| On- X Prosthetic Heart Valve, Ascending Aortic Prothesis (P000037/S060) | On-X Life Technologies, Inc. | 2022-08-01 |
| Juvéderm Volux XC (P110033/S065) | Allergan | 2022-07-29 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S037) | Ventana Medical Systems, Inc. | 2022-07-29 |
| Exablate Model 4000 Type 1.0 and 1.1 Systems (P150038/S018) | Insightec | 2022-07-29 |
| CINtec PLUS Cytology (P190024/S007) | Ventana Medical Systems, Inc. | 2022-07-29 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S005) | Ventana Medical Systems, Inc. | 2022-07-29 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S018) | Ventana Medical Systems, Inc. | 2022-07-29 |
| Guardant360® CDx (P200010/S011) | Guardant Health, Inc. | 2022-07-29 |
| VENTANA PD-L1 (SP142) Assay (P160002/S018) | Ventana Medical Systems, Inc. | 2022-07-29 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S027) | Ventana Medical Systems, Inc. | 2022-07-29 |
| VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) (P210001/S006) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-07-29 |
| VENTANA PD-L1 (SP263) Assay (P160046/S014) | Ventana Medical Systems, Inc. | 2022-07-29 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S005) | Ventana Medical Systems | 2022-07-29 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S051) | Boston Scientific Corp | 2022-07-29 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S048) | Ventana Medical Systems, Inc. | 2022-07-29 |
| Orchestra, Orchestra Plus, and SmartTouch programming software modules (P980049/S143) | MicroPort CRM USA, Inc. | 2022-07-28 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S394) | Medtronic, Inc. | 2022-07-28 |
| GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) (P020004/S189) | W. L. Gore & Associates, Inc. | 2022-07-28 |
| Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve (P150011/S025) | Corcym S.r.l. | 2022-07-28 |
| Solo Smart Heart Valve (P130011/S011) | Corcym Canada Corp | 2022-07-28 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S435) | Medtronic, Inc. | 2022-07-28 |
| LIFEPAK Automated External Defibrillator (AED) (P160026/S031) | Physio-Control, Inc. | 2022-07-28 |
| Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm (P030004/S029) | Ev3 Neurovascular | 2022-07-28 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S141) | Edwards Lifesciences, LLC | 2022-07-28 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S004) | ABBOTT MEDICAL | 2022-07-28 |
| Fineline II Sterox, Sterox EZ pace / sense leads (P960004/S100) | Boston Scientific | 2022-07-28 |
| NeuroPace RNS System (P100026/S090) | NeuroPace, Inc. | 2022-07-28 |
| LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK® 20e Defibrillator/Monitor (P160026/S032) | Physio-Control, Inc. | 2022-07-28 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S371) | Medtronic Neuromodulation | 2022-07-28 |
| Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO (P170013/S004) | MicroVention, Inc. | 2022-07-28 |
| Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord S (P840001/S522) | Medtronic Neuromodulation | 2022-07-28 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S266) | Medtronic Neuromodulation | 2022-07-28 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S015) | Biotronik AG | 2022-07-27 |
| PG Essentio SR SL, PG Essentio DR SL, PG Essentio DR EL, PG Proponent SR SL, PG Proponent DR SL, PD Proponent DR EL, PG (N970003/S274) | Boston Scientific Corp | 2022-07-27 |
| HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507 (P160029/S017) | Philips Medical Systems, Inc. | 2022-07-27 |
| Harmony Transcatheter Pulmonary Valve (P200046/S011) | Medtronic, Inc. | 2022-07-27 |
| Micra AV TPS, Micra TPS (P150033/S148) | Medtronic, Inc. | 2022-07-27 |
| ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) (P210019) | Siemens Healthcare Diagnostics, Inc. | 2022-07-27 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S008) | W. L. Gore and Associates, Inc. | 2022-07-27 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S015) | Biotronik AG | 2022-07-27 |
| PG Essentio MRI SR SL, PG Essentio MRI DR SL, PG Essentio MRI DR EL, PG Proponent MRI SR SL, PG Proponent MRI DR EL, PG (P150012/S127) | Boston Scientific | 2022-07-27 |
| PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C (P030005/S219) | Guidant Corp. | 2022-07-27 |
| VenaSeal Closure System (P140018/S032) | Medtronic Vascular, Inc. | 2022-07-27 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S024) | Biotronik AG | 2022-07-27 |
| Astron Pulsar Stent System, Pulsar-18 Stent System (P160025/S015) | Biotronik AG | 2022-07-27 |
| SURGICEL Original Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, (N12159/S086) | ETHICON, Inc. | 2022-07-26 |
| Micra AV TPS, Micra TPS (P150033/S147) | Medtronic, Inc. | 2022-07-26 |
| Saluda Medical Evoke SCS System (P190002/S009) | Saluda Medical Pty, Ltd. | 2022-07-26 |
| 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/S829) | Medtronic Cardiac Rhythm Disease Management | 2022-07-25 |
| 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/S724) | Medtronic, Inc. | 2022-07-25 |
| CERAMAX Ceramic Total Hip System (P070026/S095) | DePuy Orthopaedics, Inc. | 2022-07-25 |
| 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/S795) | Medtronic Cardiac Rhythm Disease Management | 2022-07-25 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S023) | Edwards Lifesciences, LLC | 2022-07-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S503) | Medtronic, Inc. | 2022-07-25 |
| Ingevity MRI pace/sense lead, Ingevity+ MRI pace/sense lead (P150012/S128) | Boston Scientific | 2022-07-25 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S146) | CooperVision, Inc. | 2022-07-25 |
| TECNIS® Symfony, TECNIS® Symfony Toric, TECNIS® Symfony OptiBlue®, TECNIS® Symfony OptiBlue® with TECNIS Simplicity® (P980040/S149) | Johnson & Johnson Surgical Vision, Inc. | 2022-07-25 |
| Micra AV TPS, Micra TPS (P150033/S146) | Medtronic, Inc. | 2022-07-25 |
| Sculptra and Sculptra Aesthetic (P030050/S035) | Q-Med AB | 2022-07-25 |
| LCS(R) Total Knee System (P830055/S286) | Depuy, Inc. | 2022-07-25 |
| Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-D, ICD Dynagen CRT-D, Vigilant CRT-D, Vigilant X4 CRT-D, Resonate CRT- (P010012/S556) | Boston Scientific Corp | 2022-07-22 |
| IC-8 Apthera Intraocular Lens (IOL) (P210005) | Acu Focus, Inc. | 2022-07-22 |
| SBL-3 Multifocal Intraocular Lens (P200020) | Lenstec, Inc. | 2022-07-22 |
| Gel-One (P080020/S048) | Seikagaku Corp. | 2022-07-22 |
| Artisan Myopia (P030028/S009) | Ophtec BV | 2022-07-22 |
| Model 3100A/B High Frequency Oscillatory Ventilator (P890057/S025) | ZOLL Medical Corporation | 2022-07-22 |
| ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I (P960040/S480) | Boston Scientific | 2022-07-22 |
| PD-L1 IHC 28-8 pharmDx (P150025/S015) | Agilent Technologies, Inc. | 2022-07-22 |
| Abre Venous Self-expanding Stent System (P200026/S005) | Medtronic Vascular, Inc. | 2022-07-22 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S004) | Ventana Medical Systems, Inc. | 2022-07-21 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S002) | W. L. Gore & Associates, Inc. | 2022-07-21 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S017) | Ventana Medical Systems, Inc. | 2022-07-21 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S036) | Ventana Medical Systems, Inc. | 2022-07-21 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S046) | Ventana Medical Systems, Inc. | 2022-07-21 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S004) | Ventana Medical Systems | 2022-07-21 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S026) | Ventana Medical Systems, Inc. | 2022-07-21 |
| RingJect and Capsular Tension Ring (CTR) (P030023/S008) | Ophtec BV | 2022-07-21 |
| VENTANA MMR RxDx Panel Solid Tumors with dMMR status) (P210001/S004) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-07-21 |
| VENTANA PD-Ll (SP263) Assay (P160046/S012) | Ventana Medical Systems, Inc. | 2022-07-21 |
| Master Restore, Itrel, Synergy and lntellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S514) | Medtronic Neuromodulation | 2022-07-21 |
| CINtec PLUS Cytology (P190024/S006) | Ventana Medical Systems, Inc. | 2022-07-21 |
| VENTANA PD-Ll (SP142) Assay (P160002/S017) | Ventana Medical Systems, Inc. | 2022-07-21 |
| Pulsar-18 T3 Stent System (P160025/S013) | Biotronik AG | 2022-07-20 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S824) | Medtronic Cardiac Rhythm Disease Management | 2022-07-20 |
| ENROUTE Transcarotid Stent System (P140026/S020) | Boston Scientific Corporation | 2022-07-20 |
| Restylane Injectable Gels (P040024/S131) | Q-Med AB | 2022-07-20 |
| CareLink SmartSync Cobalt/Crome App, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S791) | Medtronic Cardiac Rhythm Disease Management | 2022-07-20 |
| QUIK-PAK Electrodes (P160012/S006) | Physio-Control, Inc. | 2022-07-20 |
| Axonics Sacral Neuromodulation System (P180046/S057) | Boston Scientific Corporation | 2022-07-20 |
| Sientra OPUS® Silicone Gel Breast Implants (P070004/S037) | Tiger Aesthetics Medical, LLC | 2022-07-20 |
| Aptima HBV Quant Assay (P170025/S018) | Hologic, Inc. | 2022-07-20 |
| Aptima CMV Quant Assay (P210029/S001) | Hologic, Inc. | 2022-07-20 |
| Axonics Sacral Neuromodulation System (P190006/S057) | Boston Scientific Corporation | 2022-07-20 |
| Transcend® Hip Articulation System (P010001/S025) | Ceramtec GmbH | 2022-07-20 |
| TECNIS Eyhance Toric II, Model ICU, TECNIS Eyhance Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy T (P980040/S148) | Johnson & Johnson Surgical Vision, Inc. | 2022-07-20 |
| 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/S793) | Medtronic Cardiac Rhythm Disease Management | 2022-07-19 |
| 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/S827) | Medtronic Cardiac Rhythm Disease Management | 2022-07-19 |
| 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/S722) | Medtronic, Inc. | 2022-07-19 |
| Cologuard® (P130017/S053) | Exact Sciences Corporation | 2022-07-19 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S502) | Medtronic, Inc. | 2022-07-19 |