| Obalon Balloon System (P160001/S047) | Medtimo, Inc. | 2022-07-18 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S124) | Boston Scientific Corp | 2022-07-18 |
| Micra Transcatheter Pacemaker System (P150033/S098) | Medtronic, Inc. | 2022-07-15 |
| Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S019) | The Spectranetics Corp. | 2022-07-15 |
| Talent Occluder With Occluder Delivery System (P100021/S089) | Medtronic Vascular | 2022-07-15 |
| Micra AV TPS, Micra TPS (P150033/S144) | Medtronic, Inc. | 2022-07-15 |
| EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P (P130021/S088) | Medtronic, Inc. | 2022-07-15 |
| eCoin (Electroceutical Coin) (P200036/S003) | Boston Scientific Corporation | 2022-07-15 |
| Integrity Coronary Stent Systems (P030009/S101) | Medtronic, Ireland | 2022-07-15 |
| Resolute Integrity Coronary Stent System (P110013/S109) | Medtronic Vascular | 2022-07-15 |
| Resolute Onyx Coronary Stent Systems (P160043/S045) | Medtronic Vascular | 2022-07-15 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S007) | Xvivo Perfusion, Inc. | 2022-07-14 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S116) | Abbott Vascular, Inc. | 2022-07-14 |
| Assurity MRI, Endurity MRI, and Zenus MRI (P140033/S073) | ABBOTT MEDICAL | 2022-07-14 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR (P910023/S446) | ABBOTT MEDICAL | 2022-07-14 |
| Avant HF, Neutrino NxT HF, Gallant HF, and Entrant HF (P030054/S399) | ABBOTT MEDICAL | 2022-07-14 |
| Allure Quadra (P030035/S190) | ABBOTT MEDICAL | 2022-07-14 |
| CT Lucia 602 (P100016/S011) | Carl Zeiss Meditec Production, LLC | 2022-07-14 |
| Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus (P880086/S324) | ABBOTT MEDICAL | 2022-07-14 |
| Saluda Medical Evoke® SCS System (P190002/S007) | Saluda Medical Pty, Ltd. | 2022-07-14 |
| Oxford Partial Knee System (P010014/S102) | Biomet Manufacturing Corp | 2022-07-14 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S013) | Anika Therapeutics, Inc. | 2022-07-13 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S123) | Boston Scientific Corp | 2022-07-13 |
| XACT Carotid Stent System (P040038/S040) | Abbott Vascular, Inc. | 2022-07-13 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S126) | Boston Scientific | 2022-07-13 |
| PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT (N970003/S273) | Boston Scientific Corp | 2022-07-13 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR (P960040/S479) | Boston Scientific | 2022-07-13 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S218) | Guidant Corp. | 2022-07-13 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR (P010012/S555) | Boston Scientific Corp | 2022-07-13 |
| SICD Gen 2 A209, SICD MRI A219 (P110042/S171) | Boston Scientific Corporation | 2022-07-13 |
| CERAMAX® Ceramic Total Hip System (P070026/S100) | DePuy Orthopaedics, Inc. | 2022-07-12 |
| NMP22 BladderChek Test (P940035/S017) | Abbott Diagnostics Scarborough, Inc. | 2022-07-12 |
| Prometra Programmable Infusion Pump System (P080012/S070) | Infusyn Therapeutics, LLC | 2022-07-12 |
| therascreen KRAS RGQ PCR Kit (P110027/S015) | QIAGEN GmbH | 2022-07-11 |
| BD FocalPoint GS Imaging System (P950009/S026) | Bd Diagnostics | 2022-07-11 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S019) | Medtronic Vascular, Inc. | 2022-07-08 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist (P140003/S098) | Abiomed, Inc. | 2022-07-08 |
| InterStim Therapy System (SNS Bowel Neurostimulator) (P080025/S264) | Medtronic Neuromodulation | 2022-07-08 |
| LIAISON® QuantiFERON TB-Gold Plus assay and Control (P180047/S017) | DiaSorin, Inc. | 2022-07-08 |
| Gynecare Interceed Absorbable Adhesion Barrier (P880047/S050) | ETHICON, Inc. | 2022-07-08 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S001) | W. L. Gore & Associates, Inc. | 2022-07-08 |
| SURGICELTM Family of Absorbable Hemostats (N12159/S094) | ETHICON, Inc. | 2022-07-08 |
| InterStim Therapy System (SNS Urinary Neurostimulator) (P970004/S369) | Medtronic Neuromodulation | 2022-07-08 |
| FoundationOne CDx (F1CDx) (P170019/S035) | Foundation Medicine, Inc. | 2022-07-08 |
| Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S096) | Abiomed, Inc. | 2022-07-08 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut Pro System, Medtronic Evolut Pro+ System, Medtronic Evol (P130021/S115) | Medtronic, Inc. | 2022-07-08 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S066) | Medtronic, Inc. | 2022-07-08 |
| Portico Transcatheter Aortic Heart Valve (P190023/S008) | ABBOTT MEDICAL | 2022-07-07 |
| OrganOx metra System (P200035/S003) | Organox Limited | 2022-07-07 |
| Cologuard® (P130017/S052) | Exact Sciences Corporation | 2022-07-07 |
| GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S091) | W. L. Gore & Associates, Inc. | 2022-07-07 |
| Medtronic EnVeo R Delivery Catheter System, Medtronic EnVeo PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery (P130021/S118) | Medtronic, Inc. | 2022-07-07 |
| prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo (P070001/S019) | Centinel Spine, LLC | 2022-07-07 |
| LCS Total Knee System (P830055/S292) | Depuy, Inc. | 2022-07-06 |
| GORE CARDIOFORM Septal Occluder (P050006/S100) | W. L. Gore & Associates, Inc. | 2022-07-06 |
| CollaCote, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S086) | Integra Lifesciences Corp. | 2022-07-06 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment (P000053/S126) | Boston Scientific Corp | 2022-07-06 |
| Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S103) | Integra LifeSciences Corporation | 2022-07-06 |
| Lotrafilcon A and B Soft Contact Lenses (P010019/S083) | Alcon Laboratories, Inc. | 2022-07-06 |
| Edwards Alterra Adaptive Prestent System (P200015/S022) | Edwards Lifesciences, LLC | 2022-07-06 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S100) | Integra LifeSciences Corporation | 2022-07-06 |
| LCS Total Knee System (P830055/S277) | Depuy, Inc. | 2022-07-06 |
| Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene (P900033/S101) | Integra Lifesciences Corp. | 2022-07-06 |
| Saluda Medical Evoke SCS System (P190002/S005) | Saluda Medical Pty, Ltd. | 2022-07-06 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S035) | W. L. Gore & Associates, Inc. | 2022-07-05 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S023) | Rxsight, Inc. | 2022-07-05 |
| Praxis Extended RAS Panel (P160038/S022) | Illumina, Inc. | 2022-07-05 |
| Reflection Ceramic Acetabular Hip System (P030022/S048) | Smith & Nephew, Inc. | 2022-07-05 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S035) | Tiger Aesthetics Medical, LLC | 2022-07-05 |
| Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist (P170011/S042) | Abiomed, Inc. | 2022-07-01 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S049) | Boston Scientific Corp | 2022-07-01 |
| Inspire Upper Airway Stimulation (UAS) (P130008/S076) | Inspire Medical Systems | 2022-07-01 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S101) | Abiomed, Inc. | 2022-07-01 |
| INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template (P900033/S102) | Integra Lifesciences Corp. | 2022-07-01 |
| M6-C Artificial Cervical Disc (P170036/S011) | Spinal Kinetics, LLC | 2022-07-01 |
| LIPOSORBER LA-15 System (P910018/S034) | Kaneka Pharma America Corp. | 2022-06-30 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S078) | ABBOTT MEDICAL | 2022-06-30 |
| Micra AV TPS, Micra TPS (P150033/S143) | Medtronic, Inc. | 2022-06-30 |
| 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/S816) | Medtronic Cardiac Rhythm Disease Management | 2022-06-29 |
| 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/S783) | Medtronic Cardiac Rhythm Disease Management | 2022-06-29 |
| LCS Total Knee System (P830055/S289) | Depuy, Inc. | 2022-06-29 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S188) | ABBOTT MEDICAL | 2022-06-28 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S059) | Boston Scientific Corporation | 2022-06-28 |
| Alinity m HBV assay (P200013/S007) | Abbott Molecular, Inc. | 2022-06-28 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S060) | Boston Scientific Scimed, Inc. | 2022-06-28 |
| 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/S792) | Medtronic Cardiac Rhythm Disease Management | 2022-06-28 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S069) | Boston Scientific Corp | 2022-06-28 |
| 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/S826) | Medtronic Cardiac Rhythm Disease Management | 2022-06-28 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X (P170013/S009) | MicroVention, Inc. | 2022-06-28 |
| HeartWare Ventricular Assist System (P100047/S201) | Medtronic | 2022-06-28 |
| LungFit PH (P200044) | Beyond Air, Inc. | 2022-06-28 |
| Guardant360 CDx (P200010/S006) | Guardant Health, Inc. | 2022-06-27 |
| MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD) (P040044/S092) | Cordis US Corporation | 2022-06-27 |
| Sculptra, Sculptra Aesthetic (P030050/S037) | Q-Med AB | 2022-06-27 |
| Barostim System (P180050/S007) | Cvrx, Inc. | 2022-06-27 |
| ENROUTE® Transcarotid Stent System (P140026/S021) | Boston Scientific Corporation | 2022-06-24 |
| Propel Contour Sinus Implant (P100044/S049) | Intersect Ent. | 2022-06-24 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| activL Artificial Disc (P120024/S012) | Highridge Medical, LLC | 2022-06-24 |
| HeartWare Ventricular Assist System (P100047/S199) | Medtronic | 2022-06-24 |