| Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (P980016/S795) | Medtronic Cardiac Rhythm Disease Management | 2021-11-03 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P180046/S036) | Boston Scientific Corporation | 2021-11-03 |
| Wolverine Coronary Cutting Balloon (P950020/S112) | Boston Scientific Corp | 2021-11-02 |
| Physio-Control LIFEPAK® 20e defibrillator/monitor (P160026/S028) | Physio-Control, Inc. | 2021-11-02 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S038) | Cook Ireland, Ltd. | 2021-11-02 |
| ReSure Sealant (P130004/S011) | Ocular Therapeutix, Inc. | 2021-11-02 |
| DiamondTemp Ablation System (P200028/S002) | Medtronic, Inc. | 2021-11-02 |
| Exoseal® Vascular Closure Device (P100013/S022) | Cordis US Corporation | 2021-11-02 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S022) | Berlin Heart, Inc. | 2021-11-02 |
| Mobi-C® Cervical Disc Prosthesis (two-level use) (P110009/S031) | Highridge Medical, LLC | 2021-11-01 |
| Mobi-C® Cervical Disc Prosthesis (one-level use) (P110002/S031) | Highridge Medical, LLC | 2021-11-01 |
| Elecsys Anti-HBe, PreciControl Anti-HBe (P190005/S001) | Roche Diagnostics | 2021-11-01 |
| Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S (P950037/S230) | Biotronik, Inc. | 2021-10-29 |
| PHYLAX AV ICD SYSTEM (P980023/S109) | Biotronik, Inc. | 2021-10-29 |
| Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro) (P150038/S014) | Insightec | 2021-10-29 |
| Mara Water Vapor Ablation System (P160047/S025) | CooperSurgical, Inc. | 2021-10-29 |
| Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi (P070008/S132) | Biotronik, Inc. | 2021-10-29 |
| Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia (P050023/S163) | Biotronik, Inc. | 2021-10-29 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S045) | ETHICON, Inc. | 2021-10-29 |
| prodisc® C (P070001/S021) | Centinel Spine, LLC | 2021-10-28 |
| Edwards SAPIEN 3 transcatheter heart valve (P140031/S136) | Edwards Lifesciences, LLC | 2021-10-28 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S381) | Medtronic, Inc. | 2021-10-28 |
| HEMOBLAST Bellows (P170012/S026) | Dilon Technologies, Inc. | 2021-10-28 |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S050) | Ferrosan Meidcal Devices A/S | 2021-10-28 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S012) | The Spectranetics Corp. | 2021-10-28 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S010) | The Spectranetics Corp. | 2021-10-28 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S014) | Edwards Lifesciences, LLC | 2021-10-28 |
| Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S115) | Abbott Vascular, Inc. | 2021-10-27 |
| DiamondTemp Ablation System (P200028/S007) | Medtronic, Inc. | 2021-10-27 |
| MemoryGel/MemoryGel Xtra Breast Implants (P030053/S062) | Mentor Corp. | 2021-10-27 |
| SenSight Extension Kit (P960009/S410) | Medtronic, Inc. | 2021-10-27 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S033) | Tiger Aesthetics Medical, LLC | 2021-10-27 |
| Solesta (Injectable Gel) (P100014/S031) | Palette Life Sciences | 2021-10-27 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S693) | Medtronic, Inc. | 2021-10-27 |
| Natrelle Saline Filled Breast Implants (P990074/S045) | Allergan | 2021-10-27 |
| Natrelle Silicone Filled Breast Implants (P020056/S054) | Allergan | 2021-10-27 |
| MemoryShape Breast Implants (P060028/S041) | Mentor Worldwide, LLC | 2021-10-27 |
| Saline-Filled and Spectrum Breast Implants (P990075/S051) | Mentor Worldwide, LLC | 2021-10-27 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse, Restylane Contour (P140029/S042) | Q-Med AB | 2021-10-27 |
| Coseal Surgical Sealant; Coseal Spray Set (P030039/S027) | Baxter Bio Science | 2021-10-27 |
| SYNVISC and SYNVISC ONE (P940015/S047) | Sanofi Genzyme Corp. | 2021-10-27 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S022) | Bimini Health Tech | 2021-10-27 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S002) | Cook Ireland, Ltd. | 2021-10-26 |
| Neuro Cochlear Implant System (P200021/S007) | Oticon Medical | 2021-10-26 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S016) | Abbott Vascular | 2021-10-26 |
| Neuro Cochlear Implant System (P200021/S006) | Oticon Medical | 2021-10-26 |
| Micra AV TPS; Micra TPS (P150033/S121) | Medtronic, Inc. | 2021-10-26 |
| Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti (P840001/S497) | Medtronic Neuromodulation | 2021-10-26 |
| CentriMag Circulatory Support System (P170038/S008) | Abbott | 2021-10-22 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
| RESTYLANE® Injectable Gels (P040024/S124) | Q-Med AB | 2021-10-22 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S184) | W. L. Gore & Associates, Inc. | 2021-10-22 |
| MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW) (P100009/S044) | ABBOTT MEDICAL | 2021-10-22 |
| RHA®4 Dermal Filler (P170002/S019) | Teoxane S.A. | 2021-10-22 |
| RADIESSE (+) Lidocaine Implant (P050052/S132) | Merz North America, Inc. | 2021-10-21 |
| ESSENTIO MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA (P150012/S119) | Boston Scientific | 2021-10-21 |
| SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat , SURGICEL Fibrillar Absorbable Hemostat, (N12159/S087) | ETHICON, Inc. | 2021-10-21 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S104) | Medtronic, Inc. | 2021-10-21 |
| VALITUDE CRT-P; VALITUDE X4 CRT-P (P030005/S214) | Guidant Corp. | 2021-10-21 |
| ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; AUTOGEN CRT-D; MOMENTUM C (P010012/S547) | Boston Scientific Corp | 2021-10-21 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S044) | ETHICON, Inc. | 2021-10-21 |
| ESSENTIO SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE SR; ACCOLADE DR; ACC (N970003/S269) | Boston Scientific Corp | 2021-10-21 |
| EMBLEM S-ICD; EMBLEM MRI S ICD (P110042/S165) | Boston Scientific Corporation | 2021-10-21 |
| Nuvisc, Anikavisc, Ophthalin (P000046/S029) | Anika Therapeutics, Inc. | 2021-10-21 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR,DYNAGEN MINI ICD D (P960040/S472) | Boston Scientific | 2021-10-21 |
| RADIESSE Implant (P050037/S112) | Merz North America, Inc. | 2021-10-21 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S021) | Berlin Heart, Inc. | 2021-10-20 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S114) | ABBOTT MEDICAL | 2021-10-20 |
| Vercise PC, Vercise Gevia and Vercise Genus DBS Systems (P150031/S040) | Boston Scientific Corp | 2021-10-20 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse (P140029/S040) | Q-Med AB | 2021-10-19 |
| Medtronic Evolut Pro+ Transcatheter Delivery Catheter System (P130021/S105) | Medtronic, Inc. | 2021-10-19 |
| EMBLEM S-ICD PG models A209 and A219. (P110042/S160) | Boston Scientific Corporation | 2021-10-19 |
| Attain Ability Lead (P080006/S163) | Medtronic, Inc. | 2021-10-19 |
| CapSure Epicardial Pacing Lead (P950024/S100) | Medtronic, Inc. | 2021-10-19 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S039) | Ferrosan Meidcal Devices A/S | 2021-10-19 |
| PD-L1 IHC 28-8 pharmDx (P150025/S014) | Agilent Technologies, Inc. | 2021-10-18 |
| HeartWare® Ventricular Assist System (P100047/S190) | Medtronic | 2021-10-18 |
| LifeVest Wearable Defibrillator (P010030/S152) | Zoll Manufacturing Corporation | 2021-10-18 |
| OPTIMIZER Smart System (P180036/S010) | Impulse Dynamics (Usa), Inc. | 2021-10-15 |
| Impella 5.5 with SmartAssist (P140003/S086) | Abiomed, Inc. | 2021-10-15 |
| Micra AV TPS; Micra TPS (P150033/S125) | Medtronic, Inc. | 2021-10-15 |
| HeartWare HVAD System (P100047/S189) | Medtronic | 2021-10-15 |
| Spatz3 Adjustable Balloon System (P190012) | Spatz Fgia, Inc. | 2021-10-15 |
| Hintermann Series H3 Total Ankle Replacement System (P160036/S003) | Dt Medtech, LLC | 2021-10-15 |
| VENTANA PD-L1 (SP263) Assay (P160046/S010) | Ventana Medical Systems, Inc. | 2021-10-15 |
| Micra AV TPS; Micra TPS (P150033/S124) | Medtronic, Inc. | 2021-10-14 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S020) | Berlin Heart, Inc. | 2021-10-14 |
| 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/S794) | Medtronic Cardiac Rhythm Disease Management | 2021-10-14 |
| Astron Pulsar Stent System (P160025/S012) | Biotronik AG | 2021-10-14 |
| enVista® hydrophobic acrylic intraocular lens (IOL) (P910056/S048) | Bausch & Lomb, Inc. | 2021-10-14 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S009) | MicroVention, Inc. | 2021-10-14 |
| Ampere Generator (P040042/S051) | Irvine Biomedical,Inc.(Ibi) | 2021-10-14 |
| Ampere Generator (P040014/S045) | Irvine Biomedical, Inc. | 2021-10-14 |
| 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/S759) | Medtronic Cardiac Rhythm Disease Management | 2021-10-14 |
| Ampere Generator (P060019/S054) | Irvine Biomedical, Inc. | 2021-10-14 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S014) | Biotronik AG | 2021-10-14 |
| Ampere Generator (P130026/S076) | St Jude Medical | 2021-10-14 |
| Ampere Generator (P110016/S079) | ABBOTT MEDICAL | 2021-10-14 |
| Ampere Generator (P960016/S088) | St Jude Medical | 2021-10-14 |
| HEMOBLAST Bellows (P170012/S027) | Dilon Technologies, Inc. | 2021-10-13 |