| Monovisc High Molecular Weight Hyaluronan (P090031/S011) | Anika Therapeutics, Inc. | 2021-10-13 |
| Life Pulse High Frequency Ventilator (P850064/S045) | Bunnell, Inc. | 2021-10-13 |
| Micra AV TPS; Micra TPS (P150033/S123) | Medtronic, Inc. | 2021-10-13 |
| Belotero Balance + Lidocaine (P090016/S046) | Merz North America, Inc. | 2021-10-13 |
| On-X Ascending Aortic Prosthesis (P000037/S056) | On-X Life Technologies, Inc. | 2021-10-13 |
| Monovisc High Molecular Weight Hyaluronan (P090031/S012) | Anika Therapeutics, Inc. | 2021-10-13 |
| Micra AV TPS, Micra TPS (P150033/S122) | Medtronic, Inc. | 2021-10-13 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S022) | Abbott Vascular, Inc. | 2021-10-12 |
| Ki-67 IHC pharmDx (P210026) | Agilent Technologies, Inc. | 2021-10-12 |
| M6-C Artificial Cervial Disc (P170036/S009) | Spinal Kinetics, LLC | 2021-10-12 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr (P860057/S204) | Edwards Lifesciences, LLC | 2021-10-12 |
| Freezor Cardiac Cryoablation System (P020045/S095) | Medtronic Cryocath, LP | 2021-10-12 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S018) | Celonova Biosciences, Inc. | 2021-10-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve. (P140031/S135) | Edwards Lifesciences, LLC | 2021-10-12 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S062) | Abbott Vascular | 2021-10-12 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis, and t (P150048/S058) | Edwards Lifesciences, LLC | 2021-10-12 |
| LifeVest® Wearable Defibrillator (P010030/S153) | Zoll Manufacturing Corporation | 2021-10-12 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S377) | Medtronic, Inc. | 2021-10-12 |
| Edwards INTUITY Elite Valve (P150036/S058) | Edwards Lifesciences, LLC | 2021-10-12 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S037) | Siemens Healthcare Diagnostics | 2021-10-08 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S007) | MicroVention, Inc. | 2021-10-08 |
| Tack Endovascular System (4F, 1.5-4.5mm) (P190027/S002) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2021-10-08 |
| Nucleus 24 Cochlear Implant System (P970051/S207) | Cochlear Americas | 2021-10-08 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S042) | Siemens Healthcare Diagnostics | 2021-10-08 |
| Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S044) | Boston Scientific Corp | 2021-10-07 |
| Superion Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit (P140004/S026) | Boston Scientific Neuromodulation | 2021-10-07 |
| Innova Self-Expanding Stent System (P140028/S071) | Boston Scientific Corporation | 2021-10-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S047) | Boston Scientific Corp | 2021-10-07 |
| Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (P010012/S528) | Boston Scientific Corp | 2021-10-07 |
| Transcend Hip Articulation System (P010001/S024) | Ceramtec GmbH | 2021-10-07 |
| Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System (P030017/S347) | Boston Scientific Corp | 2021-10-07 |
| Resonate family of CRT-D's (P010012/S540) | Boston Scientific Corp | 2021-10-07 |
| Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators (P960040/S459) | Boston Scientific | 2021-10-07 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S081) | Integra Lifesciences Corp. | 2021-10-07 |
| Powerheart G5 Pediatric Electrodes (P160033/S006) | ZOLL Medical Corporation | 2021-10-07 |
| HeartMate II Left Ventricular Assist System (P060040/S080) | ABBOTT MEDICAL | 2021-10-07 |
| Resonate family of CRT-D's (P960040/S466) | Boston Scientific | 2021-10-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S038) | ABBOTT MEDICAL | 2021-10-07 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S097) | Integra LifeSciences Corporation | 2021-10-07 |
| NexGen® LPS-Flex / LPS-Mobile Bearing Knee System (P060037/S075) | Zimmer, Inc. | 2021-10-07 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S163) | Boston Scientific Corporation | 2021-10-06 |
| SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly (P200040) | Delphinus Medical Technologies | 2021-10-06 |
| Cologuard (P130017/S049) | Exact Sciences Corporation | 2021-10-06 |
| Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defribillator System (P960004/S098) | Boston Scientific | 2021-10-06 |
| Endoktak Lead System (P910073/S167) | Boston Scientific | 2021-10-06 |
| VenaSeal Closure System (P140018/S028) | Medtronic Vascular, Inc. | 2021-10-06 |
| Optimizer Smart System and Optimizer Smart Mini System (P180036/S008) | Impulse Dynamics (Usa), Inc. | 2021-10-06 |
| Contak CD, EasyTrak, Livian, Cognis, and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibril (P010012/S546) | Boston Scientific Corp | 2021-10-06 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S004) | W. L. Gore and Associates, Inc. | 2021-10-06 |
| Guardian Connect System (P160007/S041) | Medtronic Minimed | 2021-10-05 |
| Rotablatorand ROTAPRO Rotational Atherectomy System, RotaWire Guidewire and wireClip Torquer, ROTAWIRE Drive Guidew (P900056/S194) | Boston Scientific Corp | 2021-10-05 |
| CardioMEMS HF System (P100045/S057) | ABBOTT MEDICAL | 2021-10-05 |
| MiniMed 670G System (P160017/S094) | Medtronic Minimed, Inc. | 2021-10-05 |
| Light Adjustable Lens, Light Delivery Device (P160055/S021) | Rxsight, Inc. | 2021-10-05 |
| MiniMed 630G System with SmartGuard Technology (P150001/S092) | Medtronic Minimed | 2021-10-05 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S087) | Boston Scientific | 2021-10-04 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S118) | Boston Scientific | 2021-10-04 |
| Thinline Endocardial Pacing Leads (P960004/S097) | Boston Scientific | 2021-10-04 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System (P150003/S079) | Boston Scientific Corporation | 2021-10-04 |
| Endotak Lead System (P910073/S166) | Boston Scientific | 2021-10-04 |
| GEL-ONE (P080020/S045) | Seikagaku Corp. | 2021-10-04 |
| Sweet Tip (R) Rx Steroid Eluting Lead (P960006/S054) | Boston Scientific | 2021-10-04 |
| LCS Total Knee System (P830055/S275) | Depuy, Inc. | 2021-10-01 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL (P860003/S104) | Therakos Development Limited | 2021-10-01 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S101) | Alcon Research, Ltd. | 2021-10-01 |
| CapSureFix Novus Lead Models 4076 and 5076 (P930039/S232) | Medtronic, Inc. | 2021-10-01 |
| Micra AV TPS, Micra TPS (P150033/S120) | Medtronic, Inc. | 2021-10-01 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S001) | Cook Ireland, Ltd. | 2021-10-01 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S231) | Medtronic, Inc. | 2021-10-01 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA (P860003/S105) | Therakos Development Limited | 2021-10-01 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S027) | Abbott Vascular (Idef Technologies Inc) | 2021-09-30 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S054) | Abbott Diabetes Care, Inc. | 2021-09-30 |
| SURGICEL® SNoW Absorbable Hemostat (N12159/S084) | ETHICON, Inc. | 2021-09-30 |
| Mynx Control Vascular Closure Device (VCD) (P040044/S086) | Cordis US Corporation | 2021-09-29 |
| CareLink SmartSync Cobalt, Crome App (P010031/S750) | Medtronic Cardiac Rhythm Disease Management | 2021-09-29 |
| CORDIS EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S021) | Cordis US Corporation | 2021-09-28 |
| Micra AV TPS, Micra TPS (P150033/S119) | Medtronic, Inc. | 2021-09-28 |
| VENTANA PD-L1 (SP142) Assay (P160002/S015) | Ventana Medical Systems, Inc. | 2021-09-28 |
| Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM (P090022/S039) | Lenstec, Inc. | 2021-09-28 |
| Organ Care System (OCS) Liver (P200031) | TransMedics, Inc. | 2021-09-28 |
| Lotralcon B soft contact lenses (P010019/S080) | Alcon Laboratories, Inc. | 2021-09-28 |
| ISPAN PERFLUOROPROPANE C3F8 GAS (P900066/S013) | Airgas Therapeutics, LLC | 2021-09-28 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S178) | ABBOTT MEDICAL | 2021-09-27 |
| Amplatzer Talisman PFO Occluder (P120021/S020) | ABBOTT MEDICAL | 2021-09-27 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S071) | ABBOTT MEDICAL | 2021-09-27 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S049) | ABBOTT MEDICAL | 2021-09-27 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |
| ACUITY STEERABLE LEAD SYSTEM (P050046/S032) | Guidant Corp. | 2021-09-24 |
| GORE EXCLUDER Iliac Branch Endoprosthesis, GORE EXCLUDER Conformable AAA Endoprothesis (P020004/S182) | W. L. Gore & Associates, Inc. | 2021-09-24 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S758) | Medtronic Cardiac Rhythm Disease Management | 2021-09-24 |
| THINLINE / FINELINE Family of Endocardial Pacing Leads (P960004/S095) | Boston Scientific | 2021-09-24 |
| 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/S692) | Medtronic, Inc. | 2021-09-24 |
| FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP, (P960004/S096) | Boston Scientific | 2021-09-24 |
| S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE (P110042/S162) | Boston Scientific Corporation | 2021-09-24 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD (P980016/S793) | Medtronic Cardiac Rhythm Disease Management | 2021-09-24 |
| SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND (P960006/S053) | Boston Scientific | 2021-09-24 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S059) | Mentor Corp. | 2021-09-24 |
| S-ICD, Q-TRAK Subcutaneous Electrode, Q-TECH Programmer and Related Accessories (P110042/S158) | Boston Scientific Corporation | 2021-09-24 |
| GORE® VIABAHN® Endoprosthesis (P040037/S146) | W. L. Gore & Associates, Inc. | 2021-09-24 |