| Reported | Recall | Class | Product | Firm |
|---|
| 2023-07-12 | Z-2078-2023 | Class II | PriMatrix Fenestrated | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2079-2023 | Class II | PriMatrix Meshed | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2080-2023 | Class II | PriMatrix Ag | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2081-2023 | Class II | PriMatrix Ag Fenestrated | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2082-2023 | Class II | PriMatrix Ag Meshed | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2083-2023 | Class II | Revize | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2084-2023 | Class II | Revize-X | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2085-2023 | Class II | TissueMend | TEI Biosciences, Inc. |
| 2023-07-12 | Z-2086-2023 | Class II | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART | DeRoyal Industries Inc |
| 2023-07-12 | Z-2087-2023 | Class II | Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY… | DeRoyal Industries Inc |
| 2023-07-12 | Z-2088-2023 | Class II | Custom medical procedure packs labeled as: a) STANDARD OB PACK… | DeRoyal Industries Inc |
| 2023-07-12 | Z-2089-2023 | Class II | Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY | DeRoyal Industries Inc |
| 2023-07-12 | Z-2090-2023 | Class II | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE… | DeRoyal Industries Inc |
| 2023-07-12 | Z-2091-2023 | Class II | Aptio Automation Storage and Retrieval Module | Siemens Healthcare Diagnostics, Inc. |
| 2023-07-12 | Z-2092-2023 | Class II | NexGen Precoat Stemmed Tibial Plate Size 5 | Zimmer, Inc. |
| 2023-07-12 | Z-2093-2023 | Class III | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection… | NeuMoDx Molecular Inc |
| 2023-07-12 | Z-2094-2023 | Class II | BD Pyxis CII Safe | CareFusion 303, Inc. |
| 2023-07-12 | Z-2095-2023 | Class II | Pilling O'REILLY ESOPHAGEAL RETRACTOR | TELEFLEX LLC |
| 2023-07-12 | Z-2096-2023 | Class II | Pilling LOWSLEY PROSTATIC TRACTOR CVD | TELEFLEX LLC |
| 2023-07-12 | Z-2097-2023 | Class II | Pilling LOWSLEY PROSTATIC TRACTOR STR | TELEFLEX LLC |
| 2023-07-12 | Z-2098-2023 | Class II | KLS Martin Battery Pack | Pro-Dex Inc |
| 2023-07-12 | Z-2099-2023 | Class II | BD Synapsys Informatics Solution | Becton Dickinson & Co. |
| 2023-07-12 | Z-2100-2023 | Class II | Giraffe OmniBed Carestation CS1 | DATEX--OHMEDA, INC. |
| 2023-07-12 | Z-2101-2023 | Class II | Giraffe OmniBed | DATEX--OHMEDA, INC. |
| 2023-07-12 | Z-2102-2023 | Class II | Beside panel FRU | DATEX--OHMEDA, INC. |
| 2023-07-12 | Z-2105-2023 | Class II | Stryker Infinity Alignment Frame Distal Sub-Assembly | Wright Medical Technology, Inc. |
| 2023-07-12 | Z-2106-2023 | Class II | Trilogy Evo | Philips Respironics, Inc. |
| 2023-07-05 | Z-1827-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1828-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1829-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1830-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1831-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1832-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1833-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1834-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1835-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1836-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1837-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1838-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1839-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1840-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1841-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1842-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1843-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1844-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1845-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1846-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1847-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1848-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1849-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1850-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1851-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1852-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1853-2023 | Class I | Flexi-Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1854-2023 | Class I | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1855-2023 | Class I | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1856-2023 | Class I | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1857-2023 | Class I | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1858-2023 | Class I | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1859-2023 | Class I | Flexi-Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1860-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1861-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1862-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1863-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1864-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1865-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1866-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1867-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1868-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1869-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1870-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1871-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1872-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1873-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1874-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1875-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1876-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1877-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1878-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1879-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1880-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1881-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1882-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1883-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1884-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1885-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1886-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1887-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1888-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1889-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1890-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1891-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1892-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1893-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1894-2023 | Class I | Endotracheal Tube oral/nasal Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1895-2023 | Class I | RUSCHELIT Safety Clear Tracheal Tube | TELEFLEX LLC |
| 2023-07-05 | Z-1896-2023 | Class I | RUSCHELIT Safety Clear Tracheal Tube | TELEFLEX LLC |
| 2023-07-05 | Z-1897-2023 | Class I | RUSCHELIT Safety Clear Tracheal Tube | TELEFLEX LLC |
| 2023-07-05 | Z-1898-2023 | Class I | RUSCHELIT Safety Clear Tracheal Tube | TELEFLEX LLC |
| 2023-07-05 | Z-1899-2023 | Class I | RUSCHELIT Safety Clear Tracheal Tube | TELEFLEX LLC |
| 2023-07-05 | Z-1900-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1901-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1902-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1903-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1904-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1905-2023 | Class I | Slick Set Uncuffed Endotracheal Tube and Stylet Set | TELEFLEX LLC |
| 2023-07-05 | Z-1922-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1923-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1924-2023 | Class I | Preformed AGT Oral Endotracheal Tube uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1925-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1926-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1927-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1928-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1929-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1930-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1931-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1932-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1933-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1934-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1935-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1936-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1937-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1938-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1939-2023 | Class I | Endotracheal Tube oral/nasal uncuffed/plain | TELEFLEX LLC |
| 2023-07-05 | Z-1940-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1941-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1942-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1943-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1944-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1945-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1946-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1947-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1948-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1949-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1950-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1951-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1952-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1953-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1954-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1955-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1956-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1957-2023 | Class I | Preformed AGT Oral Endotracheal Tube Murphy Eye | TELEFLEX LLC |
| 2023-07-05 | Z-1958-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1959-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1960-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1961-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1962-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1963-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1964-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1965-2023 | Class I | Endotracheal Tube oral/nasal Magill | TELEFLEX LLC |
| 2023-07-05 | Z-1971-2023 | Class II | Integre Pro Yellow LP561 | Ellex Medical Pty Ltd. |
| 2023-07-05 | Z-1994-2023 | Class I | MEGADYNE MEGA 2000 Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-1995-2023 | Class I | MEGADYNE MEGA SOFT Reusable Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-1996-2023 | Class I | MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-1997-2023 | Class I | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-1998-2023 | Class I | MEGADYNE MEGA SOFT Universal Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-1999-2023 | Class I | MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-2000-2023 | Class I | MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-2001-2023 | Class I | MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode | Megadyne Medical Products, Inc. |
| 2023-07-05 | Z-2002-2023 | Class II | Perifix¿ / Epidural anesthesia kit | B. Braun Medical, Inc. |
| 2023-07-05 | Z-2003-2023 | Class II | Design Options¿ / Epidural anesthesia kit | B. Braun Medical, Inc. |
| 2023-07-05 | Z-2004-2023 | Class II | PushTracker E2 component utilized with the SmartDrive MX2+ Power… | Permobil |
| 2023-07-05 | Z-2005-2023 | Class II | PushTracker E3 component utilized with the SmartDrive MX2+ Power… | Permobil |
| 2023-07-05 | Z-2006-2023 | Class II | Voalte Patient Safety | Baxter Healthcare Corporation |
| 2023-07-05 | Z-2007-2023 | Class II | NaviCare Patient Safety V3 | Baxter Healthcare Corporation |
| 2023-07-05 | Z-2008-2023 | Class II | Medtronic ILLUMISITE Platform Console | Covidien, LLC |
| 2023-07-05 | Z-2009-2023 | Class II | REF 1975 | Limacorporate S.p.A |
| 2023-07-05 | Z-2010-2023 | Class II | REF 1975 | Limacorporate S.p.A |
| 2023-07-05 | Z-2019-2023 | Class II | AEQUALIS FLEX REVIVE Assembly Screw 0mm | Tornier, Inc |
| 2023-07-05 | Z-2020-2023 | Class II | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short | Tornier, Inc |
| 2023-07-05 | Z-2021-2023 | Class III | Immunoassay Premium Level 3-In vitro diagnostic use | Randox Laboratories Ltd. |
| 2023-07-05 | Z-2022-2023 | Class III | Immunoassay Premium Control Tri Level-In vitro diagnostic use | Randox Laboratories Ltd. |
| 2023-07-05 | Z-2023-2023 | Class II | Verigene Enteric Pathogens Nucleic Acid Test | Luminex Corporation |
| 2023-07-05 | Z-2024-2023 | Class II | VERIGENE Clostridium difficile Nucleic Acid Test | Luminex Corporation |
| 2023-07-05 | Z-2025-2023 | Class II | Philips Respironics V60 Ventilator-Intended to mechanically control… | DRE Medical Group Inc |
| 2023-07-05 | Z-2035-2023 | Class II | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core… | Hologic, Inc |
| 2023-07-05 | Z-2036-2023 | Class II | Vanta with AdaptiveStim Implantable Neurostimulator | Medtronic Neuromodulation |
| 2023-07-05 | Z-2037-2023 | Class II | LEGACY SMARTBASE | Implant Direct Sybron Manufacturing LLC |
| 2023-07-05 | Z-2038-2023 | Class II | Remel Haemophilus Test Medium | Remel, Inc |
| 2023-07-05 | Z-2039-2023 | Class II | Radiation therapy software | RaySearch America Inc |
| 2023-07-05 | Z-2040-2023 | Class II | EliA GliadinDP IgG Well in the Phadia 2500EE instrument | Phadia US Inc |
| 2023-07-05 | Z-2041-2023 | Class II | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative… | Phadia US Inc |
| 2023-07-05 | Z-2042-2023 | Class II | DigitalDiagnost C90 | Philips North America Llc |
| 2023-07-05 | Z-2043-2023 | Class II | Access Hybritech p2PSA reagent | Beckman Coulter, Inc. |
| 2023-07-05 | Z-2044-2023 | Class II | RelieVR REF: RVX-2002 | Appliedvr |
| 2023-07-05 | Z-2045-2023 | Class II | wDR 2 | SEDECAL SA |
| 2023-07-05 | Z-2046-2023 | Class II | LINK Endo-Model Modular Knee Prosthesis System Femoral Segment | Waldemar Link GmbH & Co. KG (Mfg Site) |
| 2023-07-05 | Z-2047-2023 | Class II | LINK Endo-Model Modular Knee Prosthesis System Femoral Segment | Waldemar Link GmbH & Co. KG (Mfg Site) |
| 2023-07-05 | Z-2048-2023 | Class II | LINK Endo-Model Modular Knee Prosthesis System Femoral Segment | Waldemar Link GmbH & Co. KG (Mfg Site) |
| 2023-07-05 | Z-2049-2023 | Class II | LINK Endo-Model Modular Knee Prosthesis System Femoral Segment | Waldemar Link GmbH & Co. KG (Mfg Site) |
| 2023-07-05 | Z-2050-2023 | Class II | Exactech Shoulder GPS Impactor Handle | Exactech, Inc. |
| 2023-07-05 | Z-2051-2023 | Class II | Exactech Ergo Impactor Handle | Exactech, Inc. |
| 2023-06-28 | Z-1704-2023 | Class I | ICD-DR DDBB1D1 EVERA XT IS1/DF1 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1705-2023 | Class I | ICD-DR DDBB1D4 EVERA XT IS1/DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1706-2023 | Class I | ICD EVERA XT DR GOLD CTD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1707-2023 | Class I | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1708-2023 | Class I | ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1709-2023 | Class I | ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1710-2023 | Class I | ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1711-2023 | Class I | ICD-DR DDMB1D1 EVERA MRI XT US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |