| Nucleus® 24 Cochlear Implant System (P970051/S226) | Cochlear Americas | 2024-05-31 |
| Nucleus® 24 Auditory Brainstem Implant System (P000015/S054) | Cochlear Americas | 2024-05-31 |
| ORBERA Intragastric Balloon (P140008/S026) | Boston Scientific Corporation | 2024-05-31 |
| Nucleus® 22 Cochlear Implant System (P840024/S097) | Cochlear Americas | 2024-05-31 |
| TriClip G4 System (P230007/S003) | ABBOTT MEDICAL | 2024-05-31 |
| Deflux® Injectable Gel (P000029/S098) | Palette Life Sciences | 2024-05-31 |
| Protégé GPS Self-Expanding Peripheral Stent System, and Protégé RX Carotid Stent System (P060001/S041) | Medtronic Vascular, Inc. | 2024-05-31 |
| LCS Total Knee System (P830055/S323) | Depuy, Inc. | 2024-05-31 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S057) | Cochlear Americas | 2024-05-31 |
| X Series, Propaq MD (P160022/S037) | ZOLL Medical Corporation | 2024-05-30 |
| Surpass Evolve Flow Diverter System (P170024/S016) | Stryker Neurovascular | 2024-05-30 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S002) | ABBOTT MEDICAL | 2024-05-30 |
| VENASEAL CLOSURE SYSTEM (P140018/S041) | Medtronic Vascular, Inc. | 2024-05-30 |
| Epic Plus, Epic Plus Supra and Epic Max Valves in the Epic Valve Sterilization Process (P040021/S057) | ABBOTT MEDICAL | 2024-05-30 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S204) | Boston Scientific Corp | 2024-05-30 |
| VISTAKON (senoflicon A) Brand Contact Lenses (P040045/S137) | Vistakon, Division of Johnson & Johnson Vision Car | 2024-05-30 |
| Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S111) | Inspire Medical Systems | 2024-05-30 |
| Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System (P130022/S056) | Nevro Corporation | 2024-05-29 |
| Aurora EV-ICD (P220012/S027) | Medtronic, Inc. | 2024-05-29 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN C (P010012/S584) | Boston Scientific Corp | 2024-05-29 |
| Navitor TAVI System (P190023/S019) | ABBOTT MEDICAL | 2024-05-29 |
| AMS 700 Inflatable Penile Prosthesis without InhibiZone (N970012/S203) | Boston Scientific Corp | 2024-05-29 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D (N970003/S294) | Boston Scientific Corp | 2024-05-29 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S107) | Alcon Research, Ltd. | 2024-05-29 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S001) | ABBOTT MEDICAL | 2024-05-29 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone (P000053/S135) | Boston Scientific Corp | 2024-05-29 |
| U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S239) | Guidant Corp. | 2024-05-29 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, automatic implantable cardioverter, with cardiac resync (P050023/S185) | Biotronik, Inc. | 2024-05-29 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT- (P010015/S540) | Medtronic, Inc. | 2024-05-29 |
| Selenia Dimensions/3Dimensions (P080003/S010) | Hologic, Inc. | 2024-05-29 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S196) | Boston Scientific Corporation | 2024-05-29 |
| 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/S860) | Medtronic Cardiac Rhythm Disease Management | 2024-05-29 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, (P150012/S159) | Boston Scientific | 2024-05-29 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S127) | Biotronik, Inc. | 2024-05-29 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S148) | Alcon Laboratories, Inc. | 2024-05-29 |
| Defibrillator, implantable, dual-chamber (P000009/S112) | Biotronik, Inc. | 2024-05-29 |
| D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI (P960040/S501) | Boston Scientific | 2024-05-29 |
| Lumicell Direct Visualization System (DVS) (P230014/S001) | Lumicell, Inc. | 2024-05-29 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S031) | Alcon Laboratories, LLC | 2024-05-29 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirr (P980016/S894) | Medtronic Cardiac Rhythm Disease Management | 2024-05-29 |
| RHA and RHA Mepi families of dermal fillers (P170002/S039) | Teoxane S.A. | 2024-05-28 |
| QDOT MICRO Navigation Catheter (P210027/S009) | Biosense Webster, Inc. | 2024-05-27 |
| LIFEPAK 35 Monitor/Defibrillator (P160026/S049) | Physio-Control, Inc. | 2024-05-24 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S538) | Medtronic, Inc. | 2024-05-24 |
| THERMOCOOL SMARTTOUCH SF Catheter (P040036/S098) | Biosense Webster, Inc. | 2024-05-24 |
| Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S160) | CooperVision, Inc. | 2024-05-24 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S781) | Medtronic, Inc. | 2024-05-24 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S427) | Medtronic, Inc. | 2024-05-24 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S092) | Boston Scientific Corp | 2024-05-24 |
| Inoue-Balloon Catheter (P910054/S009) | Toray Industries (America), Inc. | 2024-05-24 |
| THERMOCOOL SMARTTOUCH Catheter (P030031/S136) | Biosense Webster, Inc. | 2024-05-24 |
| AMS 800 Artificial Urinary Sphincter (with InhibiZone) (P000053/S134) | Boston Scientific Corp | 2024-05-23 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S479) | Medtronic, Inc. | 2024-05-23 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S005) | Edwards Lifesciences, LLC | 2024-05-23 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S080) | Edwards Lifesciences, LLC | 2024-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P200015/S054) | Edwards Lifesciences, LLC | 2024-05-23 |
| Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN (P860057/S218) | Edwards Lifesciences, LLC | 2024-05-23 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S400) | Medtronic Neuromodulation | 2024-05-23 |
| 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, Cobalt (P010031/S857) | Medtronic Cardiac Rhythm Disease Management | 2024-05-23 |
| Belotero Balance Dermal Filler (P090016/S058) | Merz North America, Inc. | 2024-05-23 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S428) | Medtronic, Inc. | 2024-05-23 |
| 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/S891) | Medtronic Cardiac Rhythm Disease Management | 2024-05-23 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems (P140031/S162) | Edwards Lifesciences, LLC | 2024-05-23 |
| ARCHITECT AUSAB/Alinity i Anti-HBs (P050051/S060) | Abbott Laboratories, Inc. | 2024-05-23 |
| EDWARDS INTUITY Elite Valve System (P150036/S075) | Edwards Lifesciences, LLC | 2024-05-23 |
| VisuMax (P150040/S017) | Carl Zeiss Meditec, Inc. | 2024-05-23 |
| Aurora EV-ICD (P220012/S023) | Medtronic, Inc. | 2024-05-23 |
| Biofinity Sphere and Sphere XR, Biofinity Energys Asphere, Biofinity Toric, Biofinity Torie XR, Biofinity Multifoeal (P080011/S162) | CooperVision, Inc. | 2024-05-23 |
| AMS 700 Inflatable Penile Prosthesis (with InhibiZone) (N970012/S202) | Boston Scientific Corp | 2024-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S174) | Edwards Lifesciences, LLC | 2024-05-23 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S295) | Medtronic Neuromodulation | 2024-05-23 |
| ARCHITECT HBsAg Qualitative Confirmatory/ Alinity i HBsAg Qualitative II Confirmatory (P110029/S050) | Abbott Laboratories | 2024-05-23 |
| Master Restore Spinal Cord Stimulation Systems, Itrel® Spinal Cord Stimulation Systems, Synergy® Spinal Cord Stimulation (P840001/S564) | Medtronic Neuromodulation | 2024-05-23 |
| Biofinity Toric Multifocal, Biofinity Toric XR (P080011/S161) | CooperVision, Inc. | 2024-05-23 |
| Helistat/ Helitene Absorbable Collagen Hemostatic Agent (P850010/S110) | Integra LifeSciences Corporation | 2024-05-22 |
| TREO® Abdominal Stent-Graft System (P190015/S016) | Bolton Medical, Inc. | 2024-05-22 |
| QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter (P210027/S005) | Biosense Webster, Inc. | 2024-05-22 |
| Cool Point Tubing Set (P060019/S056) | Irvine Biomedical, Inc. | 2024-05-22 |
| ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S583) | Boston Scientific Corp | 2024-05-22 |
| Fortify, Fortify Assura, Ellipse (P910023/S466) | ABBOTT MEDICAL | 2024-05-22 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S023) | The Spectranetics Corp. | 2024-05-22 |
| Collastat/INSTAT Absorbable Collagen Hemostatic Agent (P810006/S107) | Integra LifeSciences Corporation | 2024-05-22 |
| RELIANCE 4-FRONT (P910073/S178) | Boston Scientific | 2024-05-22 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S421) | ABBOTT MEDICAL | 2024-05-22 |
| Clareon Vivity Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity Toric Extended Vision Hydrophobic IO (P190018/S027) | Alcon Laboratories, LLC | 2024-05-21 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S122) | Abbott Vascular, Inc. | 2024-05-20 |
| Innova Vascular Self-Expanding Stent System (P140028/S080) | Boston Scientific Corporation | 2024-05-20 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S059) | Boston Scientific Corp | 2024-05-20 |
| Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60, (P980023/S126) | Biotronik, Inc. | 2024-05-19 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 (P950037/S258) | Biotronik, Inc. | 2024-05-19 |
| Ilivia Neo 7 DR-T (P000009/S111) | Biotronik, Inc. | 2024-05-19 |
| Intica Neo 7 HF -T, Intica Neo 7 HF -T QP, BS IS4 (P050023/S184) | Biotronik, Inc. | 2024-05-19 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S158) | Biotronik, Inc. | 2024-05-19 |
| Surpass Elite Flow Diverter System (P170024/S012) | Stryker Neurovascular | 2024-05-18 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S021) | Biotronik AG | 2024-05-17 |
| FoundationOne Liquid CDx (P190032/S021) | Foundation Medicine, Inc. | 2024-05-17 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S038) | Biotronik AG | 2024-05-17 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| Inspire Patient Remote (P130008/S110) | Inspire Medical Systems | 2024-05-16 |
| Biomedics 55 Asphere (ocufilcon D), Biomedics Torie (ocufilcon D) Soft (Hydrophilic) Contact Lenses for extended wear (P890023/S051) | The Cooper Companies | 2024-05-16 |