| LCS (R) Total Knee System (P830055/S329) | Depuy, Inc. | 2024-08-27 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S003) | Endotronix, Inc. | 2024-08-27 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi (P170002/S042) | Teoxane S.A. | 2024-08-27 |
| SURGICEL® Absorbable Hemostats (N12159/S114) | ETHICON, Inc. | 2024-08-27 |
| LifeVest® Wearable Defibrillator (P010030/S185) | Zoll Manufacturing Corporation | 2024-08-27 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S061) | ETHICON, Inc. | 2024-08-27 |
| LIPOSORBER® LA-15 System (P910018/S038) | Kaneka Pharma America Corp. | 2024-08-27 |
| Altius® Direct Electrical Nerve Stimulation System (P230020) | Neuros Medical, Inc. | 2024-08-26 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012) | Alcon Research, LLC | 2024-08-26 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S028) | Pulmonx Corporation | 2024-08-23 |
| POLARx FIT Cryoablation Balloon Catheters (P220032/S007) | Boston Scientific Corporation | 2024-08-23 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S223) | ABBOTT MEDICAL | 2024-08-23 |
| OrganOx metra System (P200035/S016) | Organox Limited | 2024-08-23 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S104) | ABBOTT MEDICAL | 2024-08-23 |
| Prospera SCS System (P210037/S004) | Biotronik Nro, Inc. | 2024-08-23 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| ESPRIT BTK Everolimus Eluting Bioresorbable Scaffold System (P230036/S004) | ABBOTT MEDICAL | 2024-08-23 |
| Angio-Seal VIP Vascular Closure Devices (P930038/S102) | Terumo Medical Corporation | 2024-08-23 |
| Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) (P150004/S076) | ABBOTT MEDICAL | 2024-08-23 |
| ColoSense (P230001/S001) | Geneoscopy, Inc. | 2024-08-23 |
| OrganOx metra® System (P200035/S004) | Organox Limited | 2024-08-22 |
| Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form (P810006/S109) | Integra LifeSciences Corporation | 2024-08-22 |
| ResQCPR System (P110024/S006) | ZOLL Medical Corporation | 2024-08-22 |
| AFX2 Endovascular AAA System (P040002/S073) | Endologix, LLC | 2024-08-22 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S068) | Ferrosan Meidcal Devices A/S | 2024-08-22 |
| Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S112) | Integra LifeSciences Corporation | 2024-08-22 |
| AFX2 Endovascular AAA System (P040002/S072) | Endologix, LLC | 2024-08-22 |
| Superion Indirect Decompression System (P140004/S033) | Boston Scientific Neuromodulation | 2024-08-22 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S002) | Endotronix, Inc. | 2024-08-22 |
| Sientra Silicone Gel Breast Implants (P070004/S044) | Tiger Aesthetics Medical, LLC | 2024-08-21 |
| TruSight Oncology Comprehensive (P230011) | Illumina, Inc. | 2024-08-21 |
| Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr (P170013/S012) | MicroVention, Inc. | 2024-08-21 |
| MicroTransponder Vivistim Paired VNS System (Vivistim System) (P210007/S003) | Mobia Medical, Inc. | 2024-08-21 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S011) | MicroVention, Inc. | 2024-08-21 |
| Symplicity G3 Renal Denervation RF Generator (P220026/S009) | Medtronic, Inc. | 2024-08-21 |
| Protégé GPS Self-Expanding Peripheral Stent System (P060001/S044) | Medtronic Vascular, Inc. | 2024-08-21 |
| Revanesse Versa; Revanesse Versa+ with Lidocaine, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse® Versa 1.2 mL, Reva (P160042/S024) | Prollenium Medical Technologies, Inc. | 2024-08-20 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S004) | Surmodics,Inc. | 2024-08-20 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) (P040044/S102) | Cordis US Corporation | 2024-08-20 |
| Comfilcon A Soft (Hydrophilic) contact lenses for extended wear (P080011/S170) | CooperVision, Inc. | 2024-08-20 |
| MiSight 1 Day (omafilcon A) (P180035/S023) | CooperVision, Inc. | 2024-08-20 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| M6-C Artificial Cervical Disc (P170036/S016) | Spinal Kinetics, LLC | 2024-08-19 |
| EUFLEXXA (P010029/S039) | Ferring Pharmaceuticals, Inc. | 2024-08-17 |
| Puregraft Serene Breast Implant (P120011/S025) | Bimini Health Tech | 2024-08-16 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S139) | W. L. Gore & Associates, Inc. | 2024-08-16 |
| CapSureFix Novus Lead (P930039/S262) | Medtronic, Inc. | 2024-08-16 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S014) | W. L. Gore & Associates, Inc. | 2024-08-16 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S050) | Allergan | 2024-08-16 |
| SYNERGY , SYNERGY XD, SYNERGY MEGATRON and SYNERGY Shield Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S104) | Boston Scientific Corporation | 2024-08-16 |
| Spiration® Valve System (P180007/S013) | Gyrus Acmi, Inc. | 2024-08-16 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust (P110023/S050) | Medtronic Vascular, Inc. | 2024-08-15 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S046) | Berlin Heart, Inc. | 2024-08-15 |
| Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S122) | ABBOTT MEDICAL | 2024-08-15 |
| Tunneling Tool (P920015/S291) | Medtronic, Inc. | 2024-08-15 |
| EMBLEM SICD Lead (P110042/S197) | Boston Scientific Corporation | 2024-08-15 |
| Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter (P210015/S002) | Avive Solutions, Inc. | 2024-08-15 |
| Optilume BPH Catheter System (P220029/S002) | Urotronic, Inc. | 2024-08-15 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S260) | Biotronik, Inc. | 2024-08-15 |
| Sientra Silicone Gel Breast Implants (P070004/S046) | Tiger Aesthetics Medical, LLC | 2024-08-15 |
| InterStim Therapy System, Verify® Evaluation System (P970004/S403) | Medtronic Neuromodulation | 2024-08-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S298) | Medtronic Neuromodulation | 2024-08-14 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S043) | Biotronik AG | 2024-08-14 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S016) | MicroVention, Inc. | 2024-08-14 |
| cobas HPV Test (P100020/S061) | Roche Molecular Systems, Inc. | 2024-08-14 |
| Guardian® System (P150009/S012) | Avertix Medical, Inc. | 2024-08-14 |
| TherOx DownStream System (P170027/S015) | Zoll Circulation, Inc. | 2024-08-14 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S430) | Medtronic, Inc. | 2024-08-14 |
| OPTIMIZER® Smart Mini (P180036/S029) | Impulse Dynamics (Usa), Inc. | 2024-08-13 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S007) | Edwards Lifesciences, LLC | 2024-08-13 |
| Harmony Transcathetrer Pulmonary Valve (P200046/S035) | Medtronic, Inc. | 2024-08-13 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S003) | W. L. Gore & Associates, Inc. | 2024-08-13 |
| Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic (P130021/S167) | Medtronic, Inc. | 2024-08-13 |
| NeuroPace RNS System (P100026/S095) | NeuroPace, Inc. | 2024-08-13 |
| RADIESSE® Injectable Implant (P050037/S129) | Merz North America, Inc. | 2024-08-12 |
| Sientra Silicone Gel Breast Implants (P070004/S043) | Tiger Aesthetics Medical, LLC | 2024-08-12 |
| Injection Molding Crimper 9600CR Components (P200015/S056) | Edwards Lifesciences, LLC | 2024-08-12 |
| PROVSIC Ophthalmic Viscosurgical Device (P890047/S065) | Alcon Research, Ltd. | 2024-08-12 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| Injection Molding Crimper 9600CR Components (P140031/S176) | Edwards Lifesciences, LLC | 2024-08-12 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE®(+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S151) | Merz North America, Inc. | 2024-08-12 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S110) | Alcon Research, Ltd. | 2024-08-09 |
| iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System (P930016/S067) | Amo Manufacturing USA, LLC | 2024-08-09 |
| Prometra Programmable Infusion Pump System (P080012/S073) | Infusyn Therapeutics, LLC | 2024-08-09 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S151) | Alcon Laboratories, Inc. | 2024-08-09 |
| Prestige LP (R) Cervical Disc (P090029/S021) | Medtronic Sofamor Danek USA, Inc. | 2024-08-09 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S037) | Alcon Laboratories, LLC | 2024-08-09 |
| TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S015) | Stryker Leibinger, GmbH & Co KG | 2024-08-08 |
| Deep Brain Stimulation (DBS) (P140009/S102) | ABBOTT MEDICAL | 2024-08-08 |
| Spinal Cord Stimulation (SCS) (P010032/S221) | ABBOTT MEDICAL | 2024-08-08 |
| ColoSense (P230001/S002) | Geneoscopy, Inc. | 2024-08-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S052) | Medinol, Ltd. | 2024-08-07 |
| iCast Covered Stent System (P120003/S005) | Atrium Medical Corp. | 2024-08-07 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S051) | Medinol, Ltd. | 2024-08-07 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S008) | Edwards Lifesciences, LLC | 2024-08-07 |
| prodisc C (P070001/S027) | Centinel Spine, LLC | 2024-08-07 |
| enVista® hydrophobic acrylic IOL, enVista® toric hydrophobic aryclic IOL, enVista® Aspire hydrophobic acrylic IOL, enVi (P910056/S056) | Bausch & Lomb, Inc. | 2024-08-07 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S025) | The Spectranetics Corp. | 2024-08-07 |
| Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S073) | Boston Scientific Corp | 2024-08-06 |