| Reported | Recall | Class | Product | Firm |
|---|
| 2023-06-28 | Z-1712-2023 | Class I | ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1713-2023 | Class I | ICD-DR DDMB2D1 EVERA MRI XT OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1714-2023 | Class I | ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1715-2023 | Class I | ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1716-2023 | Class I | ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1717-2023 | Class I | ICD-DR DDMD3D1 PRIMO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1718-2023 | Class I | ICD-DR DDMD3D4 PRIMO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1719-2023 | Class I | ICD-DR DDME3D1 MIRRO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1720-2023 | Class I | ICD-DR DDME3D4 MIRRO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1721-2023 | Class I | ICD COBALT XT DR MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1722-2023 | Class I | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1723-2023 | Class I | ICD COBALT XT DR MRI IS1 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1724-2023 | Class I | ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1725-2023 | Class I | ICD COBALT DR MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1726-2023 | Class I | ICD COBALT DR MRI IS1 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1727-2023 | Class I | ICD CROME DR MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1728-2023 | Class I | ICD CROME DR MRI IS1 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1729-2023 | Class I | CRT-D DTBA1D1 VIVA XT IS1/DF1 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1730-2023 | Class I | CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1731-2023 | Class I | CRT-D DTBA1D4 VIVA XT IS1/DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1732-2023 | Class I | CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1733-2023 | Class I | CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1734-2023 | Class I | CRTD VIVA QUAD XT CUST PARY GOLD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1735-2023 | Class I | CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1736-2023 | Class I | CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1737-2023 | Class I | CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1738-2023 | Class I | CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1739-2023 | Class I | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1740-2023 | Class I | CRT-D VIVA QUAD XT GOLD CTD | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1741-2023 | Class I | CRT-D DTBB1D1 VIVA S IS1/DF1 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1742-2023 | Class I | CRT-D DTBB1D4 VIVA S IS1/DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1743-2023 | Class I | CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1744-2023 | Class I | CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1745-2023 | Class I | CRT-D DTBB2D1 VIVA S IS1/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1746-2023 | Class I | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1747-2023 | Class I | CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1748-2023 | Class I | CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1749-2023 | Class I | CRT-D DTBC2D1 BRAVA IS1/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1750-2023 | Class I | CRT-D DTBC2D4 BRAVA IS1/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1751-2023 | Class I | CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1752-2023 | Class I | CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1753-2023 | Class I | CRTD DTMA1D1 CLARIA MRI US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1754-2023 | Class I | CRTD DTMA1D4 CLARIA MRI US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1755-2023 | Class I | CRTD DTMA1Q1 CLARIA MRI QUAD US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1756-2023 | Class I | CRTD DTMA1QQ CLARIA MRI QUAD US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1757-2023 | Class I | CRTD DTMA2D1 CLARIA MRI OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1758-2023 | Class I | CRTD DTMA2D4 CLARIA MRI OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1759-2023 | Class I | CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1760-2023 | Class I | CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1761-2023 | Class I | CRTD DTMB1D1 AMPLIA MRI US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1762-2023 | Class I | CRTD DTMB1D4 AMPLIA MRI US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1763-2023 | Class I | CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1764-2023 | Class I | CRTD DTMB1QQ AMPLIA MRI QUAD US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1765-2023 | Class I | CRTD DTMB2D1 AMPLIA MRI OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1766-2023 | Class I | CRTD DTMB2D4 AMPLIA MRI OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1767-2023 | Class I | CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1768-2023 | Class I | CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1769-2023 | Class I | CRTD DTMC1D1 COMPIA MRI US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1770-2023 | Class I | CRTD DTMC1QQ COMPIA MRI QUAD US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1771-2023 | Class I | CRTD DTMC2D1 COMPIA MRI OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1772-2023 | Class I | CRTD DTMC2D4 COMPIA MRI OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1773-2023 | Class I | CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1774-2023 | Class I | CRTD COBALT XT HF MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1775-2023 | Class I | CRTD DTPA2D1G COBALT XT HF QUAD OUS | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1776-2023 | Class I | CRTD DTPA2D1PX COBALT XT HF QUAD OUS | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1777-2023 | Class I | CRTD COBALT XT HF MRI IS1 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1778-2023 | Class I | CRTD COBALT XT HF QUAD MRI IS4 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1779-2023 | Class I | CRTD COBALT XT HF QUAD MRI IS4 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1780-2023 | Class I | ICD COBALT XT HF QUAD OUS | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1781-2023 | Class I | CRTD COBALT HF MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1782-2023 | Class I | CRTD COBALT HF MRI IS1 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1783-2023 | Class I | CRTD COBALT HF QUAD MRI IS4 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1784-2023 | Class I | CRTD COBALT HF QUAD MRI IS4 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1785-2023 | Class I | CRTD CROME HF MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1786-2023 | Class I | CRTD CROME HF MRI IS1 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1787-2023 | Class I | CRTD CROME HF QUAD MRI IS4 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1788-2023 | Class I | CRTD CROME HF QUAD MRI IS4 DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1789-2023 | Class I | ICD-VR DVAB1D1 VISIA AF US IS1/DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1790-2023 | Class I | ICD-VR DVAB1D4 VISIA AF US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1791-2023 | Class I | ICD-VR VISIA AF XT OUS IS1/DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1792-2023 | Class I | ICD-VR VISIA AF XT OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1793-2023 | Class I | ICD-VR VISIA AF S US/OUS IS1/DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1794-2023 | Class I | ICD-VR VISIA AF S US/OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1795-2023 | Class I | ICD-VR DVBB1D1 EVERA XT IS1/DF1 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1796-2023 | Class I | ICD-VR DVBB1D4 EVERA XT DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1797-2023 | Class I | ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1798-2023 | Class I | ICD-VR DVBB2D4 EVERA XT DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1799-2023 | Class I | ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1800-2023 | Class I | ICD-VR DVBC3D4 EVERA S DF4 GLOB | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1801-2023 | Class I | ICD-VR DVEX2E4 EV ICD OUS EV4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1802-2023 | Class I | ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1803-2023 | Class I | ICD-VR DVFB1D1 VISIA AF MRI US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1804-2023 | Class I | ICD-VR DVFB1D4 VISIA MRI AF US DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1805-2023 | Class I | ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1806-2023 | Class I | ICD-VR VISIA MRI AF XT OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1807-2023 | Class I | ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1808-2023 | Class I | ICD-VR VISIA MRI AF S US/OUS DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1809-2023 | Class I | ICD-VR DVMB1D4 EVERA MRI XT DF4 US | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1810-2023 | Class I | ICD-VR DVMB2D1 EVERA MRI XT OUS DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1811-2023 | Class I | ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1812-2023 | Class I | ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1813-2023 | Class I | ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1814-2023 | Class I | ICD-VR DVMD3D1 PRIMO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1815-2023 | Class I | ICD-VR DVMD3D4 PRIMO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1816-2023 | Class I | ICD-VR DVME3D1 MIRRO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1817-2023 | Class I | ICD-VR DVME3D4 MIRRO MRI | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1818-2023 | Class I | ICD COBALT XT VR MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1819-2023 | Class I | ICD COBALT XT VR MRI DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1820-2023 | Class I | ICD COBALT VR MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1821-2023 | Class I | ICD COBALT VR MRI DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1822-2023 | Class I | ICD CROME VR MRI IS1 DF1 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1823-2023 | Class I | ICD CROME VR MRI DF4 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| 2023-06-28 | Z-1826-2023 | Class I | ARROW Endurance Extended Dwell Peripheral Catheter System | ARROW INTERNATIONAL Inc. |
| 2023-06-28 | Z-1975-2023 | Class II | Serrated Blade Applicator Kit | Helena Laboratories, Corp. |
| 2023-06-28 | Z-1976-2023 | Class II | NextSeq 550Dx Instrument | Illumina, Inc. |
| 2023-06-28 | Z-1977-2023 | Class II | MiSeq Dx Instrument | Illumina, Inc. |
| 2023-06-28 | Z-1978-2023 | Class II | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7 | Wilson-Cook Medical Inc. |
| 2023-06-28 | Z-1979-2023 | Class II | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10 | Wilson-Cook Medical Inc. |
| 2023-06-28 | Z-1980-2023 | Class II | V-Sign Sensor 2 | SenTec AG |
| 2023-06-28 | Z-1981-2023 | Class II | KARL STORZ Radel Sterilization Trays | Karl Storz Endoscopy |
| 2023-06-28 | Z-1982-2023 | Class II | MEDLINE THERAHONEY GEL | MEDLINE INDUSTRIES, LP - Northfield |
| 2023-06-28 | Z-1983-2023 | Class II | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor | Masimo Corporation |
| 2023-06-28 | Z-1984-2023 | Class II | Masimo LNOP TC-I SpO2 | Masimo Corporation |
| 2023-06-28 | Z-1985-2023 | Class II | Masimo LNCS TC-I SpO2 | Masimo Corporation |
| 2023-06-28 | Z-1986-2023 | Class II | Masimo LNCS TC-I SpO2 | Masimo Corporation |
| 2023-06-28 | Z-1987-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended… | Olympus Corporation of the Americas |
| 2023-06-28 | Z-1988-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for… | Olympus Corporation of the Americas |
| 2023-06-28 | Z-1989-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended… | Olympus Corporation of the Americas |
| 2023-06-28 | Z-1990-2023 | Class II | Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for… | Olympus Corporation of the Americas |
| 2023-06-28 | Z-1991-2023 | Class II | Metal Tray | Karl Storz Endoscopy |
| 2023-06-28 | Z-1992-2023 | Class II | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale… | Draeger Medical Systems, Inc. |
| 2023-06-28 | Z-1993-2023 | Class II | HeartWare Ventricular Assist Device System | Heartware, Inc. |
| 2023-06-21 | Z-1667-2023 | Class I | NOxBOXi Nitric Oxide Delivery System | NOXBOX LTD |
| 2023-06-21 | Z-1693-2023 | Class II | p-Chip Wand Reader | p-Chip Corporation |
| 2023-06-21 | Z-1702-2023 | Class II | Eye and Ear Dropper | Apothecary Products, LLC |
| 2023-06-21 | Z-1703-2023 | Class II | Medicine Dropper | Apothecary Products, LLC |
| 2023-06-21 | Z-1824-2023 | Class II | 'n'-Hole Post which is a component of the Revolution External… | New Standard Device Inc |
| 2023-06-21 | Z-1825-2023 | Class II | Philips Tempus LS-Manual Defibrillator | Remote Diagnostic Technologies Ltd. |
| 2023-06-21 | Z-1906-2023 | Class II | Icelock 125 Ratchet | Ossur H / F |
| 2023-06-21 | Z-1907-2023 | Class III | Cardiosave Hybrid Intra-Aortic Balloon Pumps | Datascope Corp. |
| 2023-06-21 | Z-1908-2023 | Class II | Aspira Peritoneal Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1909-2023 | Class II | Aspira Peritoneal Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1910-2023 | Class II | Aspira Peritoneal Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1911-2023 | Class II | Aspira Peritoneal Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1912-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1913-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1914-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1915-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1916-2023 | Class II | Aspira Valve Repair Kit | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1917-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1918-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1919-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1920-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15 | Merit Medical Systems, Inc. |
| 2023-06-21 | Z-1921-2023 | Class II | Exeter V40 Trial Head | Howmedica Osteonics Corp. |
| 2023-06-21 | Z-1966-2023 | Class II | bellavista 1000 Ventilator | Vyaire Medical |
| 2023-06-21 | Z-1967-2023 | Class II | bellavista 1000e Ventilator | Vyaire Medical |
| 2023-06-21 | Z-1968-2023 | Class II | Tearaway Introducer Kit | Galt Medical Corporation |
| 2023-06-21 | Z-1969-2023 | Class II | Tearaway Introducer Set | Galt Medical Corporation |
| 2023-06-21 | Z-1970-2023 | Class II | SteriPack Sterile Polyester Spun Swabs | LumiraDx |
| 2023-06-21 | Z-1972-2023 | Class II | Driver Instrument | Boston Scientific Neuromodulation Corporation |
| 2023-06-21 | Z-1973-2023 | Class III | Total Knee Pack | American Contract Systems, Inc. |
| 2023-06-14 | Z-1630-2023 | Class I | StealthStation Cranial Software | Medtronic Navigation, Inc. |
| 2023-06-14 | Z-1633-2023 | Class I | Walnut Wearable Smart Thermometer | BearCare, Inc. |
| 2023-06-14 | Z-1649-2023 | Class I | Trilogy Evo | Philips Respironics, Inc. |
| 2023-06-14 | Z-1650-2023 | Class I | Trilogy Evo O2 and LifeVent EVO2 | Philips Respironics, Inc. |
| 2023-06-14 | Z-1651-2023 | Class I | Trilogy Evo O2 EV300 | Philips Respironics, Inc. |
| 2023-06-14 | Z-1652-2023 | Class I | Trilogy Evo Universal Ventilator | Philips Respironics, Inc. |
| 2023-06-14 | Z-1666-2023 | Class I | StealthStation Cranial Software | Medtronic Navigation, Inc. |
| 2023-06-14 | Z-1675-2023 | Class II | Elekta Unity Image-Guided Radiation Therapy System containing an MR… | Elekta, Inc. |
| 2023-06-14 | Z-1676-2023 | Class II | The 4Kscore Test is an in vitro serum or plasma test that combines… | BioReference Health, LLC |
| 2023-06-14 | Z-1677-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft… | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| 2023-06-14 | Z-1678-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft… | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| 2023-06-14 | Z-1679-2023 | Class II | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue… | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| 2023-06-14 | Z-1680-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue… | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| 2023-06-14 | Z-1681-2023 | Class II | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue… | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| 2023-06-14 | Z-1682-2023 | Class II | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B | Becton Dickinson & Co. |
| 2023-06-14 | Z-1683-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid… | Qiagen Sciences LLC |
| 2023-06-14 | Z-1684-2023 | Class II | AVNS ambIT System | Avanos Medical, Inc. |
| 2023-06-14 | Z-1685-2023 | Class II | AVNS ambIT System | Avanos Medical, Inc. |
| 2023-06-14 | Z-1686-2023 | Class II | SMMT ambIT Kit Basic Filter Luer Cass | Avanos Medical, Inc. |
| 2023-06-14 | Z-1687-2023 | Class II | SMMT ambIT Reusable Program | Avanos Medical, Inc. |
| 2023-06-14 | Z-1688-2023 | Class II | ambIT Cassette Filter Male Luer | Avanos Medical, Inc. |
| 2023-06-14 | Z-1689-2023 | Class II | The TREO ABDOMINAL STENT-GRAFT SYSTEM | Bolton Medical Inc. |
| 2023-06-14 | Z-1690-2023 | Class II | Presource Kit | Cardinal Health 200, LLC |
| 2023-06-14 | Z-1691-2023 | Class II | Sterile custom surgical procedure packs: | DeRoyal Industries Inc |
| 2023-06-14 | Z-1692-2023 | Class II | Sterile custom surgical procedure packs | DeRoyal Industries Inc |
| 2023-06-14 | Z-1694-2023 | Class III | RR Mechatronics Starrsed Control Level N ESR Control 4 | Mechatronics USA |
| 2023-06-14 | Z-1695-2023 | Class III | RR Mechatronics Control Level A ESR Control4 | Mechatronics USA |
| 2023-06-14 | Z-1696-2023 | Class III | Alinity i Anti-TPO Reagent Kit | Abbott Ireland Limited |
| 2023-06-14 | Z-1697-2023 | Class II | BencoDental iris 5% NaF varnish | Young Dental Manufacturing I, LLC |
| 2023-06-14 | Z-1698-2023 | Class II | Magic3 Go Intermittent Urinary Catheters | C.R. Bard Inc |
| 2023-06-14 | Z-1699-2023 | Class II | Magic3 Go Intermittent Urinary Catheters | C.R. Bard Inc |
| 2023-06-14 | Z-1700-2023 | Class II | Magic3 Go Intermittent Urinary Catheters | C.R. Bard Inc |
| 2023-06-14 | Z-1701-2023 | Class II | HydroSil Go Intermittent Urinary Catheters | C.R. Bard Inc |
| 2023-06-07 | Z-1627-2023 | Class II | CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and… | Trophy SAS |
| 2023-06-07 | Z-1634-2023 | Class II | HMOD 70000-USA/QUADROX-iD Adult | Maquet Medical Systems USA |
| 2023-06-07 | Z-1635-2023 | Class II | BEQ-HMOD70000-USA/QUADROX-iD | Maquet Medical Systems USA |
| 2023-06-07 | Z-1636-2023 | Class II | BEQ-HMO 50000-USA/ QUADROX-i Small | Maquet Medical Systems USA |
| 2023-06-07 | Z-1637-2023 | Class II | QUADROX-i Small Adult | Maquet Medical Systems USA |
| 2023-06-07 | Z-1638-2023 | Class II | QUADROX-i Adult | Maquet Medical Systems USA |