| RF Conductr, RF Contactr, RF Enhancr II, RF Marinr, RF Unipolar Marinr (P930029/S070) | Medtronic, Inc. | 2021-12-07 |
| 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/S696) | Medtronic, Inc. | 2021-12-07 |
| 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/S798) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Nucleus® 24 Cochlear Implant System (P970051/S206) | Cochlear Americas | 2021-12-07 |
| CapSureFix MRI Lead (P090013/S317) | Medtronic, Inc. | 2021-12-07 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S165) | Medtronic, Inc. | 2021-12-07 |
| 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/S764) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Attain StarFix Lead (P060039/S109) | Medtronic, Inc. | 2021-12-07 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S133) | Medtronic Cardiac Rhythm Disease Management | 2021-12-07 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S261) | Medtronic, Inc. | 2021-12-07 |
| Nucleus® Auditory Brainstem Implant System (P000015/S046) | Cochlear Americas | 2021-12-07 |
| Micra AV TPS, Micra TPS (P150033/S127) | Medtronic, Inc. | 2021-12-07 |
| Myocardial Pacing Lead (P120017/S029) | Medtronic, Inc. | 2021-12-07 |
| Transvene CS/SVC Lead (P980050/S136) | Medtronic, Inc. | 2021-12-07 |
| CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S (P890003/S450) | Medtronic, Inc. | 2021-12-07 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S234) | Medtronic, Inc. | 2021-12-07 |
| 4Kscore Test (P190022) | Opko Health, Inc. | 2021-12-07 |
| ARCHITECT Free PSA (LN 6C07) (P980007/S045) | Abbott Laboratories | 2021-12-06 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S044) | Abbott Laboratories, Inc. | 2021-12-06 |
| ARCHITECT CORE (LN 6L22) (P080023/S035) | Abbott Laboratories | 2021-12-06 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S114) | Boston Scientific Corp | 2021-12-06 |
| ARCHITECT CORE-M (LN 6L23) (P060035/S033) | Abbott Laboratories | 2021-12-06 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S115) | Boston Scientific Corp | 2021-12-06 |
| ARCHITECT AFP (LN 3P36) (P120008/S018) | Abbott Laboratories | 2021-12-06 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S078) | Intera Oncology | 2021-12-06 |
| ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54) (P110029/S035) | Abbott Laboratories | 2021-12-06 |
| ARCHITECT Anti-HCV (LN 1L79) (P050042/S046) | Abbott Laboratories, Inc. | 2021-12-06 |
| ARCHITECT Total PSA (LN 6C06) (P910007/S056) | Abbott Laboratories | 2021-12-06 |
| Master Restore, Itrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Yectris Spin (P840001/S503) | Medtronic Neuromodulation | 2021-12-03 |
| GORE® VIABAHN® Endoprosthesis (P040037/S149) | W. L. Gore & Associates, Inc. | 2021-12-03 |
| InterStim Therapy System, Verify Evaluation System (P970004/S346) | Medtronic Neuromodulation | 2021-12-03 |
| LifeVest® Wearable Defibrillator (P010030/S156) | Zoll Manufacturing Corporation | 2021-12-03 |
| Optilume Urethral Drug Coated Balloon (P210020) | Urotronic, Inc. | 2021-12-03 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S076) | Alcon Laboratories | 2021-12-03 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S088) | W. L. Gore & Associates, Inc. | 2021-12-03 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S413) | Medtronic, Inc. | 2021-12-03 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S382) | Medtronic, Inc. | 2021-12-03 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S075) | Alcon Laboratories | 2021-12-03 |
| InterStim Therapy System, Verify Evaluation System (P080025/S241) | Medtronic Neuromodulation | 2021-12-03 |
| Lutonix 035 (P130024/S042) | Lutonix | 2021-12-02 |
| Single-Piece PMMA Anterior Chamber IOLs (P880087/S031) | Alcon Laboratories | 2021-12-02 |
| Lutonix 018 (P170003/S025) | Lutonix | 2021-12-02 |
| Single-Piece PMMA Posterior Chamber IOL (P840060/S049) | Alcon Laboratories | 2021-12-02 |
| ADATO Sil-Ol 5000 Silicone Oil (P910071/S018) | Bausch & Lomb | 2021-12-02 |
| TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOL (P980040/S140) | Johnson & Johnson Surgical Vision, Inc. | 2021-12-01 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S347) | Medtronic Neuromodulation | 2021-12-01 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S242) | Medtronic Neuromodulation | 2021-12-01 |
| Medtronic CoreValve EnVeo R Delivery Catheter System, Medtronic CoreValve EnVeo Pro Delivery Catheter System, Medtro (P130021/S106) | Medtronic, Inc. | 2021-12-01 |
| Oncomine Dx Target Test (P160045/S027) | Life Technologies Corporation | 2021-12-01 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S014) | Alcon Laboratories, LLC | 2021-12-01 |
| Optisure (P950022/S142) | ABBOTT MEDICAL | 2021-12-01 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S695) | Medtronic, Inc. | 2021-11-30 |
| Subcutaneous ICD Devices (P110042/S159) | Boston Scientific Corporation | 2021-11-30 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S116) | Boston Scientific | 2021-11-30 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S267) | Boston Scientific Corp | 2021-11-30 |
| 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, E (P980016/S797) | Medtronic Cardiac Rhythm Disease Management | 2021-11-30 |
| Hydrus® Microstent (P170034/S007) | Alcon Research, LLC | 2021-11-30 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S485) | Medtronic, Inc. | 2021-11-30 |
| LATITUDE Programming System (P910077/S186) | Boston Scientific | 2021-11-30 |
| 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/S763) | Medtronic Cardiac Rhythm Disease Management | 2021-11-30 |
| Restylane Contour (P140029/S043) | Q-Med AB | 2021-11-30 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S212) | Guidant Corp. | 2021-11-30 |
| Surpass Evolve Flow Diverter System (P170024/S011) | Stryker Neurovascular | 2021-11-30 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S468) | Boston Scientific | 2021-11-30 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S543) | Boston Scientific Corp | 2021-11-30 |
| QUIK-PAK Electrodes (P160012/S002) | Physio-Control, Inc. | 2021-11-29 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S096) | W. L. Gore & Associates, Inc. | 2021-11-29 |
| Alair Bronchial Thermoplasty System (P080032/S020) | Boston Scientific Corp | 2021-11-26 |
| Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System (P900056/S195) | Boston Scientific Corp | 2021-11-26 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S166) | Medtronic, Inc. | 2021-11-24 |
| XACT Carotid Stent System (P040038/S038) | Abbott Vascular, Inc. | 2021-11-24 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System (P160043/S056) | Medtronic Vascular | 2021-11-24 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S235) | Medtronic, Inc. | 2021-11-24 |
| SelectSecure Lead (P030036/S134) | Medtronic Cardiac Rhythm Disease Management | 2021-11-24 |
| HeartMate II Left Ventricular Assist System (P060040/S081) | ABBOTT MEDICAL | 2021-11-24 |
| Sprint Quattro Lead (P920015/S262) | Medtronic, Inc. | 2021-11-24 |
| CapSureFix MRI Lead (P090013/S318) | Medtronic, Inc. | 2021-11-24 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S201) | Medtronic Cardiac Rhythm Disease Management | 2021-11-24 |
| Micra AV TPS, Micra TPS (P150033/S128) | Medtronic, Inc. | 2021-11-24 |
| HeartMate 3 Left Ventricular Assist System (P160054/S040) | ABBOTT MEDICAL | 2021-11-24 |
| CardioMEMS HF System (P100045/S052) | ABBOTT MEDICAL | 2021-11-23 |
| HeartWare® Ventricular Assist System or HeartWare® System (P100047/S191) | Medtronic | 2021-11-23 |
| BD FocalPoint GS Imaging System (P950009/S025) | Bd Diagnostics | 2021-11-23 |
| Sculptra and Sculptra Aesthetic (P030050/S034) | Q-Med AB | 2021-11-23 |
| Fluency® Plus Endovascular Stent Graft (P130029/S011) | Bard Peripheral Vascular, Inc. | 2021-11-23 |
| Perfluoron (P950018/S020) | Alcon Laboratories | 2021-11-23 |
| PD-L1 IHC 22C3 pharmDx (P150013/S023) | Agilent Technologies, Inc. | 2021-11-23 |
| E-Luminexx® Vascular Stent (P080007/S026) | Bard Peripheral Vascular, Inc. | 2021-11-23 |
| Impella CP with SmartAssist (P140003/S085) | Abiomed, Inc. | 2021-11-22 |
| HeartWare Ventricular Assist System (P100047/S183) | Medtronic | 2021-11-22 |
| Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System (P140003/S089) | Abiomed, Inc. | 2021-11-22 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S005) | W. L. Gore and Associates, Inc. | 2021-11-22 |
| Axonics Sacral Neuromodulation System (P180046/S043) | Boston Scientific Corporation | 2021-11-22 |
| Impella RP (P170011/S034) | Abiomed, Inc. | 2021-11-22 |
| Micra AV TPS, Micra TPS (P150033/S126) | Medtronic, Inc. | 2021-11-22 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S084) | Abiomed, Inc. | 2021-11-22 |
| Axonics Sacral Neuromodulation System (P190006/S043) | Boston Scientific Corporation | 2021-11-22 |
| LCS Total Knee System (P830055/S273) | Depuy, Inc. | 2021-11-20 |
| Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S044) | Abbott Diabetes Care, Inc. | 2021-11-19 |
| WaveLight EX500 Laser System (P020050/S039) | Alcon Laboratories, Inc. | 2021-11-19 |