| SURGICEL® ORIGINAL, SURGICEL® NU-KNIT, SURGICEL® FIBRILLAR, SURGICEL® SNOW (N12159/S110) | ETHICON, Inc. | 2024-05-16 |
| SynchroMed Infusion Systems (P860004/S426) | Medtronic, Inc. | 2024-05-16 |
| Deep Brain Stimulation (DBS) External Pulse Generator (EPG), Infinity DBS EPG Base (P140009/S097) | ABBOTT MEDICAL | 2024-05-16 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S059) | ETHICON, Inc. | 2024-05-16 |
| Biofinity Sphere (comfilcon A), Biofinity Torie (comfilcon A), Biofinity XR Torie (comfilcon A), Biofinity Torie Multifo (P080011/S159) | CooperVision, Inc. | 2024-05-16 |
| Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Proclaim SCS EPG Base (P010032/S215) | ABBOTT MEDICAL | 2024-05-16 |
| Alternative Active Anchor (part number 104504) (P190002/S027) | Saluda Medical Pty, Ltd. | 2024-05-16 |
| LifeVest Wearable Defibrillator (P010030/S177) | Zoll Manufacturing Corporation | 2024-05-16 |
| Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base (P150004/S072) | ABBOTT MEDICAL | 2024-05-16 |
| Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit (P140023/S030) | Roche Molecular Systems, Inc. | 2024-05-15 |
| ReShape Lap-Band Adjustable Gastric Banding System (P000008/S050) | Medtimo, Inc. | 2024-05-15 |
| Biomedics 55 Asphere (P890023/S050) | The Cooper Companies | 2024-05-15 |
| Atelica IM Prostate-Specific Antigen (PSA) (P950021/S026) | Siemens Healthcare Diagnostics | 2024-05-15 |
| Lotrafilcon A and B soft Contact Lenses (P010019/S085) | Alcon Laboratories, Inc. | 2024-05-15 |
| GORE TAG Conformable Thoracic Stent Graft with Active Control System (P040043/S136) | W. L. Gore & Associates, Inc. | 2024-05-15 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S011) | Kestra Medical Technologies, Inc. | 2024-05-14 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S068) | Boston Scientific Corp | 2024-05-14 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |
| Entrant VR ICD, Entrant DR ICD, Gallant VR ICD, Gallant DR ICD Neutrino NxT VR ICD, Neutrino NxT DR ICD (P910023/S465) | ABBOTT MEDICAL | 2024-05-14 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S079) | ABBOTT MEDICAL | 2024-05-14 |
| cobas HPV Test (P100020/S055) | Roche Molecular Systems, Inc. | 2024-05-14 |
| SURGICEL® Absorbable Hemostats (SURGICEL POWDER) (N12159/S111) | ETHICON, Inc. | 2024-05-14 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| cobas HPV (P190028/S009) | Roche Molecular Systems, Inc. | 2024-05-14 |
| Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-D (P030054/S420) | ABBOTT MEDICAL | 2024-05-14 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC (P110033/S084) | Allergan | 2024-05-14 |
| RADIESSE Injectable Implant, RADIESSE Hands, RADIESSE® (+) Lidocaine, RADIESSE (+) Jawline (P050052/S159) | Merz North America, Inc. | 2024-05-13 |
| RADIESSE Injectable Implant (P050037/S137) | Merz North America, Inc. | 2024-05-13 |
| CardioMEMS HF System (P100045/S075) | ABBOTT MEDICAL | 2024-05-13 |
| CardioMEMS HF System (P100045/S073) | ABBOTT MEDICAL | 2024-05-13 |
| Zephyr Endobronchial Valve System (P180002/S027) | Pulmonx Corporation | 2024-05-13 |
| RADIESSE® Injectable Implant (P050037/S138) | Merz North America, Inc. | 2024-05-10 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| BioMimics 3D® Vascular Stent (P180003/S009) | Veryan Medical, Ltd. | 2024-05-10 |
| Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C (P030016/S046) | STAAR Surgical Company | 2024-05-10 |
| InterStim Therapy System, Verify Evaluation System (P970004/S399) | Medtronic Neuromodulation | 2024-05-10 |
| Coaptite Injectable Implant (P040047/S074) | Merz North America, Inc. | 2024-05-10 |
| InterStim Therapy System, Verify Evaluation System (P080025/S294) | Medtronic Neuromodulation | 2024-05-10 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S160) | Merz North America, Inc. | 2024-05-10 |
| TriClip G4 Clip Delivery System (P230007/S001) | ABBOTT MEDICAL | 2024-05-09 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S847) | Medtronic Cardiac Rhythm Disease Management | 2024-05-09 |
| 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/S881) | Medtronic Cardiac Rhythm Disease Management | 2024-05-09 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves (P140031/S173) | Edwards Lifesciences, LLC | 2024-05-09 |
| Aurora EV ICD (P220012/S014) | Medtronic, Inc. | 2024-05-09 |
| Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF T QP, Rivacor 5 HF T (P050023/S180) | Biotronik, Inc. | 2024-05-09 |
| Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T, Rivacor 3 DR-T (P000009/S107) | Biotronik, Inc. | 2024-05-09 |
| 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 D (P980023/S124) | Biotronik, Inc. | 2024-05-09 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf (P100021/S121) | Medtronic Vascular | 2024-05-08 |
| Juvéderm Injectable Gel Implants (Ultra, Ultra XC, Ultra Plus XC) (P050047/S094) | Allergan | 2024-05-08 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S033) | Biotronik AG | 2024-05-08 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S029) | Medtronic Vascular, Inc. | 2024-05-08 |
| Resolute Onyx Rapid Exchange Zotarolimus Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolim (P160043/S081) | Medtronic Vascular | 2024-05-08 |
| Harmony Delivery Catheter System (P200046/S033) | Medtronic, Inc. | 2024-05-08 |
| VenaSeal Closure System (P140018/S042) | Medtronic Vascular, Inc. | 2024-05-08 |
| Micra TPS, Micra VR TPS, Micra AV TPS (P150033/S188) | Medtronic, Inc. | 2024-05-08 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010/S080) | Medtronic, Inc. | 2024-05-08 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S030) | Boston Scientific Corporation | 2024-05-08 |
| Aptima HBV Quant Assay (P170025/S021) | Hologic, Inc. | 2024-05-08 |
| Symplicity Spyral' Multi-Electrode Renal Denervation Catheter (P220026/S007) | Medtronic, Inc. | 2024-05-08 |
| Valiant Thoracic Stent Graft System (FreeFlo Tapers Line Extention) with Captivia Delivery System, Valiant Thoracic Sten (P100040/S063) | Medtronic Vascular | 2024-05-08 |
| Nucleus 24 Cochlear Implant System (P970051/S220) | Cochlear Americas | 2024-05-08 |
| Juvéderm Injectable Gel Implants (Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive) (P110033/S083) | Allergan | 2024-05-08 |
| PerClot® Polysaccharide Hemostatic System (P210036/S001) | Baxter Healthcare Corporation | 2024-05-08 |
| Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler (P090016/S059) | Merz North America, Inc. | 2024-05-08 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Sys (P130021/S163) | Medtronic, Inc. | 2024-05-08 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S537) | Medtronic, Inc. | 2024-05-07 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt (P130021/S162) | Medtronic, Inc. | 2024-05-07 |
| Advisa DR IPG, Advisa DR MRl IPG, Advisa SR MRl IPG, Astra S DR MRl IPG, Astra S SR MRl IPG, Astra XT DR MRl IPG, Astra (P980035/S780) | Medtronic, Inc. | 2024-05-07 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S046) | Medtronic Vascular, Inc. | 2024-05-03 |
| LifeVest Wearable Defibrillator Model 5100 (P010030/S176) | Zoll Manufacturing Corporation | 2024-05-03 |
| TREO® Abdominal Stent-Graft System (P190015/S018) | Bolton Medical, Inc. | 2024-05-03 |
| ColoSense® (P230001) | Geneoscopy, Inc. | 2024-05-03 |
| FARAPULSE Pulsed Field Ablation System (P230030/S004) | Farapulse, Inc. | 2024-05-03 |
| EverFlex Self-Expanding Peripheral Stent System, 2 EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Sys (P110023/S045) | Medtronic Vascular, Inc. | 2024-05-02 |
| Artegraft Collagen Vascular Graft (N16837/S033) | LeMaitre Vascular, Inc. | 2024-05-02 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S158) | Merz North America, Inc. | 2024-05-02 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 (P950037/S256) | Biotronik, Inc. | 2024-05-02 |
| SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Kit with Thrombin (P990004/S066) | Ferrosan Meidcal Devices A/S | 2024-05-02 |
| RADIESSE® Injectable Implant (P050037/S136) | Merz North America, Inc. | 2024-05-02 |
| HeartMate 3 Left Ventricular Assist System (P160054/S078) | ABBOTT MEDICAL | 2024-05-02 |
| Axonics Sacral Neuromodulation System (P180046/S083) | Boston Scientific Corporation | 2024-05-02 |
| JUVÉDERM® VOLUMA ® XC (P110033/S079) | Allergan | 2024-05-02 |
| Axonics Sacral Neuromodulation System (P190006/S083) | Boston Scientific Corporation | 2024-05-02 |
| DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S042) | Cardiovascular Systems, Inc. | 2024-05-02 |
| Epsila EV Extravascular Lead (P220012/S024) | Medtronic, Inc. | 2024-05-02 |
| Liberta RC DBS IPG (P140009/S092) | ABBOTT MEDICAL | 2024-05-02 |
| Eterna SCS IPG (P010032/S210) | ABBOTT MEDICAL | 2024-05-02 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S002) | Medtronic, Inc. | 2024-05-01 |
| Avant, Gallant, Entrant, Neutrino NxT Family of ICDs (P910023/S464) | ABBOTT MEDICAL | 2024-05-01 |
| Revanesse Lips+ with Lidocaine 1.2 mL (P160042/S023) | Prollenium Medical Technologies, Inc. | 2024-05-01 |
| Prestige LP (R) Cervical Disc (P090029/S020) | Medtronic Sofamor Danek USA, Inc. | 2024-05-01 |
| Avant, Gallant, Entrant, Neutrino NxT Family of CRT-Ds (P030054/S419) | ABBOTT MEDICAL | 2024-05-01 |
| Assurity MRI, Endurity MRI, Zenus MRI and Zenex MRI Family of Pacemakers (P140033/S088) | ABBOTT MEDICAL | 2024-05-01 |
| Saluda Medical Evoke® SCS System; Implantable Pulse Generator (Model 3042) (P190002/S025) | Saluda Medical Pty, Ltd. | 2024-05-01 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP family of CRT-Ps (P030035/S201) | ABBOTT MEDICAL | 2024-05-01 |
| Aveir VR Delivery Catheter and Aveir DR Delivery Catheter (P150035/S010) | ABBOTT MEDICAL | 2024-05-01 |
| SURGICEL® Absorbable Hemostats (N12159/S109) | ETHICON, Inc. | 2024-05-01 |
| CentriMag Circulatory Support System (P170038/S016) | Abbott | 2024-05-01 |