| SmartAblate Irrigation Tubing Set (P990071/S055) | Biosense Webster, Inc. | 2023-01-24 |
| RADIESSE® Injectable Implant (P050037/S116) | Merz North America, Inc. | 2023-01-24 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S137) | Merz North America, Inc. | 2023-01-24 |
| Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems (P010032/S189) | ABBOTT MEDICAL | 2023-01-24 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017) | Ortho-Clinical Diagnostics | 2023-01-24 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| COAPTITE Injectable Impant (P040047/S064) | Merz North America, Inc. | 2023-01-24 |
| Spatz3 Adjustable Balloon System (P190012/S003) | Spatz Fgia, Inc. | 2023-01-23 |
| RelayPlus Thoracic Stent-Graft System (P110038/S027) | Bolton Medical, Inc. | 2023-01-20 |
| TREO® Abdominal Stent-Graft System (P190015/S010) | Bolton Medical, Inc. | 2023-01-20 |
| Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters (P050026/S002) | Bausch + Lomb Ireland Limited | 2023-01-20 |
| Pamira ICD Leads (P980023/S113) | Biotronik, Inc. | 2023-01-20 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S053) | Boston Scientific Corp | 2023-01-20 |
| BAROSTIM NEO® System (P180050/S008) | Cvrx, Inc. | 2023-01-20 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S056) | Boston Scientific Corp | 2023-01-20 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S151) | Edwards Lifesciences, LLC | 2023-01-20 |
| Mara Water Vapor Ablation System (P160047/S028) | CooperSurgical, Inc. | 2023-01-19 |
| LifeVest® Wearable Defibrillator (P010030/S163) | Zoll Manufacturing Corporation | 2023-01-19 |
| Arctic Front Advance® Cardiac CryoAblation Catheters (P100010/S134) | Medtronic Cryocath, LP | 2023-01-19 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter (P020045/S102) | Medtronic Cryocath, LP | 2023-01-19 |
| TRILURON® (sodium hyaluronate) (P180040/S004) | Fidia Farmaceutici S.P.A. | 2023-01-19 |
| 9F Freezor MAX Cardiac Cryoablation Catheter (P100010/S135) | Medtronic Cryocath, LP | 2023-01-19 |
| HYALGAN® (sodium hyaluronate) (P950027/S018) | Fidia Farmaceutici S.P.A. | 2023-01-19 |
| Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S153) | CooperVision, Inc. | 2023-01-19 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S028) | Edwards Lifesciences, LLC | 2023-01-19 |
| CareLink SmartSync Micra VR App, CareLink SmartSync Micra AV App (P150033/S162) | Medtronic, Inc. | 2023-01-18 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S134) | Boston Scientific Corp | 2023-01-18 |
| VNS Therapy System (P970003/S237) | LivaNova USA, Inc. | 2023-01-18 |
| LifeVest® Wearable Defibrillator (P010030/S158) | Zoll Manufacturing Corporation | 2023-01-17 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S512) | Medtronic, Inc. | 2023-01-17 |
| FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S052) | Abbott Diabetes Care, Inc. | 2023-01-17 |
| 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/S738) | Medtronic, Inc. | 2023-01-17 |
| Cerene® Cryotherapy Device (P180032/S011) | Channel Medsystems, Inc. | 2023-01-17 |
| RELIANCE 4-FRONT (P910073/S171) | Boston Scientific | 2023-01-16 |
| Sprint Quattro Lead (P920015/S274) | Medtronic, Inc. | 2023-01-16 |
| CapSure Sense Lead (P830061/S211) | Medtronic Cardiac Rhythm Disease Management | 2023-01-16 |
| Protego EP PASSION (P980023/S118) | Biotronik, Inc. | 2023-01-16 |
| Protego EP PASSION (P050023/S170) | Biotronik, Inc. | 2023-01-16 |
| CapSureFix Novus Lead (P930039/S248) | Medtronic, Inc. | 2023-01-16 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S737) | Medtronic, Inc. | 2023-01-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S845) | Medtronic Cardiac Rhythm Disease Management | 2023-01-13 |
| Synvisc, Synvisc-One (P940015/S051) | Sanofi Genzyme Corp. | 2023-01-13 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S015) | CooperVision, Inc. | 2023-01-13 |
| Alinity m HBV Assay (P200013/S012) | Abbott Molecular, Inc. | 2023-01-13 |
| RealTime CMV Assay (P160044/S005) | Abbott Molecular | 2023-01-13 |
| 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, Cobalt (P010031/S811) | Medtronic Cardiac Rhythm Disease Management | 2023-01-13 |
| Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste (P190023/S002) | ABBOTT MEDICAL | 2023-01-13 |
| CARBOMEDICS Prosthetic Heart Valve (CPHV) (P900060/S062) | Corcym S.r.l. | 2023-01-13 |
| Praxis Extended RAS Panel (P160038/S024) | Illumina, Inc. | 2023-01-13 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P050023/S169) | Biotronik, Inc. | 2023-01-12 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P000009/S100) | Biotronik, Inc. | 2023-01-12 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S013) | CooperVision, Inc. | 2023-01-12 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) (P110002/S033) | Highridge Medical, LLC | 2023-01-12 |
| P040047 COAPTITE® Injectable Implant (P040047/S069) | Merz North America, Inc. | 2023-01-12 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) (P110009/S033) | Highridge Medical, LLC | 2023-01-12 |
| DEXCOM G5 Mobile Continuous Glucose Monitoring System (P120005/S090) | Dexcom, Inc. | 2023-01-12 |
| GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S132) | W. L. Gore & Associates, Inc. | 2023-01-12 |
| Light Adjustable Lens, Light Delivery Device (P160055/S025) | Rxsight, Inc. | 2023-01-12 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P070008/S143) | Biotronik, Inc. | 2023-01-12 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S142) | Merz North America, Inc. | 2023-01-12 |
| PSW 2202.U and NEO 2202.U (P950037/S242) | Biotronik, Inc. | 2023-01-12 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |
| RADIESSE® Injectable Implant (P050037/S121) | Merz North America, Inc. | 2023-01-12 |
| VIRTIS SACRAL NEUROMODULATION SYSTEM (P170001) | Cirtec Medical Corporation | 2023-01-11 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S014) | CooperVision, Inc. | 2023-01-10 |
| LIFEPAK® CR2 Defibrillator (P170018/S015) | Physio-Control, Inc. | 2023-01-10 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S006) | Kestra Medical Technologies, Inc. | 2023-01-10 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S050) | ABBOTT MEDICAL | 2023-01-10 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S089) | ABBOTT MEDICAL | 2023-01-10 |
| Impella2.5, ImpellaCP, Impella CP with SmartAssist (P140003/S106) | Abiomed, Inc. | 2023-01-06 |
| COAPTITE® Injectable Implant (P040047/S065) | Merz North America, Inc. | 2023-01-06 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S054) | Boston Scientific Corp | 2023-01-06 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S356) | Boston Scientific Corp | 2023-01-06 |
| CardioMEMS HF System (P100045/S064) | ABBOTT MEDICAL | 2023-01-06 |
| Superion Indirect Decompression System (P140004/S029) | Boston Scientific Neuromodulation | 2023-01-06 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S138) | Merz North America, Inc. | 2023-01-06 |
| RADIESSE® Injectable Implant (P050037/S117) | Merz North America, Inc. | 2023-01-06 |
| Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant (P130014/S016) | Stryker Leibinger GmbH & Co KG | 2023-01-05 |
| CT LUCIA Intraocular Lens (IOL) (P100016/S015) | Carl Zeiss Meditec Production, LLC | 2023-01-05 |
| Gel-One (P080020/S051) | Seikagaku Corp. | 2023-01-05 |
| Plasmaflo OP-05W(A) (P820033/S016) | Asahi Kasei Medical Co., Ltd. | 2023-01-05 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp (P030017/S359) | Boston Scientific Corp | 2023-01-04 |
| 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/S736) | Medtronic, Inc. | 2023-01-04 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S037) | Physio-Control, Inc. | 2023-01-04 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S016) | Tiger Aesthetics Medical, LLC | 2023-01-03 |