| Z-2070-2019 | Class I | ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) | June 20, 2019 |
| Z-2071-2019 | Class I | ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) | June 20, 2019 |
| Z-2072-2019 | Class I | ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738 | June 20, 2019 |
| Z-2073-2019 | Class I | ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) | June 20, 2019 |
| Z-2075-2019 | Class I | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615 | June 20, 2019 |
| Z-2074-2019 | Class I | ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 | June 20, 2019 |
| Z-2335-2018 | Class II | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, extern | April 16, 2018 |
| Z-2319-2018 | Class II | Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/1000 | April 16, 2018 |
| Z-2318-2018 | Class II | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/5 | April 16, 2018 |
| Z-2321-2018 | Class II | Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/10004234 | April 16, 2018 |
| Z-2324-2018 | Class II | Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, | April 16, 2018 |
| Z-2323-2018 | Class II | Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/10001376 | April 16, 2018 |
| Z-2329-2018 | Class II | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | April 16, 2018 |
| Z-2327-2018 | Class II | Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, | April 16, 2018 |
| Z-2325-2018 | Class II | Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD32 | April 16, 2018 |
| Z-2328-2018 | Class II | Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, | April 16, 2018 |
| Z-2334-2018 | Class II | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm R | April 16, 2018 |
| Z-2326-2018 | Class II | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029 | April 16, 2018 |
| Z-2320-2018 | Class II | Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/10002 | April 16, 2018 |
| Z-2322-2018 | Class II | Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, | April 16, 2018 |