| WOLVERINE Coronary Cutting Balloon® (P950020/S127) | Boston Scientific Corp | 2022-10-17 |
| Deep Brain Stimulation (DBS) System (P140009/S079) | ABBOTT MEDICAL | 2022-10-17 |
| Endurant Stent Graft System, Endurant II Stent Graft System (P100021/S106) | Medtronic Vascular | 2022-10-17 |
| Medtronic MiniMed 670G System, Medtronic MiniMed 770G System (P160017/S102) | Medtronic Minimed, Inc. | 2022-10-17 |
| ROTAWIRE Guidewire (P900056/S202) | Boston Scientific Corp | 2022-10-17 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te (P130013/S050) | Boston Scientific Corp | 2022-10-17 |
| MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S048) | ABBOTT MEDICAL | 2022-10-17 |
| Medtronic MiniMed 630G System with SmartGuard (P150001/S099) | Medtronic Minimed | 2022-10-17 |
| CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application and Patient (P890003/S455) | Medtronic, Inc. | 2022-10-16 |
| Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S723) | Medtronic, Inc. | 2022-10-16 |
| Micra TPS, Micra AV TPS (P150033/S145) | Medtronic, Inc. | 2022-10-16 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S087) | ABBOTT MEDICAL | 2022-10-14 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S487) | Boston Scientific | 2022-10-14 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S049) | ABBOTT MEDICAL | 2022-10-14 |
| IMMULITE® 2000 Anti-HBs (P010052/S016) | Siemens Healthcare Diagnostics Products, Ltd. | 2022-10-14 |
| 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/S803) | Medtronic Cardiac Rhythm Disease Management | 2022-10-14 |
| IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP (P010007/S017) | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
| DUROLANE (P170007/S014) | Bioventus, LLC | 2022-10-14 |
| IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA (P930027/S028) | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P (P010015/S507) | Medtronic, Inc. | 2022-10-14 |
| IMMULITE® 2000 Anti-HBc (P010051/S017) | Siemens Healthcare Diagnostics Products, Ltd. | 2022-10-14 |
| Venous Wallstent and Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S060) | Boston Scientific Corporation | 2022-10-14 |
| IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit (P010050/S021) | Siemens Healthcare Diagnostics Products, Ltd. | 2022-10-14 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C (P110010/S195) | Boston Scientific Corp | 2022-10-14 |
| IMMULITE® 2000 Anti-HBc IgM (P010053/S016) | Siemens Healthcare Diagnostics Products, Ltd. | 2022-10-14 |
| IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA (P060005/S016) | Siemens Medical Solutions Diagnostics Limited | 2022-10-14 |
| Artegraft Collagen Vascular Graft (N16837/S028) | LeMaitre Vascular, Inc. | 2022-10-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro (P980016/S837) | Medtronic Cardiac Rhythm Disease Management | 2022-10-14 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S081) | Zimmer, Inc. | 2022-10-14 |
| GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder (P050006/S101) | W. L. Gore & Associates, Inc. | 2022-10-14 |
| REALIANCE 4-SITE Family of Defibrillation Leads (P910073/S169) | Boston Scientific | 2022-10-14 |
| 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/S563) | Boston Scientific Corp | 2022-10-14 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S107) | Medtronic Vascular | 2022-10-13 |
| EPi-Sense® Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S003) | AtriCure, Inc. | 2022-10-13 |
| Micra Transcatheter Pacing System, Micra AV TPS (P150033/S154) | Medtronic, Inc. | 2022-10-12 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S035) | Abbott Laboratories | 2022-10-12 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S039) | Abbott Laboratories | 2022-10-12 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S037) | Abbott Laboratories | 2022-10-12 |
| ARCHITECT AFP / Alinity i AFP (P120008/S020) | Abbott Laboratories | 2022-10-12 |
| Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application (P130022/S044) | Nevro Corporation | 2022-10-12 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory (P210003/S002) | Abbott Laboratories | 2022-10-12 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S058) | Abbott Laboratories | 2022-10-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S014) | Boston Scientific Corporation | 2022-10-12 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S047) | Abbott Laboratories, Inc. | 2022-10-12 |
| DiamondTemp Ablation System with the EnSite X Mapping System (P200028/S012) | Medtronic, Inc. | 2022-10-12 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S047) | Abbott Laboratories | 2022-10-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S020) | Medtronic Vascular, Inc. | 2022-10-11 |
| Impella RP and Impella RP with SmartAssist (P170011/S046) | Abiomed, Inc. | 2022-10-11 |
| Vibrant Soundbridge System (P990052/S026) | Med-El Elektromedizinische Gerate GmbH | 2022-10-11 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and 3 IN.PACT 018 Paclita (P140010/S068) | Medtronic, Inc. | 2022-10-11 |
| DuraSeal Dural Sealant System (P040034/S035) | Integra LifeSciences Corporation | 2022-10-07 |
| The Spanner Temporary Prostatic Stent (P060010/S013) | Srs Medical | 2022-10-07 |
| SENSAR® 1-piece IOL, TECNIS® 1-Piece IOL, SENSAR® 1-piece IOL with SmartLOADTM Delivery Technology, TECNIS® 1-piece IOL (P980040/S150) | Johnson & Johnson Surgical Vision, Inc. | 2022-10-07 |
| Perceval PLUS Sutureless Heart Valve (P150011/S024) | Corcym S.r.l. | 2022-10-07 |
| DuraSeal Exact Spine Sealant System (P080013/S024) | Integra LifeSciences Corporation | 2022-10-07 |
| LCS® Total Knee System (P830055/S299) | Depuy, Inc. | 2022-10-07 |
| GELSYN-3 (P110005/S012) | Ibsa Institut Biochimique SA | 2022-10-07 |
| Aveir (P150035/S002) | ABBOTT MEDICAL | 2022-10-06 |
| CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application, CareLink Sm (P890003/S456) | Medtronic, Inc. | 2022-10-06 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S082) | Zimmer, Inc. | 2022-10-06 |
| Impella RP, Impella RP with SmartAssist (P170011/S044) | Abiomed, Inc. | 2022-10-06 |
| CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application (P010031/S796) | Medtronic Cardiac Rhythm Disease Management | 2022-10-06 |
| Evoke® SCS System (P190002/S003) | Saluda Medical Pty, Ltd. | 2022-10-06 |
| CareLink SmartSync Evera MRI Application, CareLink SmartSync Visia AF Application (P980016/S830) | Medtronic Cardiac Rhythm Disease Management | 2022-10-06 |
| Sientra Silicone Gel Breast Implants (P070004/S036) | Tiger Aesthetics Medical, LLC | 2022-10-06 |
| NATRELLE Saline-Filled Breast Implants (P020056/S058) | Allergan | 2022-10-05 |
| Conformable GORE® TAG® Conformable Thoracic Stent Graft w/ ACTIVE CONTROL System (CMDS) (P040043/S131) | W. L. Gore & Associates, Inc. | 2022-10-05 |
| GORE® TAG® Thoracic Branch Endoprosthesis (TBE) (P210032/S004) | W. L. Gore & Associates, Inc. | 2022-10-05 |
| ORBERA ® Intragastric Balloon (IGB) System (P140008/S024) | Boston Scientific Corporation | 2022-10-05 |
| NATRELLE Silicone-Filled Breast Implants (P990074/S049) | Allergan | 2022-10-05 |
| GORE® EXCLUDER® AAA Endoprosthesis (AAA) (P020004/S192) | W. L. Gore & Associates, Inc. | 2022-10-05 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S010) | W. L. Gore and Associates, Inc. | 2022-10-05 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S009) | Great Batch Medical | 2022-10-05 |
| LINX Reflux Management System (P100049/S033) | Torax Medical | 2022-10-04 |
| HYALGAN® (P950027/S017) | Fidia Farmaceutici S.P.A. | 2022-10-04 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S439) | Medtronic, Inc. | 2022-10-04 |
| CERAMAX® Ceramic Total Hip System (P070026/S102) | DePuy Orthopaedics, Inc. | 2022-10-04 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol (P130021/S120) | Medtronic, Inc. | 2022-10-04 |
| LCS® Total Knee System (P830055/S296) | Depuy, Inc. | 2022-10-04 |
| LCS® Total Knee System (P830055/S297) | Depuy, Inc. | 2022-10-04 |
| TRILURON® (P180040/S003) | Fidia Farmaceutici S.P.A. | 2022-10-04 |
| RESTYLANE® Family of Injectable Gels (P040024/S133) | Q-Med AB | 2022-10-04 |
| RESTYLANE® Family of Injectable Gels (P140029/S046) | Q-Med AB | 2022-10-04 |
| Impella 5.5 with SmartAssist (P140003/S094) | Abiomed, Inc. | 2022-10-04 |
| Medtronic SelectSecure MRI SureScan Lead (P030036/S139) | Medtronic Cardiac Rhythm Disease Management | 2022-10-03 |
| BIOLON® (P960011/S034) | Altacor , Ltd. | 2022-10-03 |
| Microny family of Pacemakers (P970013/S091) | ABBOTT MEDICAL | 2022-09-30 |
| Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter (P030031/S128) | Biosense Webster, Inc. | 2022-09-30 |
| Celsius FLTRR, EZ Steer Nav DS Catheter (P010068/S070) | Biosense Webster, Inc. | 2022-09-30 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S325) | ABBOTT MEDICAL | 2022-09-30 |
| ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP (P930036/S020) | Siemens Healthcare Diagnostics, Inc. | 2022-09-30 |
| HeartWare HVAD System (P100047/S196) | Medtronic | 2022-09-30 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and (P910023/S447) | ABBOTT MEDICAL | 2022-09-30 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S401) | ABBOTT MEDICAL | 2022-09-30 |
| NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter, (P990025/S070) | Biosense Webster, Inc. | 2022-09-30 |
| Biosense Webster Cables (P990071/S056) | Biosense Webster, Inc. | 2022-09-30 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S046) | Abbott Laboratories, Inc. | 2022-09-30 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S043) | Nevro Corporation | 2022-09-30 |
| RESTYLANE® Injectable Gels (P040024/S134) | Q-Med AB | 2022-09-30 |
| Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St (P950005/S085) | Biosense Webster, Inc. | 2022-09-30 |