| ARCHITECT HBsAg Next Qualitative/ Next Confirmatory (P210003/S001) | Abbott Laboratories | 2022-09-30 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S047) | Ventana Medical Systems, Inc. | 2022-09-30 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S191) | ABBOTT MEDICAL | 2022-09-30 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S075) | ABBOTT MEDICAL | 2022-09-30 |
| ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV (P040036/S090) | Biosense Webster, Inc. | 2022-09-30 |
| ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory (P110029/S038) | Abbott Laboratories | 2022-09-30 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S126) | Boston Scientific Corp | 2022-09-30 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S060) | Medtronic Vascular | 2022-09-29 |
| R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S027) | Smith & Nephew, Inc. | 2022-09-29 |
| Thoraflex Hybrid (P210006/S003) | Vascutek, Ltd. | 2022-09-29 |
| Resolute Integrity (P110013/S117) | Medtronic Vascular | 2022-09-29 |
| Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S025) | Djo Global | 2022-09-29 |
| Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P980006/S035) | Bausch & Lomb, Inc. | 2022-09-29 |
| Tack Endovascular System (6F) (P180034/S006) | Philips Image Guided Therapy Corporation | 2022-09-29 |
| Tack Endovascular System (4F) (P190027/S003) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2022-09-29 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S083) | Intera Oncology | 2022-09-29 |
| Optilume Urethral Drug Coated Balloon (P210020/S006) | Urotronic, Inc. | 2022-09-29 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S399) | Medtronic, Inc. | 2022-09-28 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P (P030005/S221) | Guidant Corp. | 2022-09-27 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCO (N970003/S276) | Boston Scientific Corp | 2022-09-27 |
| EMBLEM S-ICD, EMBLEM MRI S ICD (P110042/S172) | Boston Scientific Corporation | 2022-09-27 |
| FoundationOne CDx (FICDx) (P170019/S038) | Foundation Medicine, Inc. | 2022-09-27 |
| EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System (P130021/S122) | Medtronic, Inc. | 2022-09-27 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD (P150012/S130) | Boston Scientific | 2022-09-27 |
| LIFEPAK® CR2 Defibrillator (P170018/S014) | Physio-Control, Inc. | 2022-09-27 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD (P960040/S481) | Boston Scientific | 2022-09-27 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, AUTOGEN CRT-D, MOMENTUM C (P010012/S557) | Boston Scientific Corp | 2022-09-27 |
| Nucleus® 24 Cochlear Implant System (P970051/S212) | Cochlear Americas | 2022-09-26 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO (P860003/S108) | Therakos Development Limited | 2022-09-23 |
| SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System (P140031/S145) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesi (P150048/S068) | Edwards Lifesciences, LLC | 2022-09-23 |
| EDWARDS INTUITY Elite Valve System (P150036/S064) | Edwards Lifesciences, LLC | 2022-09-23 |
| InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads (P080025/S263) | Medtronic Neuromodulation | 2022-09-23 |
| InterStim® Therapy System, Verify® Evaluation System, SNS Urinary Leads (P970004/S368) | Medtronic Neuromodulation | 2022-09-23 |
| Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic (P860057/S209) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S027) | Edwards Lifesciences, LLC | 2022-09-23 |
| Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S049) | The Cooper Companies | 2022-09-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr (P140031/S144) | Edwards Lifesciences, LLC | 2022-09-23 |
| GORE® CARDIOFORM Septal Occluder (GSO) (P050006/S102) | W. L. Gore & Associates, Inc. | 2022-09-23 |
| Arctic Front Advance Pro Cardiac CryoAblation Catheters (P100010/S130) | Medtronic Cryocath, LP | 2022-09-23 |
| SynchroMed® Infusion System (P860004/S398) | Medtronic, Inc. | 2022-09-22 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S011) | CooperVision, Inc. | 2022-09-22 |
| VISTAKON® (etafilcon A) Brand Contact Lenses (N18033/S109) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2022-09-22 |
| CELLUGEL® Ophthalmic Viscosurgical Devices (P990023/S018) | Alcon Laboratories | 2022-09-22 |
| VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S127) | Vistakon, Division of Johnson & Johnson Vision Car | 2022-09-22 |
| Tula® System (P190016/S005) | Tusker Medical, Inc. | 2022-09-22 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S082) | Syncardia Systems, LLC | 2022-09-22 |
| 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/S729) | Medtronic, Inc. | 2022-09-21 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S007) | Foundation Medicine, Inc. | 2022-09-21 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S506) | Medtronic, Inc. | 2022-09-21 |
| BLAZER II XP Temperature Ablation Catheter, BLAZER PRIME XP Temperature Ablation Catheter, INTELLATIP MIFI XP Tempe (P020025/S136) | Boston Scientific | 2022-09-21 |
| AngelMed Guardian System (P150009/S008) | Avertix Medical, Inc. | 2022-09-21 |
| INTELLANAV ST Ablation Catheter, BLAZER II Temperature Ablation Catheter, BLAZER II HTD Temperature Ablation Cathete (P920047/S128) | Boston Scientific Corp | 2022-09-21 |
| FoundationOne®Liquid CDx (P200006/S002) | Foundation Medicine, Inc. | 2022-09-21 |
| BLAZER OPEN-IRRIGATED Ablation Catheter, INTELANAV OPEN-IRRIGATED Ablation Catheter, INTELLANAV MIFI OPEN-IRRIGATED A (P150005/S071) | Boston Scientific Corp | 2022-09-21 |
| FoundationOne®Liquid CDx (P190032/S006) | Foundation Medicine, Inc. | 2022-09-21 |
| R3 Delta Ceramic Acetabular System (P150030/S026) | Smith & Nephew, Inc. | 2022-09-21 |
| FoundationOne®Liquid CDx (P200016/S001) | Foundation Medicine, Inc. | 2022-09-21 |
| Oncomine Dx Target Test (P160045/S031) | Life Technologies Corporation | 2022-09-21 |
| Akreos® Posterior Chamber Intraocular Lens (IOL) (P060022/S030) | Bausch & Lomb, Inc. | 2022-09-20 |
| IC-8 Apthera Intraocular Lens (IOL) (P210005/S002) | Acu Focus, Inc. | 2022-09-20 |
| IC-8 Apthera Intraocular Lens (IOL) (P210005/S001) | Acu Focus, Inc. | 2022-09-20 |
| 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/S802) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, (P980016/S836) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism (P080011/S141) | CooperVision, Inc. | 2022-09-19 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S801) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Organ Care System (OCS®) Liver (P200031/S001) | TransMedics, Inc. | 2022-09-19 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S835) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Oncomine Dx Target Test (P160045/S037) | Life Technologies Corporation | 2022-09-19 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S728) | Medtronic, Inc. | 2022-09-16 |
| IsoMed Infusion System (P990034/S043) | Medtronic, Inc. | 2022-09-16 |
| Micra AV TPS, Micra TPS (P150033/S152) | Medtronic, Inc. | 2022-09-16 |
| SBL-3 Intraocular Lens (P200020/S001) | Lenstec, Inc. | 2022-09-16 |
| Coloplast Saline-Filled Testicular Prosthesis (Torosa) (P020003/S011) | Coloplast Corp. | 2022-09-16 |
| Master SynchroMed II Infusion System (P860004/S397) | Medtronic, Inc. | 2022-09-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S058) | Medtronic Vascular | 2022-09-15 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S730) | Medtronic, Inc. | 2022-09-15 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), (P840064/S078) | Alcon Laboratories | 2022-09-15 |
| Micra AV TPS, Micra TPS (P150033/S151) | Medtronic, Inc. | 2022-09-15 |
| Sprint Quattro Lead (P920015/S271) | Medtronic, Inc. | 2022-09-15 |
| CardioMEMS HF System (P100045/S063) | ABBOTT MEDICAL | 2022-09-15 |
| CELLUGEL OVD (P990023/S017) | Alcon Laboratories | 2022-09-15 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S245) | Medtronic, Inc. | 2022-09-15 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S139) | Biotronik, Inc. | 2022-09-15 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S059) | Alcon Research, Ltd. | 2022-09-15 |
| MiSight 1 day (omafilcon A) (P180035/S010) | CooperVision, Inc. | 2022-09-15 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S125) | Boston Scientific Corp | 2022-09-15 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S208) | Medtronic Cardiac Rhythm Disease Management | 2022-09-15 |
| CapSureFix MRI Lead (P090013/S324) | Medtronic, Inc. | 2022-09-15 |
| Pulse Generator, Permanent, Implantable (P950037/S238) | Biotronik, Inc. | 2022-09-15 |
| PASCAL Precision Transcatheter Valve Repair System (P220003) | Edwards Lifesciences, LLC | 2022-09-14 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S122) | Abbott Vascular | 2022-09-14 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S528) | Medtronic Neuromodulation | 2022-09-13 |
| VenaSeal Closure System (P140018/S034) | Medtronic Vascular, Inc. | 2022-09-13 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S058) | Alcon Research, Ltd. | 2022-09-13 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S268) | Medtronic Neuromodulation | 2022-09-13 |
| R3 Delta Ceramic Acetabular System (P150030/S025) | Smith & Nephew, Inc. | 2022-09-13 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), (P840064/S077) | Alcon Laboratories | 2022-09-13 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S373) | Medtronic Neuromodulation | 2022-09-13 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) (P020004/S191) | W. L. Gore & Associates, Inc. | 2022-09-13 |