodulation | 2022-03-14 |
| SelectSecure Lead (P030036/S136) | Medtronic Cardiac Rhythm Disease Management | 2022-03-14 |
| Inspire Model 4340 Respiratory Sensing Lead (P130008/S081) | Inspire Medical Systems | 2022-03-14 |
| Attain Stability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S169) | Medtronic, Inc. | 2022-03-14 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S203) | Medtronic Cardiac Rhythm Disease Management | 2022-03-14 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO (P860003/S106) | Therakos Development Limited | 2022-03-11 |
| Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S022) | Djo Global | 2022-03-11 |
| Nucleus 24 Cochlear Implant System (P970051/S210) | Cochlear Americas | 2022-03-11 |
| Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft (P990046/S063) | Medtronic Ats Medical, Inc. | 2022-03-11 |
| Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System (P150036/S057) | Edwards Lifesciences, LLC | 2022-03-11 |
| HeartWare® HVAD System (P100047/S193) | Medtronic | 2022-03-11 |
| BRACAnalysis CDx® (P140020/S022) | Myriad Genetic Laboratories | 2022-03-11 |
| Diamondback 360 Coronary Orbital Atherectomy System (P130005/S035) | Cardiovascular Systems, Inc. | 2022-03-11 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S118) | Abbott Vascular | 2022-03-11 |
| TherOx Downstream System (P170027/S009) | Zoll Circulation, Inc. | 2022-03-10 |
| Inspire Model 2740 Programmer (P130008/S079) | Inspire Medical Systems | 2022-03-10 |
| CERAMAX Total Hip System (P070026/S093) | DePuy Orthopaedics, Inc. | 2022-03-10 |
| Open Pivot Heart Valve, Open Pivot Aortic Valved Graft (P990046/S064) | Medtronic Ats Medical, Inc. | 2022-03-10 |