| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I (P980016/S819) | Medtronic Cardiac Rhythm Disease Management | 2022-05-17 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S189) | ABBOTT MEDICAL | 2022-05-17 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S398) | ABBOTT MEDICAL | 2022-05-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I (P980016/S818) | Medtronic Cardiac Rhythm Disease Management | 2022-05-16 |
| 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/S785) | Medtronic Cardiac Rhythm Disease Management | 2022-05-16 |
| CT Lucia 602, CT Lucia 202, CT Lucia 611P (P100016/S014) | Carl Zeiss Meditec Production, LLC | 2022-05-13 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System (P100021/S104) | Medtronic Vascular | 2022-05-13 |
| Axonics Sacral Neuromodulation System (P190006/S055) | Boston Scientific Corporation | 2022-05-13 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032) | W. L. Gore & Associates, Inc. | 2022-05-13 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S039) | Cook Ireland, Ltd. | 2022-05-13 |
| Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S046) | Nevro Corporation | 2022-05-13 |
| Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C (P840001/S499) | Medtronic Neuromodulation | 2022-05-13 |
| Axonics Sacral Neuromodulation System (P180046/S055) | Boston Scientific Corporation | 2022-05-13 |
| LCS Total Knee System (P830055/S287) | Depuy, Inc. | 2022-05-13 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S426) | Medtronic, Inc. | 2022-05-12 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S055) | Medtronic Vascular | 2022-05-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S257) | Medtronic Neuromodulation | 2022-05-12 |
| Saluda Medical Evoke SCS System (P190002/S006) | Saluda Medical Pty, Ltd. | 2022-05-12 |
| SVS Deployment Catheter and Loader (P180007/S009) | Gyrus Acmi, Inc. | 2022-05-12 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S251) | Medtronic Neuromodulation | 2022-05-12 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S391) | Medtronic, Inc. | 2022-05-12 |
| InterStim Therapy System, Verify Evaluation System (P970004/S362) | Medtronic Neuromodulation | 2022-05-12 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S356) | Medtronic Neuromodulation | 2022-05-12 |
| Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St (P840001/S516) | Medtronic Neuromodulation | 2022-05-12 |
| CapSureFix MRI Lead (P090013/S321) | Medtronic, Inc. | 2022-05-11 |
| CentriMag Circulatory Support System (P170038/S010) | Abbott | 2022-05-11 |
| CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S242) | Medtronic, Inc. | 2022-05-11 |
| 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/S715) | Medtronic, Inc. | 2022-05-10 |
| Paragon Z CRT, Paragon Z CRT Dual Axis (P050031/S009) | CooperVision, Inc. | 2022-05-10 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S425) | Medtronic, Inc. | 2022-05-10 |
| InterStim Therapy System, Verify Evaluation System (P080025/S256) | Medtronic Neuromodulation | 2022-05-10 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S390) | Medtronic, Inc. | 2022-05-10 |
| HeartWare® Ventricular Assist System (P100047/S197) | Medtronic | 2022-05-10 |
| Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an (P870024/S062) | CooperVision, Inc. | 2022-05-10 |
| Optune® device (P100034/S029) | Novocure, GmbH | 2022-05-10 |
| Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St (P840001/S515) | Medtronic Neuromodulation | 2022-05-10 |
| InterStim Therapy System, Verify Evaluation System (P970004/S361) | Medtronic Neuromodulation | 2022-05-10 |
| GORE CARDIOFORM Septal Occluder (P050006/S099) | W. L. Gore & Associates, Inc. | 2022-05-09 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S009) | Xvivo Perfusion, Inc. | 2022-05-09 |
| Aptima CMV Quant Assay (P210029) | Hologic, Inc. | 2022-05-09 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S008) | Xvivo Perfusion, Inc. | 2022-05-09 |
| Rapid fFN for the TLiIQ System (P920048/S023) | Hologic, Inc. | 2022-05-09 |
| HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S014) | Philips Medical Systems, Inc. | 2022-05-09 |
| Organ Care System (OCS) Lung System (P160013/S009) | TransMedics, Inc. | 2022-05-06 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S008) | DiaSorin, Inc. | 2022-05-06 |
| LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc (P180038/S011) | DiaSorin, Inc. | 2022-05-06 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S015) | DiaSorin, Inc. | 2022-05-06 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S010) | DiaSorin, Inc. | 2022-05-06 |
| lnnova Vascular Self-Expanding Stent with Delivery System (P140028/S073) | Boston Scientific Corporation | 2022-05-06 |
| AngioJet Rheolythic Thrombectomy Catheter System (P980037/S088) | Boston Scientific Corp | 2022-05-06 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S049) | Boston Scientific Corp | 2022-05-06 |
| Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) (P050050/S021) | Djo Global | 2022-05-06 |
| Epic Vascular Self-Expanding Stent System (P110035/S067) | Boston Scientific Corp | 2022-05-06 |
| LIAISON® XL MUREX HBeAg and LIAISON00 XL MUREX Control HBeAg (P180048/S008) | DiaSorin, Inc. | 2022-05-06 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S127) | Medtronic Cryocath, LP | 2022-05-06 |
| WATCHMAN FLX Left Atrial Appendage Closure System (P130013/S047) | Boston Scientific Corp | 2022-05-06 |
| LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S005) | DiaSorin, Inc. | 2022-05-06 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S120) | Abbott Vascular | 2022-05-06 |
| FoundationOne CDx (P170019/S032) | Foundation Medicine, Inc. | 2022-05-06 |
| SYNERGY Drug Eluting Coronary Stent System (P150003/S085) | Boston Scientific Corporation | 2022-05-06 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S008) | DiaSorin, Inc. | 2022-05-06 |
| LIAISON® XL MUREX Anti-HBe assay and Control (P180049/S007) | DiaSorin, Inc. | 2022-05-05 |
| LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers (P180039/S009) | DiaSorin, Inc. | 2022-05-05 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S389) | Medtronic, Inc. | 2022-05-05 |
| LIAISON® XL MUREX HBsAg Qual assay and Control (P190017/S004) | DiaSorin, Inc. | 2022-05-05 |
| LIAISON® XL MUREX HBc lgM assay and Control (P180045/S007) | DiaSorin, Inc. | 2022-05-05 |
| Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler (P090016/S048) | Merz North America, Inc. | 2022-05-05 |
| Alinity m CMV (P210022) | Abbott Molecular, Inc. | 2022-05-05 |
| CERAMAX® Ceramic Total Hip System (P070026/S097) | DePuy Orthopaedics, Inc. | 2022-05-05 |
| INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S099) | Integra Lifesciences Corp. | 2022-05-05 |
| LIAISON® QuantiFERON TB-Gold Plus assay and Control (P180047/S014) | DiaSorin, Inc. | 2022-05-05 |
| Philips Laser System (P910001/S115) | Spectranetics Corp. | 2022-05-05 |
| LIAISON® XL MUREX HBeAg assay and Control (P180048/S007) | DiaSorin, Inc. | 2022-05-05 |
| Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa (P180050/S003) | Cvrx, Inc. | 2022-05-05 |
| LIAISON®XL MUREX Anti-HBc assay and Control (P180038/S010) | DiaSorin, Inc. | 2022-05-05 |
| RADIESSE® Injectable Implant, including RADIESSE® Hands, RADIESSE® (+) Lidocaine, and RADIESSE® (+) Jawline (P050052/S135) | Merz North America, Inc. | 2022-05-05 |
| RADIESSE® Injectable Implant (P050037/S114) | Merz North America, Inc. | 2022-05-05 |
| Eversense E3 Continuous Glucose Monitoring System (P160048/S018) | Senseonics, Incorporated | 2022-05-04 |
| Aveir VR Leadless System: Aveir Leadless Pacemaker (Right Ventricular), Aveir Delivery System Catheter, Aveir Link M (P150035/S001) | ABBOTT MEDICAL | 2022-05-04 |
| EVO/EVO+ VISIAN® Implantable Collamer® Lenses (P030016/S043) | STAAR Surgical Company | 2022-05-04 |
| R3 Delta Ceramic Acetabular System (P150030/S020) | Smith & Nephew, Inc. | 2022-05-03 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S782) | Medtronic Cardiac Rhythm Disease Management | 2022-05-03 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S497) | Medtronic, Inc. | 2022-05-03 |
| 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/S714) | Medtronic, Inc. | 2022-05-03 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S815) | Medtronic Cardiac Rhythm Disease Management | 2022-05-03 |
| WOLVERINE Coronary Cutting Balloon (P950020/S122) | Boston Scientific Corp | 2022-05-03 |
| Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact (P080011/S145) | CooperVision, Inc. | 2022-05-03 |
| AccelStimTM Bone Growth Stimulator (P210035) | Orthofix US, LLC | 2022-05-03 |
| ENROUTE Transcarotid Stent System (P140026/S019) | Boston Scientific Corporation | 2022-05-03 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher (P190018/S019) | Alcon Laboratories, LLC | 2022-05-03 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S171) | Medtronic, Inc. | 2022-05-03 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S268) | Medtronic, Inc. | 2022-05-03 |
| Micra AV TPS, Micra TPS (P150033/S138) | Medtronic, Inc. | 2022-05-03 |
| DiamondTemp Ablation System (P200028/S009) | Medtronic, Inc. | 2022-05-02 |
| Enlite Sensor (MMT-7008) (P150019/S065) | Medtronic Minimed | 2022-04-29 |
| LIPOSORBER LA-15 System (P910018/S033) | Kaneka Pharma America Corp. | 2022-04-29 |
| Guardian Sensor (3) (MMT-7020) (P160007/S044) | Medtronic Minimed | 2022-04-29 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol (P130021/S109) | Medtronic, Inc. | 2022-04-29 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S194) | Boston Scientific Corp | 2022-04-29 |
| Nucleus® Hybrid Implant System (P130016/S046) | Cochlear Americas | 2022-04-29 |