| TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC (P980040/S154) | Johnson & Johnson Surgical Vision, Inc. | 2022-12-15 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S281) | Boston Scientific Corp | 2022-12-14 |
| Trifecta (P100029/S049) | ABBOTT MEDICAL | 2022-12-14 |
| SICD Gen 2, SICD MRI (P110042/S177) | Boston Scientific Corporation | 2022-12-14 |
| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S488) | Boston Scientific | 2022-12-14 |
| Biocor/Epic (P040021/S051) | ABBOTT MEDICAL | 2022-12-14 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S080) | ABBOTT MEDICAL | 2022-12-14 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S226) | Guidant Corp. | 2022-12-14 |
| LATITUDE Wave Communicator Model 6290 (P910077/S190) | Boston Scientific | 2022-12-14 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S565) | Boston Scientific Corp | 2022-12-14 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S136) | Boston Scientific | 2022-12-14 |
| cobas CMV (P160041/S035) | Roche Molecular Systems, Inc. | 2022-12-14 |
| Portico (P190023/S011) | ABBOTT MEDICAL | 2022-12-14 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S008) | Shockwave Medical, Inc. | 2022-12-13 |
| DiamondTemp Ablation System (P200028/S013) | Medtronic, Inc. | 2022-12-13 |
| MRI Pacemakers (P150012/S132) | Boston Scientific | 2022-12-12 |
| therascreen KRAS RGQ PCR Kit (P110027/S013) | QIAGEN GmbH | 2022-12-12 |
| Crimper (P140031/S150) | Edwards Lifesciences, LLC | 2022-12-12 |
| Mara Water Vapor Ablation System (P160047/S027) | CooperSurgical, Inc. | 2022-12-12 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S560) | Boston Scientific Corp | 2022-12-12 |
| Micra AV TPS, Micra TPS (P150033/S164) | Medtronic, Inc. | 2022-12-12 |
| RESOLUTION ctDx FIRST (P210040) | Exact Sciences Corporation | 2022-12-12 |
| Crimper (P200015/S032) | Edwards Lifesciences, LLC | 2022-12-12 |
| TECNIS Eyhance IOL with TECNIS Simplicity Delivery System, Model DIB00, TECNIS Eyhance Toric II IOLs with TECNIS Simp (P980040/S155) | Johnson & Johnson Surgical Vision, Inc. | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (N970003/S280) | Boston Scientific Corp | 2022-12-12 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S010) | Great Batch Medical | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (P030005/S225) | Guidant Corp. | 2022-12-12 |
| Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S223) | Guidant Corp. | 2022-12-12 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S174) | Boston Scientific Corporation | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (P150012/S134) | Boston Scientific | 2022-12-12 |
| Non-MRI Pacemakers (N970003/S278) | Boston Scientific Corp | 2022-12-12 |
| LIFEPAK® 15 Monitor/Defibrillator (P160026/S036) | Physio-Control, Inc. | 2022-12-12 |
| Implantable Cardioverter Defibrillator (ICD) (P960040/S484) | Boston Scientific | 2022-12-12 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S010) | MicroVention, Inc. | 2022-12-09 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S273) | Medtronic Neuromodulation | 2022-12-08 |
| LIAISON® XL MUREX HBsAg Confirmatory (P190017/S010) | DiaSorin, Inc. | 2022-12-08 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S378) | Medtronic Neuromodulation | 2022-12-08 |
| MiniMed Enlite Sensor (P120010/S142) | Medtronic, Inc. | 2022-12-08 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S444) | Medtronic, Inc. | 2022-12-08 |
| FlexAbility Ablation Catheter / FlexAbility Ablation Catheter, Sensor Enabled (SE) (P110016/S081) | ABBOTT MEDICAL | 2022-12-08 |
| MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC (P150001/S101) | Medtronic Minimed | 2022-12-08 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S403) | Medtronic, Inc. | 2022-12-08 |
| Medtronic MiniMed 670G System, GS3 Transfer to MPROC, Medtronic MiniMed 770G System, Medtronic MiniMed 780G System (P160017/S105) | Medtronic Minimed, Inc. | 2022-12-08 |
| LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S014) | DiaSorin, Inc. | 2022-12-08 |
| CERAMAX Ceramic Total Hip System (P070026/S103) | DePuy Orthopaedics, Inc. | 2022-12-08 |
| Exablate 4000 System Type-1 (i.e. Type 1.0/1.1) (P150038/S022) | Insightec | 2022-12-08 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S013) | DiaSorin, Inc. | 2022-12-08 |
| Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord Stim (P840001/S534) | Medtronic Neuromodulation | 2022-12-08 |
| Safire Ablation Catheter (P040042/S054) | Irvine Biomedical,Inc.(Ibi) | 2022-12-08 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S011) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S011) | DiaSorin, Inc. | 2022-12-08 |
| Guardian Connect System (P160007/S046) | Medtronic Minimed | 2022-12-08 |
| Livewire TC Ablation Catheter (P960016/S089) | St Jude Medical | 2022-12-08 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S011) | DiaSorin, Inc. | 2022-12-08 |
| LIAISON® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus (P180047/S022) | DiaSorin, Inc. | 2022-12-08 |
| TactiCath Ablation Catheter, Sensor Enabled (SE) (P130026/S081) | St Jude Medical | 2022-12-08 |
| Pulse Generator, Permanent, Implantable (P950037/S241) | Biotronik, Inc. | 2022-12-07 |
| BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear (P080011/S151) | CooperVision, Inc. | 2022-12-07 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S142) | Biotronik, Inc. | 2022-12-07 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S132) | Boston Scientific Corp | 2022-12-07 |
| Cordis® PRECISE® Nitinol Stent System (P030047/S045) | Cordis US Corporation | 2022-12-07 |
| INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S103) | Integra Lifesciences Corp. | 2022-12-07 |
| Artic Front Advance Cardiac Cryoablation Catheter, Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S133) | Medtronic Cryocath, LP | 2022-12-07 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S168) | Biotronik, Inc. | 2022-12-07 |
| ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory (P110029/S040) | Abbott Laboratories | 2022-12-07 |
| Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System (P120002/S022) | Cordis US Corporation | 2022-12-07 |
| Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System (P020036/S047) | Cordis US Corporation | 2022-12-07 |
| ARCHITECT AUSAB/Alinity i Anti-HBs (P050051/S048) | Abbott Laboratories, Inc. | 2022-12-07 |
| IsoFlex (P960030/S077) | ABBOTT MEDICAL | 2022-12-07 |
| Assurity MRI, Endurity MRI (P140033/S076) | ABBOTT MEDICAL | 2022-12-07 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S176) | Boston Scientific Corporation | 2022-12-07 |
| BD Onclarity HPV Assay (P160037/S013) | Becton, Dickinson and Company | 2022-12-07 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S116) | Biotronik, Inc. | 2022-12-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S004) | Edwards Lifesciences, LLC | 2022-12-07 |
| LCS® Total Knee System (P830055/S264) | Depuy, Inc. | 2022-12-07 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory (P210003/S003) | Abbott Laboratories | 2022-12-07 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S012) | CooperVision, Inc. | 2022-12-07 |
| Defibrillator, implantable, dual-chamber (P000009/S099) | Biotronik, Inc. | 2022-12-07 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S089) | Boston Scientific Corp | 2022-12-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S003) | Edwards Lifesciences, LLC | 2022-12-07 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S002) | Endomagnetics Ltd., | 2022-12-06 |
| Nucleus 24 Auditory Brainstem Implant System (P000015/S048) | Cochlear Americas | 2022-12-06 |
| Trifecta Valve with Glide Technology (P100029/S048) | ABBOTT MEDICAL | 2022-12-06 |
| Nucleus Hybrid L24 Cochlear Implant System (P130016/S051) | Cochlear Americas | 2022-12-06 |
| AFX2 Endovascular AAA System (P040002/S070) | Endologix, LLC | 2022-12-06 |
| Nucleus 24 Cochlear Implant System (P970051/S214) | Cochlear Americas | 2022-12-06 |
| Nucleus 22 Cochlear Implant System (P890027/S061) | Cochlear Americas | 2022-12-06 |
| TECNIS® CL Foldable Silicone Posterior Chamber IOL (P880081/S047) | Johnson & Johnson Surgical Vision, Inc. | 2022-12-06 |
| Nucleus® 24 Cochlear Implant System (P970051/S215) | Cochlear Americas | 2022-12-06 |
| Nucleus 22 Cochlear Implant System (P840024/S093) | Cochlear Americas | 2022-12-06 |
| SENSAR® 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS Monofocal 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (P980040/S153) | Johnson & Johnson Surgical Vision, Inc. | 2022-12-06 |
| TECNIS® Multifocal Foldable Posterior Chamber IOL (P080010/S021) | Johnson & Johnson Surgical Vision, Inc. | 2022-12-06 |
| TECNIS® Foldable Acrylic IOL (P990080/S056) | Johnson & Johnson Surgical Vision, Inc. | 2022-12-06 |
| Impella RP, Impella RP with SmartAssist (P170011/S047) | Abiomed, Inc. | 2022-12-05 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S402) | Medtronic, Inc. | 2022-12-02 |
| TheraSphere (P200029/S004) | Boston Scientific Corporation | 2022-12-02 |
| OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO (P180036/S013) | Impulse Dynamics (Usa), Inc. | 2022-12-02 |
| DataBridge 4G/LTE Adapter (P950037/S240) | Biotronik, Inc. | 2022-12-02 |
| IC-8 Apthera Intraocular Lens (IOL) (P210005/S004) | Acu Focus, Inc. | 2022-12-02 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S128) | Medtronic, Inc. | 2022-12-01 |