| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S097) | W. L. Gore & Associates, Inc. | 2024-09-12 |
| Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN (P860057/S219) | Edwards Lifesciences, LLC | 2024-09-12 |
| 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/S787) | Medtronic, Inc. | 2024-09-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S178) | Edwards Lifesciences, LLC | 2024-09-12 |
| Aurora EV-ICD (P220012/S030) | Medtronic, Inc. | 2024-09-12 |
| Edwards Commander Delivery System (P200015/S057) | Edwards Lifesciences, LLC | 2024-09-11 |
| cobas HPV (P190028/S016) | Roche Molecular Systems, Inc. | 2024-09-11 |
| HeartMate 3 Left Ventricular Assist System (P160054/S085) | ABBOTT MEDICAL | 2024-09-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S018) | Edwards Lifesciences, LLC | 2024-09-11 |
| Edwards Commander Delivery System (P140031/S177) | Edwards Lifesciences, LLC | 2024-09-11 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S063) | Roche Molecular Systems, Inc. | 2024-09-11 |
| cobas CMV (P160041/S042) | Roche Molecular Systems, Inc. | 2024-09-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S019) | Edwards Lifesciences, LLC | 2024-09-11 |
| cobas HBV (P150014/S051) | Roche Molecular Systems, Inc. | 2024-09-11 |
| COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0 (P050028/S093) | Roche Molecular Systems, Inc. | 2024-09-11 |
| HeartMate II Left Ventricular Assist System (P060040/S107) | ABBOTT MEDICAL | 2024-09-11 |
| HeartStart FR3 Primary Battery (989803150161) (P160028/S005) | Philips Medical Systems, Inc. | 2024-09-11 |
| GORE® VIABAHN® Endoprosthesis (P040037/S166) | W. L. Gore & Associates, Inc. | 2024-09-10 |
| Protégé RX Carotid Stent System (P060001/S045) | Medtronic Vascular, Inc. | 2024-09-10 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS) (P100044/S052) | Intersect Ent. | 2024-09-10 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S105) | W. L. Gore & Associates, Inc. | 2024-09-10 |
| Abre Venous Self-expanding Stent Systems Self-expanding Stent System (P200026/S011) | Medtronic Vascular, Inc. | 2024-09-10 |
| R3TM DELTA CERAMIC ACETABULAR SYSTEM (P150030/S044) | Smith & Nephew, Inc. | 2024-09-10 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S051) | Medtronic Vascular, Inc. | 2024-09-09 |
| OrganOx metra® System (P200035/S017) | Organox Limited | 2024-09-09 |
| INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS (P980031/S013) | Addition Technology | 2024-09-09 |
| enVista Hydrophobic Acrylic Intraocular Lens (P910056/S057) | Bausch & Lomb, Inc. | 2024-09-06 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S093) | Hologic, Inc. | 2024-09-06 |
| ColoSense® (P230001/S004) | Geneoscopy, Inc. | 2024-09-06 |
| Defibtech Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E (P160032/S011) | Defibtech, LLC | 2024-09-06 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S018) | W. L. Gore and Associates, Inc. | 2024-09-06 |
| PulseSelect PFA Loop Catheter (P230017/S003) | Medtronic, Inc. | 2024-09-06 |
| BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test (P970018/S041) | Bd Diagnostic Systems | 2024-09-06 |
| Alinity m CMV Assay (P210022/S013) | Abbott Molecular, Inc. | 2024-09-05 |
| Alinity m HBV Assay (P200013/S022) | Abbott Molecular, Inc. | 2024-09-05 |
| Alinity m HR HPV Assay (P230003/S005) | Abbott Molecular, Inc. | 2024-09-05 |
| Surpass Evolve and Elite Flow Diverter (P170024/S020) | Stryker Neurovascular | 2024-09-05 |
| Spectranetics Laser Sheath (GlideLight/SLS) (P960042/S072) | Spectranetics (Philips) | 2024-09-05 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004/S002) | Cordis US Corp | 2024-09-05 |
| ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) (P910001/S122) | Spectranetics Corp. | 2024-09-05 |
| LIAISON® QuantiFERON®-TB Gold Plus, LIAISON® Control QuantiFERON®-TB Gold Plus (P180047/S027) | DiaSorin, Inc. | 2024-09-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S067) | Medtronic Vascular | 2024-09-05 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S087) | Allergan | 2024-09-04 |
| Vercise Genus Deep Brain Stimulation (DBS) Systems (P150031/S077) | Boston Scientific Corp | 2024-09-04 |
| Axonics Sacral Neuromodulation System (P190006/S087) | Boston Scientific Corporation | 2024-09-04 |
| Axonics Sacral Neuromodulation System (P180046/S087) | Boston Scientific Corporation | 2024-09-04 |
| Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta (P220007/S005) | Alcon Laboratories, Inc. | 2024-09-04 |
| Ultra, Ultra XC, Ultra Plus XC (P050047/S096) | Allergan | 2024-09-04 |
| Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S001) | Agilent Technologies, Inc. | 2024-09-04 |
| 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/S786) | Medtronic, Inc. | 2024-09-04 |
| Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo (P000009/S113) | Biotronik, Inc. | 2024-09-03 |
| Bulkamid Urethral Bulking System (P170023/S018) | Boston Scientific Corporation | 2024-09-03 |
| Light Adjustable Lens, Light Delivery Device (P160055/S039) | Rxsight, Inc. | 2024-09-03 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S186) | Biotronik, Inc. | 2024-09-03 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T (P980023/S128) | Biotronik, Inc. | 2024-09-03 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S013) | Kestra Medical Technologies, Inc. | 2024-09-03 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S085) | Intera Oncology | 2024-09-03 |
| Elecsys total PSA (P990056/S043) | Roche Diagnostics Corp. | 2024-08-30 |
| Elecsys free PSA (P000027/S041) | Roche Diagnostics Corp. | 2024-08-30 |
| GUARDIO/VESTA Charger firmware (P180036/S031) | Impulse Dynamics (Usa), Inc. | 2024-08-30 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S009) | Edwards Lifesciences, LLC | 2024-08-30 |
| R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products (P150030/S042) | Smith & Nephew, Inc. | 2024-08-30 |
| Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S113) | Inspire Medical Systems | 2024-08-30 |
| FoundationOne®Liquid CDx (F1LCDx) (P190032/S016) | Foundation Medicine, Inc. | 2024-08-30 |
| FoundationOne®CDx (F1CDx) (P170019/S052) | Foundation Medicine, Inc. | 2024-08-30 |
| HeartWare® HVAD System (P100047/S220) | Medtronic | 2024-08-30 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable (P950037/S255) | Biotronik, Inc. | 2024-08-30 |
| Elecsys Anti-HBc II (P100031/S031) | Roche Diagnostics Corp. | 2024-08-29 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S865) | Medtronic Cardiac Rhythm Disease Management | 2024-08-29 |
| Lutonix Drug Coated Balloon PTA Catheter (P170003/S026) | Lutonix | 2024-08-29 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S899) | Medtronic Cardiac Rhythm Disease Management | 2024-08-29 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form (P810006/S110) | Integra LifeSciences Corporation | 2024-08-29 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S093) | Integra Lifesciences Corp. | 2024-08-29 |
| Aveir VR Delivery Catheter, Aveir DR Delivery Catheter (P150035/S015) | ABBOTT MEDICAL | 2024-08-29 |
| Elecsys Anti-HBs (P010054/S046) | Roche Diagnostics Corp. | 2024-08-29 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S020) | Stryker Leibinger GmbH & Co KG | 2024-08-29 |
| CardioMEMS HF System (P100045/S076) | ABBOTT MEDICAL | 2024-08-29 |
| Elecsys Anti-HBc IgM (P110022/S032) | Roche Diagnostics Corp. | 2024-08-29 |
| Elecsys HBeAg (P130015/S020) | Roche Diagnostics Operations, Inc. | 2024-08-29 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys HBsAg II (P160019/S017) | Roche Diagnostics, Inc. | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form (P850010/S113) | Integra LifeSciences Corporation | 2024-08-29 |
| MyChoice CDx (P190014/S009) | Myriad Genetic Laboratories, Inc. | 2024-08-29 |
| Advanced Valve Metal (AVM) capacitor (P220012/S029) | Medtronic, Inc. | 2024-08-28 |
| Cardiac Resynchronization Therapy Pacemaker (CRT-P) (P030005/S240) | Guidant Corp. | 2024-08-28 |
| Cannula with Guide (P200002/S009) | AtriCure, Inc. | 2024-08-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S084) | ABBOTT MEDICAL | 2024-08-28 |
| Advanced Valve Metal (AVM) capacitor (P010031/S864) | Medtronic Cardiac Rhythm Disease Management | 2024-08-28 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S186) | Zoll Manufacturing Corporation | 2024-08-28 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S006) | ABBOTT MEDICAL | 2024-08-28 |
| SURGICEL® Absorbable Hemostats (SURGICEL® SNOW) (N12159/S115) | ETHICON, Inc. | 2024-08-28 |
| Hydrus® Microstent (P170034/S011) | Alcon Research, LLC | 2024-08-28 |
| Minima Stent System (P240003) | Renata Medical, Inc. | 2024-08-28 |
| HeartMate II Left Ventricular Assist System (P060040/S106) | ABBOTT MEDICAL | 2024-08-28 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S585) | Boston Scientific Corp | 2024-08-28 |
| Medtronic SelectSecure Lead Model 3830 (P030036/S147) | Medtronic Cardiac Rhythm Disease Management | 2024-08-28 |
| Advanced Valve Metal (AVM) capacitor (P980016/S898) | Medtronic Cardiac Rhythm Disease Management | 2024-08-28 |
| EluNIR & EluNIR-PERL Ridaforolimus Eluting Coronary Stent Systems (P170008/S049) | Medinol, Ltd. | 2024-08-27 |