| Reported | Recall | Class | Product | Firm |
|---|
| 2018-06-13 | Z-2118-2018 | Class II | Rival Reduce Kit Plates | Orthofix, Inc |
| 2018-06-13 | Z-2119-2018 | Class II | Non-Locking Screw | Orthofix, Inc |
| 2018-06-13 | Z-2120-2018 | Class II | Locking Screw | Orthofix, Inc |
| 2018-06-13 | Z-2121-2018 | Class II | Non-Locking Screw | Orthofix, Inc |
| 2018-06-13 | Z-2122-2018 | Class II | Locking Screw | Orthofix, Inc |
| 2018-06-13 | Z-2123-2018 | Class II | Non-Locking Screw | Orthofix, Inc |
| 2018-06-13 | Z-2124-2018 | Class II | Locking Screw | Orthofix, Inc |
| 2018-06-13 | Z-2125-2018 | Class II | Box Plate | Orthofix, Inc |
| 2018-06-13 | Z-2126-2018 | Class II | CC Plate | Orthofix, Inc |
| 2018-06-13 | Z-2127-2018 | Class II | Evans Plate | Orthofix, Inc |
| 2018-06-13 | Z-2128-2018 | Class II | H-Plate | Orthofix, Inc |
| 2018-06-13 | Z-2129-2018 | Class II | Lapidus Plate | Orthofix, Inc |
| 2018-06-13 | Z-2130-2018 | Class II | L-Plate | Orthofix, Inc |
| 2018-06-13 | Z-2131-2018 | Class II | MTP Plate | Orthofix, Inc |
| 2018-06-13 | Z-2132-2018 | Class II | Straight Plate | Orthofix, Inc |
| 2018-06-13 | Z-2133-2018 | Class II | TN Plate | Orthofix, Inc |
| 2018-06-13 | Z-2134-2018 | Class II | T-Plate | Orthofix, Inc |
| 2018-06-13 | Z-2135-2018 | Class II | Y-Plate | Orthofix, Inc |
| 2018-06-06 | Z-1903-2018 | Class I | Heartware Medtronic HVAD System for cardiac use | Heartware |
| 2018-06-06 | Z-1928-2018 | Class I | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Maquet Datascope Corp - Cardiac Assist Division |
| 2018-06-06 | Z-1931-2018 | Class II | MEDLINE Sterile* Needle Counter | Medline Industries Inc |
| 2018-06-06 | Z-1932-2018 | Class II | MEDLINE Sterile* Needle Counter | Medline Industries Inc |
| 2018-06-06 | Z-1933-2018 | Class II | MEDLINE Sterile* Needle Counter | Medline Industries Inc |
| 2018-06-06 | Z-1934-2018 | Class II | MEDLINE O | Medline Industries Inc |
| 2018-06-06 | Z-1935-2018 | Class II | MEDLINE O | Medline Industries Inc |
| 2018-06-06 | Z-1936-2018 | Class II | MEDLINE O | Medline Industries Inc |
| 2018-06-06 | Z-1937-2018 | Class II | VOLISTA StandOP | Maquet SAS |
| 2018-06-06 | Z-1938-2018 | Class II | Disposable Drill Kit which includes two drill bits | Ad-Tech Medical Instrument Corporation |
| 2018-06-06 | Z-1939-2018 | Class II | SOMATOM go | Siemens Medical Solutions USA, Inc |
| 2018-06-06 | Z-1940-2018 | Class II | SOMATOM Go | Siemens Medical Solutions USA, Inc |
| 2018-06-06 | Z-1941-2018 | Class II | Symmetry Olsen Monopolar Pencil: | Olsen Medical |
| 2018-06-06 | Z-1942-2018 | Class II | Symmetry Olsen bipolar cord: | Olsen Medical |
| 2018-06-06 | Z-1943-2018 | Class II | Symmetry Olsen monopolar cord: | Olsen Medical |
| 2018-06-06 | Z-1944-2018 | Class II | Symmetry Olsen bipolar forceps: | Olsen Medical |
| 2018-06-06 | Z-1945-2018 | Class II | Symmetry Olsen monopolar forceps: | Olsen Medical |
| 2018-06-06 | Z-1946-2018 | Class II | Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000… | Siemens Healthcare Diagnostics, Inc. |
| 2018-06-06 | Z-1947-2018 | Class II | Respire Pink Series EF+ Oral Sleep Apnea Device | Respire Medical |
| 2018-06-06 | Z-1948-2018 | Class II | Respire Pink+ Hard/Soft Oral Sleep Apnea Device | Respire Medical |
| 2018-06-06 | Z-1949-2018 | Class II | Respire Pink+ Hard Oral Sleep Apnea Device | Respire Medical |
| 2018-06-06 | Z-1950-2018 | Class II | Respire Pink H/S Oral Sleep Apnea Device | Respire Medical |
| 2018-06-06 | Z-1951-2018 | Class II | Respire Pink H/S Oral Sleep Apnea Device | Respire Medical |
| 2018-06-06 | Z-1952-2018 | Class II | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators | Gyrus Acmi, Incorporated |
| 2018-06-06 | Z-1953-2018 | Class II | Sternal Valve Retractors With Atrial and Aortic Rakes | Genesee BioMedical, Inc. |
| 2018-06-06 | Z-1954-2018 | Class II | Carina Ventilator | Draeger Medical, Inc. |
| 2018-06-06 | Z-1955-2018 | Class II | Dynarex CGA870 All Brass Oxygen Regulator | Dynarex Corporation |
| 2018-06-06 | Z-1956-2018 | Class II | MagNA Pure 24 System | Roche Molecular Systems, Inc. |
| 2018-06-06 | Z-1957-2018 | Class II | Catheter Hemostasis Valve For use with | Arrow International Inc |
| 2018-06-06 | Z-1958-2018 | Class II | Continuous Nerve Block Needle | Arrow International Inc |
| 2018-06-06 | Z-1959-2018 | Class II | Echogenic Introducer Needle | Arrow International Inc |
| 2018-06-06 | Z-1960-2018 | Class II | Spring Wire Guide Introducer Needle | Arrow International Inc |
| 2018-06-06 | Z-1961-2018 | Class II | Epidural Needle | Arrow International Inc |
| 2018-06-06 | Z-1962-2018 | Class II | SnapLock" Catheter/Syringe Adapter | Arrow International Inc |
| 2018-06-06 | Z-1963-2018 | Class II | Maximal Barrier Drape | Arrow International Inc |
| 2018-06-06 | Z-1964-2018 | Class II | Maximal Barrier Drape | Arrow International Inc |
| 2018-06-06 | Z-1965-2018 | Class II | Maximal Barrier Drape | Arrow International Inc |
| 2018-06-06 | Z-1966-2018 | Class II | Maximal Barrier Drape | Arrow International Inc |
| 2018-06-06 | Z-1967-2018 | Class II | Maximal Barrier Drape | Arrow International Inc |
| 2018-06-06 | Z-1968-2018 | Class II | Radial Arterial Access Kit | Arrow International Inc |
| 2018-06-06 | Z-1969-2018 | Class II | Arterial Line Kit with Sharps Safety Features and Maximal Barrier… | Arrow International Inc |
| 2018-06-06 | Z-1970-2018 | Class II | Radial Artery Catheterization Kit | Arrow International Inc |
| 2018-06-06 | Z-1971-2018 | Class II | Arterial Catheterization Kit | Arrow International Inc |
| 2018-06-06 | Z-1972-2018 | Class II | Radial Artery Catheterization Kit with Sharps Safety Features | Arrow International Inc |
| 2018-06-06 | Z-1973-2018 | Class II | Radial Artery Catheterization Kit with Sharps Safety Features | Arrow International Inc |
| 2018-06-06 | Z-1974-2018 | Class II | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-1975-2018 | Class II | Arrow-Flex | Arrow International Inc |
| 2018-06-06 | Z-1976-2018 | Class II | Percutaneous Sheath Introducer Kit with Integral Hemostasis… | Arrow International Inc |
| 2018-06-06 | Z-1977-2018 | Class II | Percutaneous Sheath Introducer Kit with Integral Hemostasis… | Arrow International Inc |
| 2018-06-06 | Z-1978-2018 | Class II | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-1979-2018 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit… | Arrow International Inc |
| 2018-06-06 | Z-1980-2018 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit | Arrow International Inc |
| 2018-06-06 | Z-1981-2018 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit | Arrow International Inc |
| 2018-06-06 | Z-1982-2018 | Class II | ARROWg+ard Blue | Arrow International Inc |
| 2018-06-06 | Z-1983-2018 | Class II | MAC | Arrow International Inc |
| 2018-06-06 | Z-1984-2018 | Class II | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-1985-2018 | Class II | ARROWg+ard Blue | Arrow International Inc |
| 2018-06-06 | Z-1986-2018 | Class II | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue | Arrow International Inc |
| 2018-06-06 | Z-1987-2018 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-1988-2018 | Class II | Pressure Injectable ARROWg+ard Blue PLUS | Arrow International Inc |
| 2018-06-06 | Z-1989-2018 | Class II | ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit | Arrow International Inc |
| 2018-06-06 | Z-1990-2018 | Class II | Pressure Injectable Two-Lumen Central Venous Catheterization Kit with… | Arrow International Inc |
| 2018-06-06 | Z-1991-2018 | Class II | Pressure Injectable Quad-Lumen Central Venous Catheterization Kit… | Arrow International Inc |
| 2018-06-06 | Z-1992-2018 | Class II | ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit | Arrow International Inc |
| 2018-06-06 | Z-1993-2018 | Class II | Pressure Injectable ARROWg+ard Blue PLUS | Arrow International Inc |
| 2018-06-06 | Z-1994-2018 | Class II | ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit | Arrow International Inc |
| 2018-06-06 | Z-1995-2018 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit… | Arrow International Inc |
| 2018-06-06 | Z-1996-2018 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit… | Arrow International Inc |
| 2018-06-06 | Z-1997-2018 | Class II | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit… | Arrow International Inc |
| 2018-06-06 | Z-1998-2018 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-1999-2018 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-2000-2018 | Class II | ARROWg+ard Blue PLUS | Arrow International Inc |
| 2018-06-06 | Z-2001-2018 | Class II | Double-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-2002-2018 | Class II | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-2003-2018 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-2004-2018 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip | Arrow International Inc |
| 2018-06-06 | Z-2005-2018 | Class II | ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter | Arrow International Inc |
| 2018-06-06 | Z-2006-2018 | Class II | 4Fr | Arrow International Inc |
| 2018-06-06 | Z-2007-2018 | Class II | 5Fr | Arrow International Inc |
| 2018-06-06 | Z-2008-2018 | Class II | 7Fr | Arrow International Inc |
| 2018-06-06 | Z-2009-2018 | Class II | 8Fr | Arrow International Inc |
| 2018-06-06 | Z-2010-2018 | Class II | Clear Fenestrated Drape with Adhesive | Arrow International Inc |
| 2018-06-06 | Z-2011-2018 | Class II | Spring-Wire Guide Introducer Catheter Assembly | Arrow International Inc |
| 2018-06-06 | Z-2012-2018 | Class II | TheraCath | Arrow International Inc |
| 2018-06-06 | Z-2013-2018 | Class II | 0 | Arrow International Inc |
| 2018-06-06 | Z-2014-2018 | Class II | Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography | Arrow International Inc |
| 2018-06-06 | Z-2015-2018 | Class II | ARROW JACC with Chlorag+ard Technology | Arrow International Inc |
| 2018-06-06 | Z-2016-2018 | Class II | 10 cc Luer-Slip Loss of Resistance Syringe | Arrow International Inc |
| 2018-06-06 | Z-2017-2018 | Class II | Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and… | Arrow International Inc |
| 2018-06-06 | Z-2018-2018 | Class II | ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter | Arrow International Inc |
| 2018-06-06 | Z-2019-2018 | Class II | Arterial Catheterization Kit | Arrow International Inc |
| 2018-06-06 | Z-2020-2018 | Class II | PICC Catheter Trimmer | Arrow International Inc |
| 2018-06-06 | Z-2021-2018 | Class II | Peel Away Sheath over Dilator | Arrow International Inc |
| 2018-06-06 | Z-2022-2018 | Class II | Echogenic Needle | Arrow International Inc |
| 2018-06-06 | Z-2023-2018 | Class II | ARROW PICC Set | Arrow International Inc |
| 2018-06-06 | Z-2024-2018 | Class II | ARROW PICC Set | Arrow International Inc |
| 2018-06-06 | Z-2025-2018 | Class II | Arrow PICC with Chlorag+ard Technology | Arrow International Inc |
| 2018-06-06 | Z-2026-2018 | Class II | VPS Rhythm ECG Accessory Pack with Johans Adapter | Arrow International Inc |
| 2018-06-06 | Z-2027-2018 | Class II | VPS Rhythm ECG Accessory Pack | Arrow International Inc |
| 2018-06-06 | Z-2028-2018 | Class II | VPS TipTracker Stylet Accessory | Arrow International Inc |
| 2018-06-06 | Z-2029-2018 | Class II | Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use… | Arrow International Inc |
| 2018-06-06 | Z-2030-2018 | Class II | Extension Line Slide Clamps | Arrow International Inc |
| 2018-06-06 | Z-2031-2018 | Class II | ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port… | Arrow International Inc |
| 2018-06-06 | Z-2032-2018 | Class II | 9 Fr | Arrow International Inc |
| 2018-06-06 | Z-2033-2018 | Class II | P | Joerns Healthcare |
| 2018-06-06 | Z-2034-2018 | Class II | ProCair Mattress: | Joerns Healthcare |
| 2018-06-06 | Z-2035-2018 | Class II | HeartStart MRx Monitor/Defibrillator | Philips Electronics North America Corporation |
| 2018-06-06 | Z-2036-2018 | Class II | AmerisourceBergen PF Latex SG | WRP Asia Pacific Sdn Bhd |
| 2018-06-06 | Z-2037-2018 | Class II | LINX Reflux Management System | Torax Medical, Inc. |
| 2018-06-06 | Z-2038-2018 | Class II | LINX Reflux Management System | Torax Medical, Inc. |
| 2018-06-06 | Z-2039-2018 | Class II | LINX Reflux Management System | Torax Medical, Inc. |
| 2018-06-06 | Z-2040-2018 | Class II | LINX Reflux Management System | Torax Medical, Inc. |
| 2018-06-06 | Z-2041-2018 | Class II | LINX Reflux Management System | Torax Medical, Inc. |
| 2018-06-06 | Z-2042-2018 | Class II | nordicTumorEx 1 | NordicNeuroLab AS |
| 2018-06-06 | Z-2043-2018 | Class II | Medical Action Industries Inc | Medical Action Industries Inc |
| 2018-06-06 | Z-2044-2018 | Class II | nordicICE 2 | NordicNeuroLab AS |
| 2018-06-06 | Z-2045-2018 | Class II | nordicBrainEX Product Usage: nordicBrainEx is an image processing… | NordicNeuroLab AS |
| 2018-06-06 | Z-2048-2018 | Class II | HARMONIC ACE Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery Inc |
| 2018-06-06 | Z-2049-2018 | Class II | HARMONIC ACE Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery Inc |
| 2018-05-30 | Z-1894-2018 | Class II | iChem VELOCITY Automated Urine Chemistry System | Beckman Coulter Inc. |
| 2018-05-30 | Z-1895-2018 | Class II | First Step Endoscopic Cleaning Pad | Madison Polymeric Engineering |
| 2018-05-30 | Z-1896-2018 | Class II | First Step Endoscopic Cleaning Pad | Madison Polymeric Engineering |
| 2018-05-30 | Z-1897-2018 | Class II | First Step Endoscopic Cleaning Pad with 4" Button Brush | Madison Polymeric Engineering |
| 2018-05-30 | Z-1898-2018 | Class II | First Step Endoscopic Cleaning Pad | Madison Polymeric Engineering |
| 2018-05-30 | Z-1899-2018 | Class II | Travel Kit | Madison Polymeric Engineering |
| 2018-05-30 | Z-1900-2018 | Class II | Draco Enzymatic Deep-Cleaning Pad | Madison Polymeric Engineering |
| 2018-05-30 | Z-1901-2018 | Class II | Sorin Stockert Heater-Cooler System 3T | LivaNova USA |
| 2018-05-30 | Z-1902-2018 | Class II | smith&nephew 5o | Smith & Nephew, Inc. |
| 2018-05-30 | Z-1904-2018 | Class II | smith&nephew LEGION | Smith & Nephew, Inc. |
| 2018-05-30 | Z-1905-2018 | Class II | smith&nephew LEGION | Smith & Nephew, Inc. |
| 2018-05-30 | Z-1906-2018 | Class II | smith&nephew LEGION | Smith & Nephew, Inc. |
| 2018-05-30 | Z-1907-2018 | Class II | smith&nephew LEGION | Smith & Nephew, Inc. |
| 2018-05-30 | Z-1908-2018 | Class II | Baxter EXACTAMIX Inlet | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1909-2018 | Class II | Baxter EXACTAMIX Inlet | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1910-2018 | Class II | Baxter EXACTAMIX Inlet | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1911-2018 | Class II | Baxter EXACTAMIX Inlet | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1912-2018 | Class II | AMENDIA Omega Lumbar Interbody Fusion Device | Spinal Elements |
| 2018-05-30 | Z-1913-2018 | Class II | Philips HeartStart FRx AED | Philips Electronics North America Corp. |
| 2018-05-30 | Z-1914-2018 | Class II | Philips HeartStart | Philips Electronics North America Corp. |
| 2018-05-30 | Z-1916-2018 | Class II | Synthes Torque Limiting Handle | Synthes (USA) Products LLC |
| 2018-05-30 | Z-1917-2018 | Class II | ImplantDirect simply InterActive Implant | Implant Direct Sybron Manufacturing, LLC |
| 2018-05-30 | Z-1918-2018 | Class II | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir | LivaNova USA |
| 2018-05-30 | Z-1919-2018 | Class II | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir | LivaNova USA |
| 2018-05-30 | Z-1920-2018 | Class II | ImplantDirect Legacy 4 Implant | Implant Direct Sybron Manufacturing, LLC |
| 2018-05-30 | Z-1921-2018 | Class II | smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM | Smith & Nephew, Inc. |
| 2018-05-30 | Z-1922-2018 | Class II | Prismaflex System | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1923-2018 | Class II | Prismaflex 5 | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1924-2018 | Class II | Prismaflex 7 | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1925-2018 | Class II | Prismaflex 7 | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1926-2018 | Class II | Prismaflex 7 | Baxter Healthcare Corporation |
| 2018-05-30 | Z-1927-2018 | Class II | ALM XTEN Surgical Light intended to provide visible illumination for… | GETINGE US SALES LLC |
| 2018-05-30 | Z-1929-2018 | Class II | Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC |
| 2018-05-30 | Z-1930-2018 | Class II | Biograph Horizon | Siemens Medical Solutions USA, Inc. |
| 2018-05-23 | Z-1701-2018 | Class I | MindFrame Capture LP Revascularization Devices: Product Numbers: | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| 2018-05-23 | Z-1745-2018 | Class II | SOMATOM Definition AS | Siemens Medical Solutions USA, Inc |
| 2018-05-23 | Z-1746-2018 | Class II | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc |
| 2018-05-23 | Z-1747-2018 | Class II | SOMATOM Definition Flash | Siemens Medical Solutions USA, Inc |
| 2018-05-23 | Z-1748-2018 | Class II | SOMATOM Force | Siemens Medical Solutions USA, Inc |
| 2018-05-23 | Z-1774-2018 | Class I | Thoratec HeartMate 3 LVAS Implant Kit | Abbott |
| 2018-05-23 | Z-1802-2018 | Class II | BARD PERIPHERAL VASCULAR SEEKER | Bard Peripheral Vascular Inc |
| 2018-05-23 | Z-1803-2018 | Class II | BARD PERIPHERAL VASCULAR SEEKER | Bard Peripheral Vascular Inc |
| 2018-05-23 | Z-1804-2018 | Class II | BECKMAN COULTER MicroScan MICroSTREP Plus Panel | Beckman Coulter Inc. |
| 2018-05-23 | Z-1805-2018 | Class II | Persona Stemmed Tibial Provisional Size H Left | Zimmer Biomet, Inc. |
| 2018-05-23 | Z-1806-2018 | Class II | Persona Stemmed Tibial Provisional Size H Right | Zimmer Biomet, Inc. |
| 2018-05-23 | Z-1807-2018 | Class II | Persona Cemented Tibial SZ PLT Size H Left | Zimmer Biomet, Inc. |
| 2018-05-23 | Z-1808-2018 | Class II | Persona Cemented Tibial SZ PLT Size H Right | Zimmer Biomet, Inc. |
| 2018-05-23 | Z-1809-2018 | Class II | Tosoh ST AIA-PACK HbA1c | Tosoh Bioscience Inc |
| 2018-05-23 | Z-1810-2018 | Class II | Tosoh ST AIA-PACK HbA1c Calibrator | Tosoh Bioscience Inc |
| 2018-05-23 | Z-1811-2018 | Class II | Tosoh ST AIA-PACK HbA1c Control | Tosoh Bioscience Inc |
| 2018-05-23 | Z-1812-2018 | Class II | Tosoh ST AIA-PACK HbA1c Pretreatment Solution | Tosoh Bioscience Inc |
| 2018-05-23 | Z-1813-2018 | Class II | Infinity Acute Care System | Draegar Medical Systems, Inc. |
| 2018-05-23 | Z-1814-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2 | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1815-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1816-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1817-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1818-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3 | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1819-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2 | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1820-2018 | Class II | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1821-2018 | Class II | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with… | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1822-2018 | Class II | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with… | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1823-2018 | Class II | Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with… | COVIDIEN MEDTRONIC |
| 2018-05-23 | Z-1824-2018 | Class II | Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo… | COVIDIEN MEDTRONIC |