| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030) | Alcon Research, LLC | 2024-07-02 |
| Oncomine Dx Target Test (P160045/S048) | Life Technologies Corporation | 2024-07-02 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S003) | Surmodics,Inc. | 2024-07-02 |
| INOUE BALLOON CATHETER (P910054/S010) | Toray Industries (America), Inc. | 2024-07-01 |
| Protege GPS Self-Expanding Peripheral Stent System (P060001/S042) | Medtronic Vascular, Inc. | 2024-07-01 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S474) | Medtronic, Inc. | 2024-07-01 |
| STAR S4 IR Excimer Laser (P930016/S065) | Amo Manufacturing USA, LLC | 2024-07-01 |
| cobas HPV (P190028/S015) | Roche Molecular Systems, Inc. | 2024-07-01 |
| CapSureFix MRI Lead (P090013/S332) | Medtronic, Inc. | 2024-07-01 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S260) | Medtronic, Inc. | 2024-07-01 |
| Roche cobas HBV (P150014/S050) | Roche Molecular Systems, Inc. | 2024-07-01 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S016) | Edwards Lifesciences, LLC | 2024-07-01 |
| RF Catheter Cables (P930029/S072) | Medtronic, Inc. | 2024-07-01 |
| Transvene CS/SVC Lead (P920015/S289) | Medtronic, Inc. | 2024-07-01 |
| cobas CMV (P160041/S041) | Roche Molecular Systems, Inc. | 2024-07-01 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S047) | Medtronic Vascular, Inc. | 2024-07-01 |
| CapSure SP Z Lead (P850089/S167) | Medtronic Cardiac Rhythm Disease Management | 2024-07-01 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+ VDD Lead (P890003/S468) | Medtronic, Inc. | 2024-07-01 |
| CapSure Sense Lead (P830061/S223) | Medtronic Cardiac Rhythm Disease Management | 2024-07-01 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S048) | Medtronic Vascular, Inc. | 2024-07-01 |
| Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock (P210037/S008) | Biotronik Nro, Inc. | 2024-07-01 |
| HYALGAN® (P950027/S019) | Fidia Farmaceutici S.P.A. | 2024-06-28 |
| HYMOVIS® (P150010/S003) | Fidia Farmaceutici | 2024-06-28 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System (P210037/S007) | Biotronik Nro, Inc. | 2024-06-28 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S401) | Medtronic Neuromodulation | 2024-06-28 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S481) | Medtronic, Inc. | 2024-06-28 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S014) | Foundation Medicine, Inc. | 2024-06-28 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S429) | Medtronic, Inc. | 2024-06-28 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S002) | Boston Scientific Corporation | 2024-06-28 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S296) | Medtronic Neuromodulation | 2024-06-28 |
| Akreos Posterior Chamber Intraocular Lens (P060022/S033) | Bausch & Lomb, Inc. | 2024-06-28 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S086) | Intera Oncology | 2024-06-28 |
| TRILURON® (P180040/S005) | Fidia Farmaceutici S.P.A. | 2024-06-28 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S045) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter IN.PACT 018 Paclitaxel-Co (P140010/S081) | Medtronic, Inc. | 2024-06-27 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S076) | Boston Scientific Corp | 2024-06-27 |
| MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F (P040044/S097) | Cordis US Corporation | 2024-06-27 |
| RHA® Redensity, RHA® Redensity Mepi, RHA®2, RHA®2 Mepi, RHA®3, RHA®3 Mepi, RHA®4, RHA®4 Mepi (P170002/S035) | Teoxane S.A. | 2024-06-27 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S184) | Medtronic, Inc. | 2024-06-27 |
| Spiration Valve System Deployment Catheter and Loader (P180007/S012) | Gyrus Acmi, Inc. | 2024-06-27 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S104) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S030) | Medtronic Vascular, Inc. | 2024-06-27 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S480) | Medtronic, Inc. | 2024-06-27 |
| R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S040) | Smith & Nephew, Inc. | 2024-06-27 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S288) | Medtronic, Inc. | 2024-06-27 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S165) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| LifeVest Wearable Defibrillator, Model 5100 (P010030/S180) | Zoll Manufacturing Corporation | 2024-06-27 |
| Epsila EV Extravascular Lead (P220012/S028) | Medtronic, Inc. | 2024-06-27 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X (P980035/S783) | Medtronic, Inc. | 2024-06-27 |
| GORE TAG Thoracic Branch Endoprosthesis (P210032/S013) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S066) | Boston Scientific Scimed, Inc. | 2024-06-27 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S066) | Boston Scientific Corporation | 2024-06-27 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S541) | Medtronic, Inc. | 2024-06-27 |
| Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S024) | ABBOTT MEDICAL | 2024-06-26 |
| Amplatzer Muscular VSD Occluder (P040040/S046) | ABBOTT MEDICAL | 2024-06-26 |
| TREO Abdominal Stent-Graft System (P190015/S019) | Bolton Medical, Inc. | 2024-06-26 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S006) | ABBOTT MEDICAL | 2024-06-26 |
| LIFEPAK 35 Monitor/Defibrillator, LIFEPAK FLEX Battery (P160026/S050) | Physio-Control, Inc. | 2024-06-26 |
| Family of DBS IPGs (P140009/S095) | ABBOTT MEDICAL | 2024-06-26 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S068) | ABBOTT MEDICAL | 2024-06-26 |
| Family of SCS IPGs (P010032/S213) | ABBOTT MEDICAL | 2024-06-26 |
| Surpass Elite Flow Diverter System (P170024/S017) | Stryker Neurovascular | 2024-06-26 |
| Family of DRG IPGs (P150004/S071) | ABBOTT MEDICAL | 2024-06-26 |
| Amplatzer Multifenestrated Septal Occluder Cribriform (P000039/S078) | ABBOTT MEDICAL | 2024-06-26 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S002) | ABBOTT MEDICAL | 2024-06-25 |
| T SPOT-TB TEST (P070006/S025) | Oxford Immunotec, Ltd. | 2024-06-25 |
| INTELLANAV STABLEPOINT Ablation Catheter (P150005/S084) | Boston Scientific Corp | 2024-06-25 |
| Radiesse (+) Lidocaine dermal filler (P050052/S163) | Merz North America, Inc. | 2024-06-25 |
| Juvederm Volux XC (P110033/S082) | Allergan | 2024-06-24 |
| Precision Spional Cord Stimulator (SCS) Systems (P030017/S375) | Boston Scientific Corp | 2024-06-21 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S003) | ABBOTT MEDICAL | 2024-06-21 |
| LifePulse High Frequency Ventilator (P850064/S052) | Bunnell, Inc. | 2024-06-21 |
| Guardian System (P150009/S013) | Avertix Medical, Inc. | 2024-06-21 |
| Juvederm, Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S086) | Allergan | 2024-06-21 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S075) | Medtronic Vascular | 2024-06-21 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S172) | Edwards Lifesciences, LLC | 2024-06-21 |
| NATRELLE® Saline-Filled Breast Implants (P990074/S053) | Allergan | 2024-06-21 |
| LifeVest® Wearable Defibrillator (P010030/S181) | Zoll Manufacturing Corporation | 2024-06-21 |
| NATRELLE® Silicone-Filled Breast Implants (P020056/S063) | Allergan | 2024-06-21 |
| Guardant360 CDx (P200010/S020) | Guardant Health, Inc. | 2024-06-21 |
| Revanesse Versa, Revanesse Versa+ (with lidocaine), Revanesse Lips+ (with lidocaine) (P160042/S016) | Prollenium Medical Technologies, Inc. | 2024-06-21 |
| therascreen® KRAS RGQ PCR Kit (P110027/S017) | QIAGEN GmbH | 2024-06-21 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S002) | W. L. Gore & Associates, Inc. | 2024-06-21 |
| LCS Total Knee System (P830055/S324) | Depuy, Inc. | 2024-06-21 |
| Ultra, Ultra XC, Ultra Plus XC (P050047/S095) | Allergan | 2024-06-21 |
| HV Splitter/Adaptor kit (P920015/S287) | Medtronic, Inc. | 2024-06-21 |
| Gore Excluder Conformable AAA Endoprosthesis (CEXC) (P200030/S017) | W. L. Gore and Associates, Inc. | 2024-06-21 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S179) | Biotronik, Inc. | 2024-06-21 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S079) | Medtronic, Inc. | 2024-06-21 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S074) | Boston Scientific Corp | 2024-06-21 |
| Restore, Itrel, Synergy, Intellis Vanta, and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris S (P840001/S565) | Medtronic Neuromodulation | 2024-06-20 |
| Core Valve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Valve EnVeo R Delivery Catheter Sys (P130021/S164) | Medtronic, Inc. | 2024-06-20 |
| TOPS System (P220002/S004) | Premia Spine, Ltd. | 2024-06-20 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S150) | Alcon Laboratories, Inc. | 2024-06-20 |
| TriClip G4 Delivery System (P230007/S002) | ABBOTT MEDICAL | 2024-06-20 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S109) | Alcon Research, Ltd. | 2024-06-20 |
| MitraClip G4 Clip Delivery System (P100009/S065) | ABBOTT MEDICAL | 2024-06-20 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S036) | Alcon Laboratories, LLC | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |