| Myocardial Pacing Lead (P120017/S031) | Medtronic, Inc. | 2022-06-01 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S138) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT (P110015/S010) | Advanced Breath Diagnostics | 2022-06-01 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S162) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S501) | Medtronic, Inc. | 2022-06-01 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S393) | Medtronic, Inc. | 2022-06-01 |
| Transvene CS/SVC Lead (P980050/S138) | Medtronic, Inc. | 2022-06-01 |
| CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S (P890003/S454) | Medtronic, Inc. | 2022-06-01 |
| LifeVest Wearable Defibrillator (P010030/S159) | Zoll Manufacturing Corporation | 2022-06-01 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S431) | Medtronic, Inc. | 2022-06-01 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) (P970004/S366) | Medtronic Neuromodulation | 2022-06-01 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S172) | Medtronic, Inc. | 2022-06-01 |
| ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S169) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) (P080025/S261) | Medtronic Neuromodulation | 2022-06-01 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S243) | Medtronic, Inc. | 2022-06-01 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S823) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| InterStim Therapy System SNS Urinary Neurostimulator (P970004/S363) | Medtronic Neuromodulation | 2022-06-01 |
| Adapta, Versa, Sensia IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta DR/SR MRI IPG, Azure S DR/SR MRI IPG, (P980035/S719) | Medtronic, Inc. | 2022-06-01 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens (P170035/S017) | Bausch and Lomb, Inc., | 2022-06-01 |
| CapSure Epicardial Pacing Lead (P950024/S104) | Medtronic, Inc. | 2022-06-01 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S207) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| 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/S718) | Medtronic, Inc. | 2022-06-01 |
| InterStim Therapy System SNS Bowel Neurostimulator (P080025/S258) | Medtronic Neuromodulation | 2022-06-01 |
| RF Conductr, RF Enhancr II, RF Marinr, RF Unipolar Marinr (P930029/S071) | Medtronic, Inc. | 2022-06-01 |
| 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, Cobalt (P010031/S790) | Medtronic Cardiac Rhythm Disease Management | 2022-06-01 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S520) | Medtronic Neuromodulation | 2022-06-01 |
| Cerene Cryotherapy Device (P180032/S010) | Channel Medsystems, Inc. | 2022-05-31 |
| HeartSine samaritan® Public Access Automated External Defibrillators and Accessories (P160008/S019) | Heartsine Technologies, Ltd. | 2022-05-31 |
| OrganOx metra® System (P200035/S002) | Organox Limited | 2022-05-27 |
| Restylane Refyne, Restylane Defyne and Restylane Kysse (injectable gels) (P140029/S033) | Q-Med AB | 2022-05-27 |
| Neuro Cochlear Implant System (NCIS) (P200021/S012) | Oticon Medical | 2022-05-27 |
| AED Plus (P160015/S014) | ZOLL Medical Corporation | 2022-05-27 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev (P980016/S820) | Medtronic Cardiac Rhythm Disease Management | 2022-05-26 |
| GORE VIABAHN Endoprosthesis (P040037/S152) | W. L. Gore & Associates, Inc. | 2022-05-26 |
| Alinity m CMV (P210022/S001) | Abbott Molecular, Inc. | 2022-05-26 |
| Saluda Medical Evoke SCS System (P190002/S008) | Saluda Medical Pty, Ltd. | 2022-05-26 |
| Genesys HTA System (P000040/S042) | Axora Medical, Inc. | 2022-05-26 |
| Bard E- Luminexx Vascular Stent System (P080007/S027) | Bard Peripheral Vascular, Inc. | 2022-05-26 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S091) | W. L. Gore & Associates, Inc. | 2022-05-26 |
| 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, Cobalt (P010031/S787) | Medtronic Cardiac Rhythm Disease Management | 2022-05-26 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S821) | Medtronic Cardiac Rhythm Disease Management | 2022-05-25 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S429) | Medtronic, Inc. | 2022-05-25 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chro (P150003/S086) | Boston Scientific Corporation | 2022-05-25 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S788) | Medtronic Cardiac Rhythm Disease Management | 2022-05-25 |
| Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulat (P840001/S518) | Medtronic Neuromodulation | 2022-05-25 |
| Surgicel Nu-Knit Absorbable Hemostat (N12159/S092) | ETHICON, Inc. | 2022-05-25 |
| FoundationOne Liquid CDx (P190032/S003) | Foundation Medicine, Inc. | 2022-05-25 |
| BioGlue Surgical Adhesive (P010003/S040) | Cryolife, Inc. | 2022-05-25 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS (P860003/S107) | Therakos Development Limited | 2022-05-25 |
| Tack Endovascular System (4F) (P190027/S004) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2022-05-24 |
| Eversense E3 Continuous Glucose Monitoring System (P160048/S019) | Senseonics, Incorporated | 2022-05-24 |
| Biomedics 55 Asphere (P890023/S048) | The Cooper Companies | 2022-05-24 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S428) | Medtronic, Inc. | 2022-05-24 |
| Tack Endovascular System (6F) (P180034/S007) | Philips Image Guided Therapy Corporation | 2022-05-24 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S427) | Medtronic, Inc. | 2022-05-24 |
| Master Vanta Spinal Cord Stimulation Systems (P840001/S517) | Medtronic Neuromodulation | 2022-05-24 |
| Harmony Transcatheter Pulmonary Valve (P200046/S009) | Medtronic, Inc. | 2022-05-23 |
| Venovo Venous Stent System (P180037/S011) | Bard Peripheral Vascular, Inc. | 2022-05-23 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt (P130021/S116) | Medtronic, Inc. | 2022-05-23 |
| Protege RX Carotid Stent System (P060001/S033) | Medtronic Vascular, Inc. | 2022-05-23 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S099) | Integra LifeSciences Corporation | 2022-05-20 |
| Integra® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S100) | Integra Lifesciences Corp. | 2022-05-20 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal (P990009/S069) | Baxter Healthcare Corp | 2022-05-20 |
| NexGen LPS-Flex/ LPS-Mobile Bearing Knee (P060037/S079) | Zimmer, Inc. | 2022-05-20 |
| EVO/EVO+ VISIAN® Implantable Collamer® Lenses (P030016/S042) | STAAR Surgical Company | 2022-05-20 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S822) | Medtronic Cardiac Rhythm Disease Management | 2022-05-20 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S789) | Medtronic Cardiac Rhythm Disease Management | 2022-05-20 |
| Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S102) | Integra LifeSciences Corporation | 2022-05-20 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S080) | Intera Oncology | 2022-05-20 |
| VENTANA MMR RxDx Panel (P210001/S005) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-05-20 |
| CollaCote, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S085) | Integra Lifesciences Corp. | 2022-05-20 |
| Pulsar-18 Stent Systems (P160025/S014) | Biotronik AG | 2022-05-20 |
| Venovo Venous Stent System (P180037/S010) | Bard Peripheral Vascular, Inc. | 2022-05-20 |
| Birmingham Hip Resurfacing (BHR) System (P040033/S036) | Smith & Nephew, Inc. | 2022-05-19 |
| WOLVERINE Coronary Cutting Balloon (P950020/S121) | Boston Scientific Corp | 2022-05-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cono (P150003/S087) | Boston Scientific Corporation | 2022-05-19 |
| AngelMed Guardian System (P150009/S007) | Avertix Medical, Inc. | 2022-05-19 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S048) | Boston Scientific Corp | 2022-05-19 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S169) | Boston Scientific Corporation | 2022-05-18 |
| JJSVs intraocular lenses (IOLs) (P980040/S147) | Johnson & Johnson Surgical Vision, Inc. | 2022-05-18 |
| HeartWare Ventricular Assist System (P100047/S184) | Medtronic | 2022-05-18 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S103) | Alcon Research, Ltd. | 2022-05-18 |
| MED-EL CONCERT (PIN) Cochlear Implant (P000025/S123) | Med-El Corp. | 2022-05-18 |
| Guardant360 CDx (P200010/S004) | Guardant Health, Inc. | 2022-05-18 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S020) | Alcon Laboratories, LLC | 2022-05-18 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S143) | Alcon Laboratories, Inc. | 2022-05-18 |
| SURGICEL® Absorbable Hemostats (SURGICEL® FIBRILLAR, SURGICEL® SNOW) (N12159/S089) | ETHICON, Inc. | 2022-05-18 |
| Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avant VR, Avant DR (P910023/S444) | ABBOTT MEDICAL | 2022-05-18 |
| R3 Delta Ceramic Hip System, Reflection Ceramic Hip System (P150030/S021) | Smith & Nephew, Inc. | 2022-05-17 |
| Microny family of Pacemakers (P970013/S090) | ABBOTT MEDICAL | 2022-05-17 |
| 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, Cobalt (P010031/S786) | Medtronic Cardiac Rhythm Disease Management | 2022-05-17 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S717) | Medtronic, Inc. | 2022-05-17 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S499) | Medtronic, Inc. | 2022-05-17 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S443) | ABBOTT MEDICAL | 2022-05-17 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S323) | ABBOTT MEDICAL | 2022-05-17 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S072) | ABBOTT MEDICAL | 2022-05-17 |
| Optilume Urethral Drug Coated Balloon (P210020/S004) | Urotronic, Inc. | 2022-05-17 |
| Micra AV TPS and Micra TPS (P150033/S140) | Medtronic, Inc. | 2022-05-17 |
| MAESTRO System Software 9.0 (P000025/S124) | Med-El Corp. | 2022-05-17 |
| Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene (P900033/S098) | Integra Lifesciences Corp. | 2022-05-17 |