| Edwards Commander Delivery System (P140031/S160) | Edwards Lifesciences, LLC | 2023-08-05 |
| Inspire UAS High AHI/High BMI (P130008/S099) | Inspire Medical Systems | 2023-08-04 |
| WALLSTENT Endoprosthesis (P930031/S073) | Boston Scientific Corp | 2023-08-04 |
| VENOUS WALLSTENT Self-Expanding Stent (P980033/S063) | Boston Scientific Corporation | 2023-08-04 |
| RelayPro Thoracic Stent-Graft System (P200045/S006) | Bolton Medical, Inc. | 2023-08-04 |
| THERMOCOOL SMARTTOUCH® SF (P040036/S091) | Biosense Webster, Inc. | 2023-08-03 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S281) | Medtronic Neuromodulation | 2023-08-03 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S413) | Medtronic, Inc. | 2023-08-03 |
| ID/SN Label (P960004/S104) | Boston Scientific | 2023-08-03 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S140) | Boston Scientific Corp | 2023-08-03 |
| OPTIMIZER Smart Mini (OSM) system (P180036/S021) | Impulse Dynamics (Usa), Inc. | 2023-08-03 |
| 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/S756) | Medtronic, Inc. | 2023-08-03 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S386) | Medtronic Neuromodulation | 2023-08-03 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S456) | Medtronic, Inc. | 2023-08-03 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S545) | Medtronic Neuromodulation | 2023-08-03 |
| THERMOCOOL SMARTTOUCH® (P030031/S129) | Biosense Webster, Inc. | 2023-08-03 |
| Silikon 1000 (P950008/S016) | Alcon | 2023-08-02 |
| 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/S757) | Medtronic, Inc. | 2023-08-01 |
| Epicardial Patch Lead, Epicardial Patch Lead, Upsizing Sleeve (P900061/S171) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S035) | Highridge Medical, LLC | 2023-08-01 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S178) | Medtronic, Inc. | 2023-08-01 |
| Transvene CS/SVC Lead (P980050/S141) | Medtronic, Inc. | 2023-08-01 |
| Attain Bipolar OTW Lead, Attain OTW L V Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Seren (P010015/S524) | Medtronic, Inc. | 2023-08-01 |
| SKINVIVE by Juvederm (P110033/S072) | Allergan | 2023-08-01 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve System, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valv (P130021/S142) | Medtronic, Inc. | 2023-08-01 |
| CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead (P830061/S218) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S114) | Medtronic, Inc. | 2023-08-01 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead, Subcut (P920015/S280) | Medtronic, Inc. | 2023-08-01 |
| Myocardial Pacing Lead (P120017/S033) | Medtronic, Inc. | 2023-08-01 |
| CapSureFix Novus Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S254) | Medtronic, Inc. | 2023-08-01 |
| LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S035) | Highridge Medical, LLC | 2023-08-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S085) | Syncardia Systems, LLC | 2023-08-01 |
| CapSureFix MRI Lead (P090013/S329) | Medtronic, Inc. | 2023-08-01 |
| 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, Ev (P980016/S864) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead (P850089/S166) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| SelectSecure Lead (P030036/S144) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| CapSure Epicardial Pacing Lead (P950024/S108) | Medtronic, Inc. | 2023-08-01 |
| 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/S830) | Medtronic Cardiac Rhythm Disease Management | 2023-08-01 |
| HFX App (P130022/S049) | Nevro Corporation | 2023-08-01 |
| IC-8 Apthera Intraocular Lens (P210005/S005) | Acu Focus, Inc. | 2023-07-31 |
| Silicone Gel Breast Implants (P070004/S027) | Tiger Aesthetics Medical, LLC | 2023-07-31 |
| CardioMEMS Hospital System (P100045/S066) | ABBOTT MEDICAL | 2023-07-28 |
| R3 Delta Ceramic Hip System (P150030/S031) | Smith & Nephew, Inc. | 2023-07-28 |
| Minitouch 3.8 Era System (Minitouch System) (P230002) | Microcube, LLC | 2023-07-28 |
| Juvéderm Injectable Gel Implant (P050047/S089) | Allergan | 2023-07-28 |
| LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S001) | Advanced Medical Solutions Limited | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION Coronary Orbital Atherectomy System (OAS) (P130005/S037) | Cardiovascular Systems, Inc. | 2023-07-28 |
| Medtronic Evolut R Transcatheter Aortic Valve Replacement System, Medtronic Evolut PRO Transcatheter Aortic Valve Replac (P130021/S140) | Medtronic, Inc. | 2023-07-28 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S076) | Boston Scientific Corp | 2023-07-27 |
| Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav (P150038/S028) | Insightec | 2023-07-27 |
| WOLVERINE Coronary Cutting Balloon (P950020/S139) | Boston Scientific Corp | 2023-07-27 |
| Agilent Resolution ctDx FIRST (P210040/S001) | Exact Sciences Corporation | 2023-07-27 |
| Cordis® PRECISE® Nitinol Stent System (P030047/S047) | Cordis US Corporation | 2023-07-27 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |
| LifeStent Vascular Stent System (P070014/S065) | Bard Peripheral Vascular, Inc. | 2023-07-27 |
| Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S024) | Cordis US Corporation | 2023-07-27 |
| Express® SD Renal Monorail Premounted Stent System (P060006/S107) | Boston Scientific Corp | 2023-07-27 |
| `Cordis® S.M.A.R.T.® CONTROL Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ TM Vascular Stent System (P020036/S049) | Cordis US Corporation | 2023-07-27 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S078) | Boston Scientific Corp | 2023-07-27 |
| Chilli Cooled Rf Ablation System (P980003/S096) | Boston Scientific Corp | 2023-07-27 |
| Spinal Cord Stimulation (SCS) System (P010032/S195) | ABBOTT MEDICAL | 2023-07-27 |
| Rotablator Rotational Atherectomy System (P900056/S209) | Boston Scientific Corp | 2023-07-27 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S211) | Boston Scientific Corp | 2023-07-27 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S140) | Boston Scientific | 2023-07-27 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S022) | Boston Scientific Corporation | 2023-07-27 |
| Exablate Model 4000 System (P150038/S031) | Insightec | 2023-07-27 |
| Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav (P150038/S027) | Insightec | 2023-07-27 |
| Blazer II Cardiac Ablation System and Cable (P920047/S132) | Boston Scientific Corp | 2023-07-27 |
| Melody Transcatheter Pulmonary Valve System (P140017/S024) | Medtronic, Inc. | 2023-07-27 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S081) | ABBOTT MEDICAL | 2023-07-27 |
| INSPIRIS RESILIA Aortic Valve, Model 11500A (P150048/S073) | Edwards Lifesciences, LLC | 2023-07-27 |
| Adaptor Assembly Cable, Analzer Cable, CareLink Encore Programmer, CareLink SmartSync Device Manager Patient Connector, (P890003/S462) | Medtronic, Inc. | 2023-07-26 |
| TheraSphere (P200029/S005) | Boston Scientific Corporation | 2023-07-26 |
| Patient Cable (P820003/S140) | Medtronic Cardiac Rhythm Disease Management | 2023-07-26 |
| CardioMEMS HF System (P100045/S068) | ABBOTT MEDICAL | 2023-07-26 |
| VenaSeal Closure System (P140018/S037) | Medtronic Vascular, Inc. | 2023-07-25 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S141) | Medtronic, Inc. | 2023-07-25 |
| Accessory, Cap, Accessory, Plug (P910077/S192) | Boston Scientific | 2023-07-21 |
| Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P150004/S062) | ABBOTT MEDICAL | 2023-07-21 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P010032/S199) | ABBOTT MEDICAL | 2023-07-21 |
| FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US (P960004/S105) | Boston Scientific | 2023-07-21 |
| DiamondTemp Unidirectional Ablation Catheter, Small Curve, DiamondTemp Unidirectional Ablation Catheter, Large Curve, (P200028/S020) | Medtronic, Inc. | 2023-07-21 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI (P960040/S496) | Boston Scientific | 2023-07-21 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P140009/S085) | ABBOTT MEDICAL | 2023-07-21 |
| Accessory, Wrench (P930035/S034) | Boston Scientific | 2023-07-21 |
| OPTIMIZER Smart and Smart Mini (P180036/S019) | Impulse Dynamics (Usa), Inc. | 2023-07-21 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S159) | W. L. Gore & Associates, Inc. | 2023-07-21 |
| EMBLEM S-ICD, EMBLEM MRI S-ICD (P110042/S188) | Boston Scientific Corporation | 2023-07-21 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S232) | Guidant Corp. | 2023-07-21 |
| - ESSENTIO SR, ESSENTIO DR, SSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR (N970003/S287) | Boston Scientific Corp | 2023-07-21 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S098) | W. L. Gore & Associates, Inc. | 2023-07-21 |
| Exablate 4000 (Exablate Neuro) (P150038/S029) | Insightec | 2023-07-21 |
| Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT, A (P910073/S173) | Boston Scientific | 2023-07-21 |
| ACUITY Spiral, Accessory, Slit Suture Sleeve, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L, Slit Sutu (P010012/S575) | Boston Scientific Corp | 2023-07-21 |
| Exablate Model 4000 System (P150038/S030) | Insightec | 2023-07-21 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004) | Cordis US Corp | 2023-07-21 |
| Accessory, Stabilizer (P960006/S056) | Boston Scientific | 2023-07-21 |
| ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St (P150012/S148) | Boston Scientific | 2023-07-21 |
| Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI (P830060/S089) | Boston Scientific | 2023-07-21 |