| Merlin.net MN5000 (P030054/S418) | ABBOTT MEDICAL | 2024-10-11 |
| AVEIR Patient Transmitter, AVEIR Patient Transmitter Software, AVEIR Patient Trasmitter Wired Electrodes, Merlin.net (P150035/S007) | ABBOTT MEDICAL | 2024-10-11 |
| Merlin.net MN5000 (P910023/S463) | ABBOTT MEDICAL | 2024-10-11 |
| Percept Deep Brain Stimulation Therapy System (P960009/S487) | Medtronic, Inc. | 2024-10-11 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (P240009) | Contego Medical, Inc. | 2024-10-11 |
| Merlin.net MN5000 (P030035/S199) | ABBOTT MEDICAL | 2024-10-11 |
| Organ Care System (OCS) Liver (P200031/S009) | TransMedics, Inc. | 2024-10-11 |
| LIAISON QuantiFERON-TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S028) | DiaSorin, Inc. | 2024-10-11 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S068) | Medtronic Vascular | 2024-10-10 |
| MiniMed 780G System (P160017/S121) | Medtronic Minimed, Inc. | 2024-10-10 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S004) | Endotronix, Inc. | 2024-10-10 |
| COBAS EGFR MUTATION TEST (P120019/S040) | Roche | 2024-10-10 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S023) | Foundation Medicine, Inc. | 2024-10-10 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005) | Bausch & Lomb, Inc. | 2024-10-10 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S124) | Medtronic Vascular | 2024-10-10 |
| Saluda Medical Evoke® SCS System (P190002/S030) | Saluda Medical Pty, Ltd. | 2024-10-10 |
| cobas® EZH2 Mutation Test (P200014/S009) | Roche Molecular System, Inc. | 2024-10-10 |
| COBAS CMV (P160041/S045) | Roche Molecular Systems, Inc. | 2024-10-10 |
| PK-175/2,3m Patient Cable, PK-83, 2.5m (P950037/S263) | Biotronik, Inc. | 2024-10-09 |
| SCULPTRA (P030050/S051) | Q-Med AB | 2024-10-09 |
| samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr (P160008/S026) | Heartsine Technologies, Ltd. | 2024-10-09 |
| GORE CARDIOFORM ASD Occluder (P050006/S112) | W. L. Gore & Associates, Inc. | 2024-10-09 |
| MynxGrip Vascular Closure Device (5F, 6F/7F) (P040044/S104) | Cordis US Corporation | 2024-10-09 |
| TactiCath Contact Force Ablation Catheter (P130026/S090) | St Jude Medical | 2024-10-09 |
| TW Torque wrench (P980023/S130) | Biotronik, Inc. | 2024-10-09 |
| TactiFlex Ablation Catheter, Sensor Enabled, TactiCath Contact Force Ablation Catheter, Sensor Enabled (P220013/S013) | ABBOTT MEDICAL | 2024-10-09 |
| Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive (P150038/S036) | Insightec | 2024-10-08 |
| Genesis Neurostimulation System (P010032/S211) | ABBOTT MEDICAL | 2024-10-08 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S014) | Kestra Medical Technologies, Inc. | 2024-10-08 |
| Axium Neurostimulator System (P150004/S069) | ABBOTT MEDICAL | 2024-10-08 |
| AMS 800 Artificial Urinary Sphincter (with and without InhibiZone) (P000053/S130) | Boston Scientific Corp | 2024-10-08 |
| Brio Neurostimulation System (P140009/S093) | ABBOTT MEDICAL | 2024-10-08 |
| Elecsys free PSA Assay (P000027/S042) | Roche Diagnostics Corp. | 2024-10-08 |
| MiniMed 780G System (P160017/S120) | Medtronic Minimed, Inc. | 2024-10-07 |
| Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler (P090016/S063) | Merz North America, Inc. | 2024-10-07 |
| MiSight 1 Day (omafilcon A) (P180035/S024) | CooperVision, Inc. | 2024-10-07 |
| Surpass Evolve Flow Diverter Systems, Surpass Elite Flow Diverter Systems (P170024/S021) | Stryker Neurovascular | 2024-10-06 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S064) | Roche Molecular Systems, Inc. | 2024-10-04 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S001) | Endotronix, Inc. | 2024-10-04 |
| cobas HBV (P150014/S052) | Roche Molecular Systems, Inc. | 2024-10-04 |
| MyChoice® CDx (P190014/S010) | Myriad Genetic Laboratories, Inc. | 2024-10-04 |
| AAV5 DetectCDx® (P190033/S001) | ARUP Laboratories | 2024-10-04 |
| cobas CMV (P160041/S043) | Roche Molecular Systems, Inc. | 2024-10-04 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S094) | Roche Molecular Systems, Inc. | 2024-10-04 |
| cobas HPV (P190028/S017) | Roche Molecular Systems, Inc. | 2024-10-04 |
| BRACAnalysis CDx® (P140020/S029) | Myriad Genetic Laboratories | 2024-10-04 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S005) | Endotronix, Inc. | 2024-10-03 |
| MED-EL CI System (P000025/S129) | Med-El Corp. | 2024-10-03 |
| Elecsys HBsAg II (P160019/S018) | Roche Diagnostics, Inc. | 2024-10-03 |
| Ellipse DR, Ellipse VR (P910023/S471) | ABBOTT MEDICAL | 2024-10-03 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE) (P210032/S016) | W. L. Gore & Associates, Inc. | 2024-10-03 |
| Elecsys HBeAg (P130015/S021) | Roche Diagnostics Operations, Inc. | 2024-10-03 |
| Elecsys Anti-HBc II / Elecsys Anti-HBc IgM (P110022/S033) | Roche Diagnostics Corp. | 2024-10-03 |
| Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus (P230043) | Exact Sciences Corporation | 2024-10-03 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S004) | Edwards Lifesciences, LLC | 2024-10-03 |
| LCS Total Knee System (P830055/S333) | Depuy, Inc. | 2024-10-03 |
| Elecsys Anti-HBc IgM (P110031/S026) | Roche Diagnostics Corp. | 2024-10-03 |
| TherOx Downstream System (P170027/S014) | Zoll Circulation, Inc. | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBc II / Elecsys Anti-HBc IgM (P100031/S032) | Roche Diagnostics Corp. | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P010054/S047) | Roche Diagnostics Corp. | 2024-10-03 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S069) | Coloplast Corp. | 2024-10-02 |
| cobas CMV (P160041/S044) | Roche Molecular Systems, Inc. | 2024-10-02 |
| cobas HBV (P150014/S053) | Roche Molecular Systems, Inc. | 2024-10-02 |
| Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler (P090016/S061) | Merz North America, Inc. | 2024-10-02 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S053) | Intersect Ent. | 2024-10-02 |
| SCULPTRA® (injectable poly-L Lactic acid) (P030050/S052) | Q-Med AB | 2024-10-02 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S168) | Medtronic Cardiac Rhythm Disease Management | 2024-10-01 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S472) | Medtronic, Inc. | 2024-10-01 |
| Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S025) | ABBOTT MEDICAL | 2024-10-01 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S007) | ABBOTT MEDICAL | 2024-10-01 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S224) | Medtronic Cardiac Rhythm Disease Management | 2024-10-01 |
| EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), (P030016/S045) | STAAR Surgical Company | 2024-10-01 |
| SelectSecure Lead (P030036/S148) | Medtronic Cardiac Rhythm Disease Management | 2024-10-01 |
| IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead (P920015/S292) | Medtronic, Inc. | 2024-10-01 |
| Amplatzer Septal Occluder, Amplatzer Multifenestrated Septal Occluder Cribriform (P000039/S079) | ABBOTT MEDICAL | 2024-10-01 |
| SYNERGY SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu (P150003/S102) | Boston Scientific Corporation | 2024-10-01 |
| Amplatzer Muscular VSD Occluder (P040040/S047) | ABBOTT MEDICAL | 2024-10-01 |
| LIFEPAK® CR2 Defibrillator (P170018/S020) | Physio-Control, Inc. | 2024-10-01 |
| CapSure Epicardial Pacing Lead (P950024/S111) | Medtronic, Inc. | 2024-10-01 |
| FlexNav and Navitor Loading System, FlexNav Delivery System (P190023/S020) | ABBOTT MEDICAL | 2024-10-01 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S069) | ABBOTT MEDICAL | 2024-10-01 |
| InterStim Therapy System, Verify Evaluation System (P080025/S301) | Medtronic Neuromodulation | 2024-09-30 |
| Navitor Transcatheter Aortic Heart Valves (P190023/S022) | ABBOTT MEDICAL | 2024-09-30 |
| 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/S791) | Medtronic, Inc. | 2024-09-30 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |
| ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/ Confirmatory (P110029/S051) | Abbott Laboratories | 2024-09-30 |
| InterStim Therapy System, Verify Evaluation System (P970004/S406) | Medtronic Neuromodulation | 2024-09-30 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S892) | Medtronic Cardiac Rhythm Disease Management | 2024-09-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S083) | ABBOTT MEDICAL | 2024-09-27 |
| TECNIS® 3-Piece Acrylic Monofocal (P990080/S057) | Johnson & Johnson Surgical Vision, Inc. | 2024-09-27 |
| cobas® CMV (P160041/S046) | Roche Molecular Systems, Inc. | 2024-09-27 |
| Aurora EV-ICD (P220012/S025) | Medtronic, Inc. | 2024-09-27 |
| Amolia MRI CRT-D, Amolia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S858) | Medtronic Cardiac Rhythm Disease Management | 2024-09-27 |
| TECNIS® CL Foldable Silicone IOL (P880081/S048) | Johnson & Johnson Surgical Vision, Inc. | 2024-09-27 |
| TECNIS 1-Piece IOL with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal IOL (P980040/S160) | Johnson & Johnson Surgical Vision, Inc. | 2024-09-27 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S013) | Invivoscribe Technologies, Inc. | 2024-09-27 |
| TECNIS® 3-Piece Multifocal (P080010/S022) | Johnson & Johnson Surgical Vision, Inc. | 2024-09-27 |