| Deep Brain Stimulation (DBS) System (P140009/S073) | ABBOTT MEDICAL | 2021-12-30 |
| Spinal Cord Stimulation (SCS) System (P010032/S180) | ABBOTT MEDICAL | 2021-12-30 |
| Dorsal Root Ganglion (DRG) System (P150004/S053) | ABBOTT MEDICAL | 2021-12-30 |
| Subcutaneous Implantable Cardiac Defibrillators, Emblem MRI S-ICD, Emblem S-ICD (P110042/S166) | Boston Scientific Corporation | 2021-12-29 |
| Axonics Sacral Neuromodulation System (P190006/S045) | Boston Scientific Corporation | 2021-12-28 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (P190018/S017) | Alcon Laboratories, LLC | 2021-12-28 |
| iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System (P080004/S043) | Hoya Surgical Optics, Inc. | 2021-12-28 |
| Axonics Sacral Neuromodulation System (P180046/S045) | Boston Scientific Corporation | 2021-12-28 |
| LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe (P180049/S005) | DiaSorin, Inc. | 2021-12-27 |
| LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg (P180048/S005) | DiaSorin, Inc. | 2021-12-27 |
| LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc (P180038/S008) | DiaSorin, Inc. | 2021-12-27 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S007) | DiaSorin, Inc. | 2021-12-27 |
| Pipeline Flex Embolization Device, Pipeline Flex Embolization Device with Shield Technology (P100018/S036) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-12-27 |
| LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM (P180045/S005) | DiaSorin, Inc. | 2021-12-27 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S117) | Vistakon, Division of Johnson & Johnson Vision Car | 2021-12-23 |
| SmartAblate Irrigation Tubing Set (P990071/S047) | Biosense Webster, Inc. | 2021-12-23 |
| AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter) (P050018/S030) | Spectranetics Corp. | 2021-12-23 |
| Innova Vascular Self-Expanding Stent System (P140028/S070) | Boston Scientific Corporation | 2021-12-23 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S046) | Boston Scientific Corp | 2021-12-23 |
| U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S216) | Guidant Corp. | 2021-12-23 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D (N970003/S271) | Boston Scientific Corp | 2021-12-23 |
| TECNIS Symfony OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN (P980040/S142) | Johnson & Johnson Surgical Vision, Inc. | 2021-12-23 |
| RELIANCE 4-FRONT (P910073/S165) | Boston Scientific | 2021-12-23 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, (P150012/S121) | Boston Scientific | 2021-12-23 |
| AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder (P120021/S023) | ABBOTT MEDICAL | 2021-12-22 |
| DUROLANE (P170007/S010) | Bioventus, LLC | 2021-12-22 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S016) | Alcon Laboratories, LLC | 2021-12-22 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos (P950037/S231) | Biotronik, Inc. | 2021-12-22 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S060) | Coloplast Corp. | 2021-12-22 |
| RHA® Redensity (P170002/S012) | Teoxane S.A. | 2021-12-22 |
| Ophthalin, Anikavisc, Nuvisc (P000046/S030) | Anika Therapeutics, Inc. | 2021-12-22 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S133) | Biotronik, Inc. | 2021-12-22 |
| ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (P140016/S004) | Cook Medical Incorporated | 2021-12-22 |
| Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery (P190018/S015) | Alcon Laboratories, LLC | 2021-12-21 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI (P960040/S474) | Boston Scientific | 2021-12-21 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S801) | Medtronic Cardiac Rhythm Disease Management | 2021-12-21 |
| ETI-AB-EBK PLUS assay (P990041/S031) | DiaSorin, Inc. | 2021-12-21 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S020) | Diasorin | 2021-12-21 |
| ETI-AB-COREK PLUS assay (P990045/S029) | DiaSorin, Inc. | 2021-12-21 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S004) | DiaSorin, Inc. | 2021-12-21 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S004) | DiaSorin, Inc. | 2021-12-21 |
| ETI-EBK PLUS assay (P990043/S032) | DiaSorin, Inc. | 2021-12-21 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay (P990038/S032) | DiaSorin, Inc. | 2021-12-21 |
| ETI-AB-AUK PLUS assay (P990042/S028) | DiaSorin, Inc. | 2021-12-21 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S004) | DiaSorin, Inc. | 2021-12-21 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN (P010012/S549) | Boston Scientific Corp | 2021-12-21 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S022) | Diasorin | 2021-12-21 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR (N970003/S272) | Boston Scientific Corp | 2021-12-21 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D, (P010031/S767) | Medtronic Cardiac Rhythm Disease Management | 2021-12-21 |
| BD Totalys MultiProcessor (P970018/S039) | Bd Diagnostic Systems | 2021-12-21 |
| SICD Gen 2, SICD MRI (P110042/S168) | Boston Scientific Corporation | 2021-12-21 |
| SynchroMed® Infusion System (P860004/S380) | Medtronic, Inc. | 2021-12-21 |
| Scoreflex NC Scoring PTCA Catheter (P200041) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-12-21 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S217) | Guidant Corp. | 2021-12-21 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S089) | Dexcom, Inc. | 2021-12-21 |
| LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc (P180038/S007) | DiaSorin, Inc. | 2021-12-21 |
| AcrySof IQ Aspheric IOL with UltraSert (P930014/S140) | Alcon Laboratories, Inc. | 2021-12-21 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S122) | Boston Scientific | 2021-12-21 |
| ORBERA® Intragastric Balloon (IGB) System (P140008/S023) | Boston Scientific Corporation | 2021-12-21 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S006) | DiaSorin, Inc. | 2021-12-21 |
| GORE CARDIOFORM Septal Occluder (P050006/S093) | W. L. Gore & Associates, Inc. | 2021-12-21 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON® - TB Gold Plus (P180047/S012) | DiaSorin, Inc. | 2021-12-21 |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect (P990004/S051) | Ferrosan Meidcal Devices A/S | 2021-12-21 |
| ETI-CORE-IGMK PLUS assay (P990044/S029) | DiaSorin, Inc. | 2021-12-21 |
| Dimension® TPSA Flex® reagent cartridge (P000021/S044) | Siemens Healthcare Diagnostics | 2021-12-20 |
| (WEB) Aneurysm Embolization System (P170032/S010) | MicroVention, Inc. | 2021-12-20 |
| Dimension® FPSA Flex® reagent cartridge (P020027/S039) | Siemens Healthcare Diagnostics | 2021-12-20 |
| Endurant Stent Graft System (P100021/S098) | Medtronic Vascular | 2021-12-20 |
| HeartMate 3 Left Ventricular Assist System (P160054/S041) | ABBOTT MEDICAL | 2021-12-20 |
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S110) | Biotronik, Inc. | 2021-12-20 |
| R3 Delta Ceramic Hip System (P150030/S018) | Smith & Nephew, Inc. | 2021-12-20 |
| Inspire Medical Systems, Model 2580 Patient Programmer (P130008/S069) | Inspire Medical Systems | 2021-12-18 |
| 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/S698) | Medtronic, Inc. | 2021-12-17 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S006) | DiaSorin, Inc. | 2021-12-17 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S007) | Medtronic Vascular, Inc. | 2021-12-17 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S006) | DiaSorin, Inc. | 2021-12-17 |
| 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/S799) | Medtronic Cardiac Rhythm Disease Management | 2021-12-17 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S097) | Medtronic Vascular | 2021-12-17 |
| Oxford Partial Knee System (P010014/S098) | Biomet Manufacturing Corp | 2021-12-17 |
| MiniMed 530G System (P120010/S140) | Medtronic, Inc. | 2021-12-17 |
| EMBLEM subcutaneous implantable cardioverter defibrillation (S-ICD) Programmer, EMBLEM Pulse Generator (PG) (P110042/S164) | Boston Scientific Corporation | 2021-12-17 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S053) | Medtronic, Inc. | 2021-12-17 |
| iPro 2 CGM System with Enlite Glucose Sensor (P150029/S037) | Medtronic Minimed | 2021-12-17 |
| Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant (P130014/S013) | Stryker Leibinger GmbH & Co KG | 2021-12-17 |
| LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S009) | DiaSorin, Inc. | 2021-12-17 |
| Guardian Connect system (P160007/S042) | Medtronic Minimed | 2021-12-17 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S003) | Kestra Medical Technologies, Inc. | 2021-12-17 |
| ARCHITECT AFP / Alinity i AFP (P120008/S019) | Abbott Laboratories | 2021-12-17 |
| Paradigm Real-Time Revel System (P150019/S064) | Medtronic Minimed | 2021-12-17 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S013) | DiaSorin, Inc. | 2021-12-17 |
| Barostim NEO System, Barostim NEO2 System (P180050/S001) | Cvrx, Inc. | 2021-12-17 |
| 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/S765) | Medtronic Cardiac Rhythm Disease Management | 2021-12-17 |
| MiniMed 670G System (P160017/S095) | Medtronic Minimed, Inc. | 2021-12-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor (P150003/S081) | Boston Scientific Corporation | 2021-12-17 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers (P180039/S008) | DiaSorin, Inc. | 2021-12-17 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S006) | DiaSorin, Inc. | 2021-12-17 |
| Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) (P050050/S020) | Djo Global | 2021-12-17 |
| MiniMed 630G System with SmartGuard (P150001/S093) | Medtronic Minimed | 2021-12-17 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S167) | Medtronic, Inc. | 2021-12-17 |