| ADVIA Centaur cPSA Readypack Reagents (P990055/S022) | Siemens Healthcare Diagnostics | 2020-08-25 |
| MED-EL Cochlear Implant System (P000025/S116) | Med-El Corp. | 2020-08-25 |
| ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials (P030056/S018) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur HBc IgM Readypack Reagents and Quality Control Material (P030040/S018) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur PSA Readypack Reagents (P950021/S022) | Siemens Healthcare Diagnostics | 2020-08-25 |
| 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/S712) | Medtronic Cardiac Rhythm Disease Management | 2020-08-24 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S446) | Medtronic, Inc. | 2020-08-24 |
| Micra AV TPS and Micra TPS (P150033/S083) | Medtronic, Inc. | 2020-08-24 |
| Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S014) | Euclid Vision Corporation | 2020-08-24 |
| 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/S751) | Medtronic Cardiac Rhythm Disease Management | 2020-08-24 |
| 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/S636) | Medtronic, Inc. | 2020-08-24 |
| HeartStart FRx Defibrillator (P180028/S003) | Philips Medical Systems | 2020-08-22 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S006) | Philips Medical Systems, Inc. | 2020-08-22 |
| WaveLight EX500 Laser (P020050/S035) | Alcon Laboratories, Inc. | 2020-08-21 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S338) | Medtronic, Inc. | 2020-08-21 |
| R3 Biolox delta Ceramic Acetabular System (P150030/S008) | Smith & Nephew, Inc. | 2020-08-21 |
| Activa Deep Brain Stimulation Therapy System (P960009/S377) | Medtronic, Inc. | 2020-08-21 |
| ADEPT Adhesion Reduction Solution (P050011/S008) | Baxter Healthcare Corp | 2020-08-21 |
| WaveLight EX500 Laser (P030008/S031) | Alcon Laboratories, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S008) | Biotronik AG | 2020-08-20 |
| LOTUS Edge Valve System (P180029/S025) | Boston Scientific Corporation | 2020-08-20 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S181) | Boston Scientific Corp | 2020-08-20 |
| Venovo Venous Stent System (P180037/S001) | Bard Peripheral Vascular, Inc. | 2020-08-20 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S011) | Biotronik AG | 2020-08-20 |
| Covera Vascular Covered Stent (P170042/S006) | C.R. Bard, Inc. | 2020-08-20 |
| Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S014) | Djo Global | 2020-08-20 |
| TREO Abdominal Stent-Graft System (P190015/S002) | Bolton Medical, Inc. | 2020-08-20 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S070) | Boston Scientific Corp | 2020-08-20 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S064) | Boston Scientific Corporation | 2020-08-20 |
| Avalus Bioprosthesis (P170006/S017) | Medtronic, Inc. | 2020-08-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S028) | Medinol, Ltd. | 2020-08-20 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S167) | ABBOTT MEDICAL | 2020-08-18 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA (P930027/S023) | Siemens Healthcare Diagnostics, Inc. | 2020-08-18 |
| Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac (P870024/S055) | CooperVision, Inc. | 2020-08-18 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S001) | QIAGEN GmbH | 2020-08-18 |
| Neuroform Atlas Stent System (P180031/S003) | Stryker Neurovascular | 2020-08-18 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S042) | ABBOTT MEDICAL | 2020-08-18 |
| Protégé GPS Self-Expanding Peripheral Stent System (P060001/S030) | Medtronic Vascular, Inc. | 2020-08-18 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000 AFP (P010007/S012) | Siemens Healthcare Diagnostics, Inc. | 2020-08-18 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S063) | ABBOTT MEDICAL | 2020-08-18 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S030) | Medtronic Vascular, Inc. | 2020-08-18 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA (P060005/S011) | Siemens Medical Solutions Diagnostics Limited | 2020-08-18 |
| LOTUS Edge Valve System (P180029/S020) | Boston Scientific Corporation | 2020-08-17 |
| Express SD Renal Premounted Stent System (P060006/S101) | Boston Scientific Corp | 2020-08-17 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S463) | Medtronic Neuromodulation | 2020-08-17 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S022) | KARL STORZ Endoscopy-America, Inc. | 2020-08-17 |
| DuraSeal Exact Spine Sealant System (P080013/S019) | Integra LifeSciences Corporation | 2020-08-17 |
| DuraSeal Dural Sealant System (P040034/S031) | Integra LifeSciences Corporation | 2020-08-17 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S023) | KARL STORZ Endoscopy-America, Inc. | 2020-08-17 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S024) | KARL STORZ Endoscopy-America, Inc. | 2020-08-17 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System (P130021/S076) | Medtronic, Inc. | 2020-08-17 |
| SURGICEL Absorbable Hemostat (N12159/S074) | ETHICON, Inc. | 2020-08-14 |
| MarginProbe System (P110014/S011) | Dilon Medical Technologies, Ltd. | 2020-08-14 |
| Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator (P030039/S024) | Baxter Bio Science | 2020-08-14 |
| CardioMEMS HS System (P100045/S045) | ABBOTT MEDICAL | 2020-08-14 |
| Synergy Ablation System (P100046/S012) | AtriCure, Inc. | 2020-08-14 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S008) | Stryker Leibinger GmbH & Co KG | 2020-08-14 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S038) | Boston Scientific Corp | 2020-08-14 |
| Superion Indirect Decompression System (IDS) (P140004/S019) | Boston Scientific Neuromodulation | 2020-08-14 |
| CINtec PLUS Cytology (P190024/S001) | Ventana Medical Systems, Inc. | 2020-08-14 |
| ETI-AB-EBK PLUS assay (P990041/S030) | DiaSorin, Inc. | 2020-08-13 |
| LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus (P180047/S005) | DiaSorin, Inc. | 2020-08-13 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S021) | Diasorin | 2020-08-13 |
| Nucleus Auditory Brainstem Implant System (P000015/S043) | Cochlear Americas | 2020-08-13 |
| LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers (P180039/S002) | DiaSorin, Inc. | 2020-08-13 |
| Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints (P870024/S054) | CooperVision, Inc. | 2020-08-13 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S019) | Diasorin | 2020-08-13 |
| ETI-AB-COREK PLUS assay (P990045/S028) | DiaSorin, Inc. | 2020-08-13 |
| BioMimics 3D Vascular Stent System (P180003/S003) | Veryan Medical, Ltd. | 2020-08-13 |
| Nucleus 24 Cochlear Implant System (P970051/S199) | Cochlear Americas | 2020-08-13 |
| LIAISON XL Murex Anti-HBc and LIAISON XL Murex Control Anti-HBc (P180038/S003) | DiaSorin, Inc. | 2020-08-13 |
| ETI-CORE-IGMK PLUS assay (P990044/S028) | DiaSorin, Inc. | 2020-08-13 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays (P990038/S031) | DiaSorin, Inc. | 2020-08-13 |
| Arctic Front Cryocatheter System (P100010/S107) | Medtronic Cryocath, LP | 2020-08-13 |
| ETI-EBK PLUS assay (P990043/S031) | DiaSorin, Inc. | 2020-08-13 |
| ETI-AB-AUK PLUS assay (P990042/S027) | DiaSorin, Inc. | 2020-08-13 |
| activL Artifical Disc (P120024/S009) | Highridge Medical, LLC | 2020-08-12 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S036) | Boston Scientific Corp | 2020-08-12 |
| Activa Deep Brain Stimulation Therapy Systems (P960009/S378) | Medtronic, Inc. | 2020-08-12 |
| Rapid fFN for the TLiIQ System (P920048/S017) | Hologic, Inc. | 2020-08-12 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S108) | Abbott Vascular, Inc. | 2020-08-12 |
| ThinPrep Processors and ThinPrep Imaging System (P950039/S039) | Hologic, Inc. | 2020-08-12 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S061) | ABBOTT MEDICAL | 2020-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S439) | Medtronic, Inc. | 2020-08-12 |
| Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Spectra Wave Write (P030017/S340) | Boston Scientific Corp | 2020-08-11 |
| T SPOT-TB Test (P070006/S014) | Oxford Immunotec, Ltd. | 2020-08-11 |
| Micra TPS and Micra AV TPS (P150033/S081) | Medtronic, Inc. | 2020-08-11 |
| Vercise Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S037) | Boston Scientific Corp | 2020-08-11 |
| Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S109) | CooperVision, Inc. | 2020-08-11 |
| Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S111) | CooperVision, Inc. | 2020-08-11 |
| Platinium VR and Platinium DR ICDs (P980049/S138) | MicroPort CRM USA, Inc. | 2020-08-10 |
| Reply SR and Reply DR Pacemakers (P950029/S126) | MicroPort CRM USA, Inc. | 2020-08-10 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P150003/S058) | Boston Scientific Corporation | 2020-08-10 |
| AngioJet Rheolytic Thrombectomy Catheter (P980037/S081) | Boston Scientific Corp | 2020-08-10 |
| Platinium CRT-D and Platinium 4LV CRT-D (P060027/S103) | MicroPort CRM USA, Inc. | 2020-08-10 |
| Floseal Hemostatic Matrix (P990009/S058) | Baxter Healthcare Corp | 2020-08-07 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033) | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S010) | Rxsight, Inc. | 2020-08-07 |
| Guardant360 CDx (P200010) | Guardant Health, Inc. | 2020-08-07 |