| Z-2167-2026 | Class II | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS | April 8, 2026 |
| Z-2168-2026 | Class II | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS | April 8, 2026 |
| Z-1949-2026 | Class II | Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Mo | March 23, 2026 |
| Z-1586-2026 | Class II | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product | February 18, 2026 |
| Z-1314-2026 | Class II | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | December 15, 2025 |
| Z-1093-2026 | Class II | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | December 12, 2025 |
| Z-1170-2025 | Class II | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Serter | January 15, 2025 |
| Z-1095-2025 | Class II | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Coll | January 8, 2025 |
| Z-0907-2025 | Class II | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. | December 13, 2024 |
| Z-0694-2025 | Class II | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | November 8, 2024 |
| Z-0328-2025 | Class I | BioZorb Marker. Radiographic soft tissue marker. | October 10, 2024 |
| Z-3248-2024 | Class II | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and | August 19, 2024 |
| Z-2373-2024 | Class II | Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizo | June 13, 2024 |
| Z-1733-2024 | Class I | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft ti | March 13, 2024 |
| Z-0782-2024 | Class II | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing s | December 15, 2023 |
| Z-1371-2024 | Class II | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplificatio | September 14, 2023 |
| Z-2035-2023 | Class II | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue | May 2, 2023 |
| Z-1144-2023 | Class II | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-0 | January 16, 2023 |
| Z-0669-2025 | Class II | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument gui | October 10, 2022 |
| Z-1858-2022 | Class II | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft | August 9, 2022 |