| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S033) | Ventana Medical Systems, Inc. | 2020-11-13 |
| PD-L1 IHC 22C3 pharmDX (P150013/S020) | Agilent Technologies, Inc. | 2020-11-13 |
| VENTANA PD-L1 (SP142) Assay (P160002/S013) | Ventana Medical Systems, Inc. | 2020-11-13 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S001) | Ventana Medical Systems, Inc. | 2020-11-13 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S013) | Ventana Medical Systems, Inc. | 2020-11-13 |
| VENTANA PD-L1 (SP263) Assay (P160046/S008) | Ventana Medical Systems, Inc. | 2020-11-13 |
| CINtec PLUS Cytology (P190024/S002) | Ventana Medical Systems, Inc. | 2020-11-13 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S043) | Ventana Medical Systems, Inc. | 2020-11-13 |
| Onyx Liquid Embolic System (P030004/S025) | Ev3 Neurovascular | 2020-11-13 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S319) | Medtronic Neuromodulation | 2020-11-12 |
| Deflux Injectable Gel (P000029/S090) | Palette Life Sciences | 2020-11-12 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S526) | Boston Scientific Corp | 2020-11-12 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S660) | Medtronic, Inc. | 2020-11-12 |
| SENSAR 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1- (P980040/S126) | Johnson & Johnson Surgical Vision, Inc. | 2020-11-12 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S214) | Medtronic Neuromodulation | 2020-11-12 |
| SURGICEL Absorbable Hemostats (N12159/S076) | ETHICON, Inc. | 2020-11-12 |
| InterStim Therapy System, Verify Evaluation System (P970004/S318) | Medtronic Neuromodulation | 2020-11-12 |
| SUPARTZ FX, VISCO-3 (P980044/S054) | Seikagaku Corp. | 2020-11-12 |
| TECNIS Foldable Acrylic IOL (P990080/S054) | Johnson & Johnson Surgical Vision, Inc. | 2020-11-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S002) | Boston Scientific Corporation | 2020-11-12 |
| Solesta Injectable Gel (P100014/S028) | Palette Life Sciences | 2020-11-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S213) | Medtronic Neuromodulation | 2020-11-12 |
| AngioJet Rheolytic Thrombectomy System (P980037/S083) | Boston Scientific Corp | 2020-11-12 |
| Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S007) | Alcon Laboratories, LLC | 2020-11-12 |
| Deep Brain Stimulation Therapy System (P960009/S386) | Medtronic, Inc. | 2020-11-12 |
| Activa Deep Brain Stimulation Therapy System (P960009/S387) | Medtronic, Inc. | 2020-11-12 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S472) | Medtronic Neuromodulation | 2020-11-12 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S457) | Boston Scientific | 2020-11-12 |
| Gel-One (P080020/S039) | Seikagaku Corp. | 2020-11-12 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S718) | Medtronic Cardiac Rhythm Disease Management | 2020-11-11 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S757) | Medtronic Cardiac Rhythm Disease Management | 2020-11-11 |
| Oncomine Dx Target Test (P160045/S023) | Life Technologies Corporation | 2020-11-11 |
| AEGEA Water Vapor Ablation System (P160047/S016) | CooperSurgical, Inc. | 2020-11-10 |
| EDWARDS INTUITY Elite Valve (P150036/S053) | Edwards Lifesciences, LLC | 2020-11-10 |
| PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro (P860057/S200) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S112) | Edwards Lifesciences, LLC | 2020-11-10 |
| SynchroMed Infusion System (P860004/S352) | Medtronic, Inc. | 2020-11-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (Pulmonic) (P200015/S001) | Edwards Lifesciences, LLC | 2020-11-10 |
| LCS Total Knee System (P830055/S258) | Depuy, Inc. | 2020-11-10 |
| Implantable System for Remodulin (ISR) (P140032/S049) | Medtronic, Inc. | 2020-11-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S121) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis (P150048/S050) | Edwards Lifesciences, LLC | 2020-11-10 |
| Arctic Front Advance and Arctic Front Pro Catheters Shaft Components (P100010/S109) | Medtronic Cryocath, LP | 2020-11-09 |
| Exablate 4000 (Neuro) Type 1.0 & 1.1 (P150038/S010) | Insightec | 2020-11-09 |
| LOTUS Edge Valve System (P180029/S028) | Boston Scientific Corporation | 2020-11-06 |
| FoundationOne Liquid CDx (P200016) | Foundation Medicine, Inc. | 2020-11-06 |
| Impella RP (P170011/S028) | Abiomed, Inc. | 2020-11-06 |
| PD-L1 IHC 22C3 PharmDx (P150013/S019) | Agilent Technologies, Inc. | 2020-11-06 |
| Rapid fFN for the TLiIQ System (P920048/S015) | Hologic, Inc. | 2020-11-06 |
| Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S077) | Abiomed, Inc. | 2020-11-06 |
| Restylane Refyne, Restylane Defyne, and Restylane Kysse (P140029/S034) | Q-Med AB | 2020-11-06 |
| Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, Restylane Silk (P040024/S121) | Q-Med AB | 2020-11-06 |
| Home Monitoring System Version 3.48 (P950037/S214) | Biotronik, Inc. | 2020-11-05 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S458) | Boston Scientific | 2020-11-05 |
| Home Monitoring System Version 3.48 (P070008/S117) | Biotronik, Inc. | 2020-11-05 |
| ARCHITECT Free PSA and Alinity i Free PSA (P980007/S043) | Abbott Laboratories | 2020-11-05 |
| Home Monitoring System Version 3.48 (P980023/S102) | Biotronik, Inc. | 2020-11-05 |
| Edwards Commander Delivery System (P200015/S002) | Edwards Lifesciences, LLC | 2020-11-05 |
| Axonics Sacral Neuromodulation System (P190006/S022) | Boston Scientific Corporation | 2020-11-05 |
| ARCHITECT AFP and Alinity i AFP (P120008/S016) | Abbott Laboratories | 2020-11-05 |
| ARCHITECT AUSAB and Alinity i Anti-HBs (P050051/S040) | Abbott Laboratories, Inc. | 2020-11-05 |
| Simplify Cervical Artificial Disc (P200022/S002) | Nuvasive, Inc. | 2020-11-05 |
| ARCHITECT Total PSA and Alinity i Total PSA (P910007/S054) | Abbott Laboratories | 2020-11-05 |
| LifeVest Wearable Defibrillator (P010030/S146) | Zoll Manufacturing Corporation | 2020-11-05 |
| Home Monitoring System Version 3.48 (P000009/S087) | Biotronik, Inc. | 2020-11-05 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S118) | CooperVision, Inc. | 2020-11-05 |
| S-ICD GEN 2 and S-ICD EMBLEM MRI (P110042/S149) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (Bowel) (P180046/S023) | Boston Scientific Corporation | 2020-11-05 |
| Home Monitoring System Version 3.48 (P050023/S150) | Biotronik, Inc. | 2020-11-05 |
| Edwards Commander Delivery System (P140031/S122) | Edwards Lifesciences, LLC | 2020-11-05 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S527) | Boston Scientific Corp | 2020-11-05 |
| Axonics Sacral Neuromodulation System (Urinary) (P190006/S023) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (P180046/S022) | Boston Scientific Corporation | 2020-11-05 |
| InterStim SureScan MRI Leads (P970004/S317) | Medtronic Neuromodulation | 2020-11-04 |
| InterStim SureScan MRI Leads (P080025/S212) | Medtronic Neuromodulation | 2020-11-04 |
| TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S (P980040/S118) | Johnson & Johnson Surgical Vision, Inc. | 2020-11-04 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S038) | ETHICON, Inc. | 2020-11-04 |
| TECNIS Symfony Toric II OptiBlue Extended Range of Vision Intraocular Lenses (P980040/S123) | Johnson & Johnson Surgical Vision, Inc. | 2020-11-03 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S468) | Medtronic Neuromodulation | 2020-11-03 |
| PreVue Preloaded IOL System (P080004/S035) | Hoya Surgical Optics, Inc. | 2020-11-03 |
| InterStim Therapy System, Verify Evaluation System (P970004/S315) | Medtronic Neuromodulation | 2020-11-03 |
| ATTUNE Total Knee System (P830055/S254) | Depuy, Inc. | 2020-11-03 |
| Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis (P990064/S082) | Medtronic, Inc. | 2020-11-03 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S653) | Medtronic, Inc. | 2020-11-03 |
| Activa Deep Brain Stimulation Therapy System (P960009/S382) | Medtronic, Inc. | 2020-11-03 |
| SURGICEL Absorbable Hemostats (N12159/S075) | ETHICON, Inc. | 2020-11-03 |
| InterStim Therapy System, Verify Evaluation System (P080025/S210) | Medtronic Neuromodulation | 2020-11-03 |
| 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, Compia (P010031/S713) | Medtronic Cardiac Rhythm Disease Management | 2020-11-02 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S638) | Medtronic, Inc. | 2020-11-02 |
| MyCareLink Patient Monitor (P890003/S434) | Medtronic, Inc. | 2020-11-02 |
| cobas HBV (P150014/S037) | Roche Molecular Systems, Inc. | 2020-11-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M (P980016/S752) | Medtronic Cardiac Rhythm Disease Management | 2020-11-02 |
| Livewire TC Steerable Electrophysiology Catheter and Safire Bi-directional Ablation Catheter (P960016/S084) | St Jude Medical | 2020-11-02 |
| Consulta CRT-P, Syncra CRT-P, and Viva CRT-P (P010015/S447) | Medtronic, Inc. | 2020-11-02 |
| Therapy Ablation Catheters (P040014/S040) | Irvine Biomedical, Inc. | 2020-11-02 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP and Therap (P110016/S070) | ABBOTT MEDICAL | 2020-11-02 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P040042/S046) | Irvine Biomedical,Inc.(Ibi) | 2020-11-02 |
| TactiCath Quartz Catheter and TactiSys Quartz Equipment (P130026/S062) | St Jude Medical | 2020-11-02 |
| cobas HCV (P150015/S039) | Roche Molecular Systems, Inc. | 2020-11-02 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P060019/S048) | Irvine Biomedical, Inc. | 2020-11-02 |