| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S564) | Boston Scientific Corp | 2022-11-02 |
| Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead (P150012/S135) | Boston Scientific | 2022-11-02 |
| Thinline Endocardial Pacing Leads (P960004/S101) | Boston Scientific | 2022-11-02 |
| Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology (P100018/S037) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2022-11-02 |
| Ventak® P2 System (P930035/S033) | Boston Scientific | 2022-11-02 |
| Master Restore, Itrel®, Synergy®, Intellis, Vanta Spinal Cord Stimulation Systems, Pisces, Specify®, Vectris® Spinal (P840001/S525) | Medtronic Neuromodulation | 2022-11-02 |
| Simplify Cervical Artificial Disc (P200022/S009) | Nuvasive, Inc. | 2022-11-02 |
| Sweet TIP® RX Steroid Eluting Lead (P960006/S055) | Boston Scientific | 2022-11-02 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S088) | Hologic, Inc. | 2022-11-02 |
| Endotak Lead System (P910073/S170) | Boston Scientific | 2022-11-02 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S021) | Medtronic Vascular, Inc. | 2022-11-01 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl (P100021/S108) | Medtronic Vascular | 2022-11-01 |
| Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting (P160043/S062) | Medtronic Vascular | 2022-11-01 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens (P100040/S053) | Medtronic Vascular | 2022-11-01 |
| M6-C Artificial Cervical Disc (P170036/S012) | Spinal Kinetics, LLC | 2022-11-01 |
| Micra (P150033/S157) | Medtronic, Inc. | 2022-11-01 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S070) | Medtronic, Inc. | 2022-11-01 |
| Axonics Sacral Neuromodulation System (Urinary) (P180046/S061) | Boston Scientific Corporation | 2022-11-01 |
| Harmony Delivery Catheter System (P200046/S012) | Medtronic, Inc. | 2022-11-01 |
| Axonics Sacral Neuromodulation System (Bowel) (P190006/S061) | Boston Scientific Corporation | 2022-11-01 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S126) | Medtronic, Inc. | 2022-11-01 |
| Medtronic Evolut PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery Catheter System, Medtronic Evolut FX Deliv (P130021/S125) | Medtronic, Inc. | 2022-11-01 |
| Nucleus Auditory Brainstem Implant (P000015/S047) | Cochlear Americas | 2022-10-31 |
| Nucleus Cochlear Implant Systems (P970051/S211) | Cochlear Americas | 2022-10-31 |
| Nucleus Cochlear Implant Systems (P890027/S062) | Cochlear Americas | 2022-10-31 |
| Avive Automated External Defibrillator (AED) System (P210015) | Avive Solutions, Inc. | 2022-10-31 |
| HeartWare® Ventricular Assist System (P100047/S202) | Medtronic | 2022-10-31 |
| Nucleus Hybrid Cochlear Implant (P130016/S048) | Cochlear Americas | 2022-10-31 |
| Nucleus Cochlear Implant Systems (P840024/S094) | Cochlear Americas | 2022-10-31 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S080) | ABBOTT MEDICAL | 2022-10-28 |
| AcrySof Posterior Chamber Intraocular Lens (P930014/S138) | Alcon Laboratories, Inc. | 2022-10-28 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S099) | Abiomed, Inc. | 2022-10-28 |
| S-ICD GEN 2, S-ICD EMBLEM MRI (P110042/S175) | Boston Scientific Corporation | 2022-10-28 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S024) | Edwards Lifesciences, LLC | 2022-10-28 |
| Impella RP Flex with SmartAssist (P170011/S039) | Abiomed, Inc. | 2022-10-28 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P200006/S003) | Foundation Medicine, Inc. | 2022-10-28 |
| PG ESSENTIO SR SL WW, PG ESSENTIO DR SL WW, PG ESSENTIO DR EL WW, PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPO (N970003/S279) | Boston Scientific Corp | 2022-10-28 |
| EXOSEAL® Vascular Closure Device (P100013/S026) | Cordis US Corporation | 2022-10-28 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S082) | Intera Oncology | 2022-10-28 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S133) | Boston Scientific | 2022-10-28 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S054) | Boston Scientific Corp | 2022-10-28 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S194) | ABBOTT MEDICAL | 2022-10-28 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR (P010012/S562) | Boston Scientific Corp | 2022-10-28 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S486) | Boston Scientific | 2022-10-28 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S100) | Alcon Research, Ltd. | 2022-10-28 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S080) | St Jude Medical | 2022-10-28 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S224) | Guidant Corp. | 2022-10-28 |
| Impella RP Flex with SmartAssist and Impella RP with SmartAssist (P170011/S040) | Abiomed, Inc. | 2022-10-28 |
| MiniMed 770G Insulin Pump (P160017/S103) | Medtronic Minimed, Inc. | 2022-10-27 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S034) | Physio-Control, Inc. | 2022-10-27 |
| MynxGrip Vascular Closure Device and two components of Mynx Control Vascular Closure Device (VCD) (P040044/S093) | Cordis US Corporation | 2022-10-27 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S374) | Medtronic Neuromodulation | 2022-10-27 |
| TherOx Downstream Console (P170027/S010) | Zoll Circulation, Inc. | 2022-10-27 |
| Valiant Thoracic Stent Graft with Captivia delivery System (P100040/S052) | Medtronic Vascular | 2022-10-27 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S005) | Kestra Medical Technologies, Inc. | 2022-10-27 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S269) | Medtronic Neuromodulation | 2022-10-27 |
| Durasphere Injectable Bulking Agent (P980053/S019) | Carbon Medical Technologies, Inc. | 2022-10-27 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S049) | Boston Scientific Corp | 2022-10-27 |
| JJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te (P980040/S151) | Johnson & Johnson Surgical Vision, Inc. | 2022-10-27 |
| LCS® Total Knee System (P830055/S298) | Depuy, Inc. | 2022-10-27 |
| SynchroMed® Infusion System (P860004/S400) | Medtronic, Inc. | 2022-10-26 |
| Bulkamid Urethral Bulking System (P170023/S012) | Boston Scientific Corporation | 2022-10-26 |
| Saluda Medical Evoke® SCS System (P190002/S001) | Saluda Medical Pty, Ltd. | 2022-10-26 |
| Bulkamid Urethral Bulking System (P170023/S013) | Boston Scientific Corporation | 2022-10-26 |
| Belotero Balance (+) Lidocaine (P090016/S049) | Merz North America, Inc. | 2022-10-26 |
| Edwards Certitude Introducer Sheath Set (P140031/S147) | Edwards Lifesciences, LLC | 2022-10-26 |
| Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear (P080011/S149) | CooperVision, Inc. | 2022-10-26 |
| Guardant360 CDx (P200010/S009) | Guardant Health, Inc. | 2022-10-26 |
| CapSureFix Novus Lead (P930039/S246) | Medtronic, Inc. | 2022-10-25 |
| Alinity i Anti-HBc (List Number 07P84) (P080023/S038) | Abbott Laboratories | 2022-10-25 |
| CapSure Sense Lead (P830061/S209) | Medtronic Cardiac Rhythm Disease Management | 2022-10-25 |
| Sprint Quattro Lead (P920015/S272) | Medtronic, Inc. | 2022-10-25 |
| Oxford® Partial Knee System (P010014/S103) | Biomet Manufacturing Corp | 2022-10-25 |
| Restylane-L; Restylane Lyft; Restylane Silk (P040024/S127) | Q-Med AB | 2022-10-25 |
| 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/S732) | Medtronic, Inc. | 2022-10-25 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S731) | Medtronic, Inc. | 2022-10-25 |
| Assure Wearable Cardioverter Defibrillator (WCD) system (P200037/S004) | Kestra Medical Technologies, Inc. | 2022-10-25 |
| 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/S806) | Medtronic Cardiac Rhythm Disease Management | 2022-10-25 |
| 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/S840) | Medtronic Cardiac Rhythm Disease Management | 2022-10-25 |
| Alinity i Anti-HBc IgM (List Number 07P86) (P060035/S036) | Abbott Laboratories | 2022-10-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S509) | Medtronic, Inc. | 2022-10-25 |
| Edwards Commander Delivery System (P200015/S030) | Edwards Lifesciences, LLC | 2022-10-24 |
| Edwards Commander Delivery System (P140031/S148) | Edwards Lifesciences, LLC | 2022-10-24 |
| Alinity m HBV (P200013/S009) | Abbott Molecular, Inc. | 2022-10-24 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S530) | Medtronic Neuromodulation | 2022-10-21 |
| ELCA Coronary Laser Catheters (P910001/S117) | Spectranetics Corp. | 2022-10-21 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S440) | Medtronic, Inc. | 2022-10-21 |
| Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve AP360 (P990046/S065) | Medtronic Ats Medical, Inc. | 2022-10-21 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S022) | Terumo Medical Corporation | 2022-10-21 |
| 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/S804) | Medtronic Cardiac Rhythm Disease Management | 2022-10-20 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P (P010015/S508) | Medtronic, Inc. | 2022-10-20 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S140) | Biotronik, Inc. | 2022-10-20 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, Mirro MRI DR/VR ICD (P980016/S838) | Medtronic Cardiac Rhythm Disease Management | 2022-10-20 |
| Permanent Defibrillator Electrodes (P980023/S115) | Biotronik, Inc. | 2022-10-20 |
| Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes (P950037/S239) | Biotronik, Inc. | 2022-10-20 |
| EDWARDS INTUITY Elite Valve System (P150036/S065) | Edwards Lifesciences, LLC | 2022-10-19 |
| Gel-One (P080020/S049) | Seikagaku Corp. | 2022-10-19 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S210) | Edwards Lifesciences, LLC | 2022-10-19 |
| PASCAL Precision Implant System (PASCAL Implant, 10mm), PASCAL Precision Implant System (PASCAL Ace Implant, 5mm) (P220003/S001) | Edwards Lifesciences, LLC | 2022-10-19 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S069) | Edwards Lifesciences, LLC | 2022-10-19 |