| Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S112) | Inspire Medical Systems | 2024-06-20 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040) | Endotronix, Inc. | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| RADIESSE® Injectable Implant (P050037/S139) | Merz North America, Inc. | 2024-06-18 |
| Plasmaflo OP-05W(A) (P820033/S018) | Asahi Kasei Medical Co., Ltd. | 2024-06-18 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S161) | Merz North America, Inc. | 2024-06-18 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S001) | Medtronic, Inc. | 2024-06-18 |
| FARAPULSE Pulsed Field Ablation System (P230030/S002) | Farapulse, Inc. | 2024-06-18 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S046) | W. L. Gore & Associates, Inc. | 2024-06-18 |
| Oncomine Dx Target Test (P160045/S045) | Life Technologies Corporation | 2024-06-17 |
| SENSAR® Soft Acrylic Posterior Chamber IOL (P980040/S168) | Johnson & Johnson Surgical Vision, Inc. | 2024-06-17 |
| Cobalt MRI CRTD, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S854) | Medtronic Cardiac Rhythm Disease Management | 2024-06-17 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S024) | The Spectranetics Corp. | 2024-06-17 |
| TECNIS® Multifocal 3-Piece IOL, Model ZMA00 (P080010/S025) | Johnson & Johnson Surgical Vision, Inc. | 2024-06-17 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |
| Cochlear Nucleus® CI522 cochlear implant with Slim Straight electrode, Cochlear Nucleus® CI532 cochlear implant with S (P970051/S227) | Cochlear Americas | 2024-06-17 |
| Aptima HBV Quant Assay (P170025/S019) | Hologic, Inc. | 2024-06-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S888) | Medtronic Cardiac Rhythm Disease Management | 2024-06-17 |
| TECNIS® Foldable Acrylic IOL with OptiEdge, Model ZA9003 (P990080/S060) | Johnson & Johnson Surgical Vision, Inc. | 2024-06-17 |
| PROVSIC Ophthalmic Viscosurgical Device (P890047/S064) | Alcon Research, Ltd. | 2024-06-17 |
| M6-C Artificial Cervical Disc (P170036/S014) | Spinal Kinetics, LLC | 2024-06-14 |
| LifeVest Wearable Defibrillator (P010030/S179) | Zoll Manufacturing Corporation | 2024-06-14 |
| cobas® HPV Test (P100020/S060) | Roche Molecular Systems, Inc. | 2024-06-14 |
| OPTIMIZER Smart, Smart Mini, and Lite Systems (P180036/S030) | Impulse Dynamics (Usa), Inc. | 2024-06-14 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S069) | Boston Scientific Corp | 2024-06-14 |
| PSW 2401.U, NEO 2401.U (P050023/S183) | Biotronik, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P070008/S157) | Biotronik, Inc. | 2024-06-13 |
| Oncomine Dx Target Test (P160045/S047) | Life Technologies Corporation | 2024-06-13 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S060) | ETHICON, Inc. | 2024-06-13 |
| OPTIMIZER® Smart Mini (P180036/S028) | Impulse Dynamics (Usa), Inc. | 2024-06-13 |
| Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock (P210037/S005) | Biotronik Nro, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P950037/S257) | Biotronik, Inc. | 2024-06-13 |
| SURGICEL® Absorbable Hemostats (N12159/S113) | ETHICON, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P000009/S110) | Biotronik, Inc. | 2024-06-13 |
| SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S064) | Ferrosan Meidcal Devices A/S | 2024-06-13 |
| Biofinity Sphere (comfilcon A) (P080011/S163) | CooperVision, Inc. | 2024-06-12 |
| Tendril MRI Pacing Lead (P140033/S090) | ABBOTT MEDICAL | 2024-06-12 |
| UltiPace Pacing Lead, Tendril STS Pacing Lead (P960013/S125) | ABBOTT MEDICAL | 2024-06-12 |
| CentriMag Circulatory Support System (P170038/S018) | Abbott | 2024-06-11 |
| Guardant360 CDx (P200010/S019) | Guardant Health, Inc. | 2024-06-11 |
| InterStim Therapy System, Verify Evaluation System (P970004/S397) | Medtronic Neuromodulation | 2024-06-11 |
| Clareon PanOptix Trifocal IOL (P190018/S034) | Alcon Laboratories, LLC | 2024-06-11 |
| Revanesse Versa; Revanesse Versa+ with Lidocaine; Revanesse Versa+ with Lidocaine 1.2 mL; Revanesse Versa 1.2 mL, Revan (P160042/S025) | Prollenium Medical Technologies, Inc. | 2024-06-11 |
| Perfluoron (P950018/S028) | Alcon Laboratories | 2024-06-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S292) | Medtronic Neuromodulation | 2024-06-11 |
| Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack (P200032/S001) | Occlutech Holding AG | 2024-06-07 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S012) | Teleflex Medical, LLC | 2024-06-07 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S861) | Medtronic Cardiac Rhythm Disease Management | 2024-06-07 |
| Magtrace and Sentimag Magnetic Locatization System (PUV) (P160053/S010) | Endomagnetics Ltd., | 2024-06-07 |
| Belotero Balance + Lidocaine Dermal Filler (P090016/S047) | Merz North America, Inc. | 2024-06-07 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S032) | Bausch & Lomb, Inc. | 2024-06-07 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S895) | Medtronic Cardiac Rhythm Disease Management | 2024-06-07 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S147) | Medtronic Cryocath, LP | 2024-06-07 |
| Aveir Delivery Catheter (P150035/S011) | ABBOTT MEDICAL | 2024-06-06 |
| TherOx Downstream System (P170027/S011) | Zoll Circulation, Inc. | 2024-06-06 |
| Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019) | Baxter Healthcare Corporation | 2024-06-06 |
| TherOx® DownStream® Cartridge (DSC-2) (P170027/S012) | Zoll Circulation, Inc. | 2024-06-06 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026) | Goodman Co., Ltd. | 2024-06-06 |
| Pipeline Vantage Embolization Device with Shield Technology (P100018/S043) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-06-06 |
| ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S039) | Biotronik AG | 2024-06-06 |
| SW016 / Application Software, SWCOMBO / Application Software, SW033 / Application Software (P980016/S893) | Medtronic Cardiac Rhythm Disease Management | 2024-06-05 |
| SW009, SW016, SWCOMBO / Application Software (P010031/S859) | Medtronic Cardiac Rhythm Disease Management | 2024-06-05 |
| EAZ101 / Epsila EV Sternal Tunneling Tool, EAZ201 / Epsila EV Transverse Tunneling Tool (P220012/S026) | Medtronic, Inc. | 2024-06-05 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S217) | Boston Scientific Corp | 2024-06-05 |
| SWCOMBO / Application Software, SW030 / Application Software (P980035/S782) | Medtronic, Inc. | 2024-06-05 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S043) | Berlin Heart, Inc. | 2024-06-05 |
| SWCOMBO / Application Software (P090013/S331) | Medtronic, Inc. | 2024-06-05 |
| SW026, SWCOMBO / Application Software, SW036 / Application Software, 29901 / CareLink Encore Programmer, 2090 / CareLink (P890003/S467) | Medtronic, Inc. | 2024-06-05 |
| SW044, SWCOMBO / Application Software, SW022 / Micra AV Programming Software Model (P150033/S189) | Medtronic, Inc. | 2024-06-05 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S539) | Medtronic, Inc. | 2024-06-05 |
| The enVista® intraocular lens (IOL) (P910056/S055) | Bausch & Lomb, Inc. | 2024-06-04 |
| LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S001) | DiaSorin, Inc. | 2024-06-04 |
| LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM (P180045/S014) | DiaSorin, Inc. | 2024-06-04 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S156) | Boston Scientific | 2024-06-04 |
| Aurora EV-ICD Application Software, Aurora EV-ICD (P220012/S018) | Medtronic, Inc. | 2024-06-04 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S044) | W. L. Gore & Associates, Inc. | 2024-06-04 |
| LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S025) | DiaSorin, Inc. | 2024-06-04 |
| LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual (P190017/S019) | DiaSorin, Inc. | 2024-06-04 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S292) | Boston Scientific Corp | 2024-06-04 |
| CRT-D MRI Application Software, Blackwell Application Software (P010031/S853) | Medtronic Cardiac Rhythm Disease Management | 2024-06-04 |
| LIAISON XL Murex Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifier (P180039/S016) | DiaSorin, Inc. | 2024-06-04 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S237) | Guidant Corp. | 2024-06-04 |
| LIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe (P180049/S015) | DiaSorin, Inc. | 2024-06-04 |
| LIAISON XL Murex Anti-HBc and LIAISON XL MUREX Control anti-HBc (P180038/S018) | DiaSorin, Inc. | 2024-06-04 |
| HP MRI Application Software, Visia AF Application Software (P980016/S887) | Medtronic Cardiac Rhythm Disease Management | 2024-06-04 |
| LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg (P180048/S015) | DiaSorin, Inc. | 2024-06-04 |
| T-SPOT.TB Test (P070006/S023) | Oxford Immunotec, Ltd. | 2024-06-04 |
| Integra® Dermal Regeneration Template (P900033/S112) | Integra Lifesciences Corp. | 2024-06-03 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S022) | Foundation Medicine, Inc. | 2024-06-03 |
| FoundationOne CDx (F1CDx) (P170019/S053) | Foundation Medicine, Inc. | 2024-06-03 |
| Silikon 1000 (P950008/S023) | Alcon | 2024-06-03 |
| Life Vest Wearable Defibrillator (P010030/S178) | Zoll Manufacturing Corporation | 2024-06-02 |
| Abre Venous Self-expanding Stent System (P200026/S009) | Medtronic Vascular, Inc. | 2024-05-31 |
| TriClip G4 System (P230007/S004) | ABBOTT MEDICAL | 2024-05-31 |
| MiSight 1 Day (omafilcon A) (P180035/S021) | CooperVision, Inc. | 2024-05-31 |
| LCS® Total Knee System (P830055/S322) | Depuy, Inc. | 2024-05-31 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S080) | ABBOTT MEDICAL | 2024-05-31 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S104) | ABBOTT MEDICAL | 2024-05-31 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL works (P190018/S035) | Alcon Laboratories, LLC | 2024-05-31 |
| Nucleus® 22 Cochlear Implant System (P890027/S065) | Cochlear Americas | 2024-05-31 |