Medical device recalls reported in 2021

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Reported	Recall	Class	Product	Firm
2021-07-21	Z-2076-2021	Class II	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor…	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-07-21	Z-2077-2021	Class II	BULKAMID	Axonics Modulation Technologies, Inc.
2021-07-21	Z-2078-2021	Class II	Unifine Pentips Plus	Owen Mumford USA, Inc.
2021-07-21	Z-2079-2021	Class II	Avanti¿+ Catheter Sheath Introducer	Cordis Corporation
2021-07-14	Z-1992-2021	Class II	HydraVision Digital Imaging System Product ID/Reorder Number: 705559	LIEBEL-FLARSHEIM COMPANY LLC
2021-07-14	Z-1998-2021	Class II	Essentio pacemaker	Boston Scientific Corporation
2021-07-14	Z-1999-2021	Class II	Proponent pacemaker	Boston Scientific Corporation
2021-07-14	Z-2000-2021	Class II	Accolade pacemaker	Boston Scientific Corporation
2021-07-14	Z-2001-2021	Class II	Altrua 2 pacemaker	Boston Scientific Corporation
2021-07-14	Z-2002-2021	Class II	VALITUDE CRT-P pacemaker	Boston Scientific Corporation
2021-07-14	Z-2003-2021	Class II	VISIONIST CRT-P pacemaker	Boston Scientific Corporation
2021-07-14	Z-2004-2021	Class II	Revolution CT	GE Healthcare, LLC
2021-07-14	Z-2006-2021	Class II	Verigene Respiratory Pathogens Flex Nucleic Acid Test	Luminex Corporation
2021-07-14	Z-2007-2021	Class II	Verigene Gram-Positive Blood Culture Nucleic Acid Test	Luminex Corporation
2021-07-14	Z-2008-2021	Class II	Verigene Gram Negative Blood Culture Nucleic Acid Test	Luminex Corporation
2021-07-14	Z-2009-2021	Class II	Verigene Enteric Pathogens Nucleic Acid Test	Luminex Corporation
2021-07-14	Z-2010-2021	Class II	Verigene Clostridium difficile Nucleic Acid Test Kit	Luminex Corporation
2021-07-14	Z-2011-2021	Class II	Verigene Gram Negative Blood Culture Nucleic Acid Test v2	Luminex Corporation
2021-07-14	Z-2012-2021	Class III	ACE Control Set	Sentinel CH SpA
2021-07-14	Z-2013-2021	Class II	Randox RX Imola Analyser with ISE	Randox Laboratories Ltd.
2021-07-14	Z-2014-2021	Class II	The ADVIA Chemistry XPT Chemistry System	Siemens Healthcare Diagnostics, Inc.
2021-07-14	Z-2021-2021	Class II	The system is intended to produce cross-sectional images of the body…	GE Healthcare, LLC
2021-07-14	Z-2022-2021	Class II	The system is intended to produce cross-sectional images of the body…	GE Healthcare, LLC
2021-07-14	Z-2023-2021	Class II	The system is intended to produce cross-sectional images of the body…	GE Healthcare, LLC
2021-07-14	Z-2024-2021	Class II	Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect…	Vivorte, Inc.
2021-07-14	Z-2026-2021	Class II	Atellica CH 930 Analyzer	Siemens Healthcare Diagnostics, Inc.
2021-07-14	Z-2027-2021	Class II	Atellica IM 1300 Analyzer	Siemens Healthcare Diagnostics, Inc.
2021-07-14	Z-2028-2021	Class II	Atellica IM 1600 Analyzer- multi-component system for in vitro…	Siemens Healthcare Diagnostics, Inc.
2021-07-14	Z-2029-2021	Class II	ARTIS pheno- angiography systems developed for single and biplane…	Siemens Medical Solutions USA, Inc
2021-07-14	Z-2030-2021	Class II	FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems	The Binding Site Group, Ltd.
2021-07-14	Z-2031-2021	Class II	Sterile Femoral Angiography Drape with Single Pouch	Cardinal Health 200, LLC
2021-07-14	Z-2032-2021	Class II	Nonsterile Femoral Angiography Drape with Single Pouch	Cardinal Health 200, LLC
2021-07-14	Z-2033-2021	Class II	Sterile Radial/Femoral Angiography Drape	Cardinal Health 200, LLC
2021-07-14	Z-2034-2021	Class II	Nonsterile Radial/Femoral Angiography Drape	Cardinal Health 200, LLC
2021-07-14	Z-2035-2021	Class II	Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen	Cardinal Health 200, LLC
2021-07-14	Z-2036-2021	Class II	Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia…	Cardinal Health 200, LLC
2021-07-14	Z-2037-2021	Class II	Sterile Femoral Angiography Drape	Cardinal Health 200, LLC
2021-07-14	Z-2038-2021	Class II	Nonsterile Femoral Angiography Drape	Cardinal Health 200, LLC
2021-07-14	Z-2039-2021	Class II	FilmArray Pneumonia Panel	BioFire Diagnostics, LLC
2021-07-14	Z-2040-2021	Class II	FilmArray Pneumonia Panel plus	BioFire Diagnostics, LLC
2021-07-14	Z-2041-2021	Class II	CoreValve Evolut R Delivery Catheter System	Medtronic Heart Valves Division
2021-07-14	Z-2042-2021	Class II	CoreValve Evolut PRO Delivery Catheter System	Medtronic Heart Valves Division
2021-07-14	Z-2043-2021	Class II	CoreValve Evolut PRO PLUS Delivery Catheter System	Medtronic Heart Valves Division
2021-07-07	Z-1900-2021	Class II	Revolution EVO	GE Healthcare, LLC
2021-07-07	Z-1928-2021	Class I	Lyra SARS-CoV-2 Assay	Quidel Corporation
2021-07-07	Z-1952-2021	Class I	LeadCare II Blood Lead Test Kit Catalog Number 70-6762	Magellan Diagnostics, Inc.
2021-07-07	Z-1953-2021	Class I	LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004	Magellan Diagnostics, Inc.
2021-07-07	Z-1954-2021	Class I	LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098	Magellan Diagnostics, Inc.
2021-07-07	Z-1955-2021	Class II	Synaptive Trackable Suction Set Standard and Malleable	Synaptive Medical Inc
2021-07-07	Z-1959-2021	Class II	Edwards TruWave	Edwards Lifesciences, LLC
2021-07-07	Z-1960-2021	Class II	Edwards TruWave	Edwards Lifesciences, LLC
2021-07-07	Z-1961-2021	Class II	Edwards TruWave x 2	Edwards Lifesciences, LLC
2021-07-07	Z-1962-2021	Class II	Edwards REF: VJ0990	Edwards Lifesciences, LLC
2021-07-07	Z-1963-2021	Class II	Edwards VAMP Jr	Edwards Lifesciences, LLC
2021-07-07	Z-1964-2021	Class II	Edwards TruWave	Edwards Lifesciences, LLC
2021-07-07	Z-1965-2021	Class II	Edwards TruWave 3 cc/VAMP Jr Kit	Edwards Lifesciences, LLC
2021-07-07	Z-1966-2021	Class II	Edwards TruWave	Edwards Lifesciences, LLC
2021-07-07	Z-1967-2021	Class II	Dragonfly Laryngeal Surface Electrode	Spes Medica
2021-07-07	Z-1968-2021	Class II	SNS Disposable Urethral Catheter Electrode	Spes Medica
2021-07-07	Z-1969-2021	Class II	Dragonfly Laryngeal Surface Electrode	Spes Medica
2021-07-07	Z-1970-2021	Class II	SNS Disposable Urethral Catheter Electrode	Spes Medica
2021-07-07	Z-1971-2021	Class II	Tripolar Hooked Stimulation Probes	Spes Medica
2021-07-07	Z-1975-2021	Class II	PERLA TL Lateral Connector Open	SPINEART SA
2021-07-07	Z-1976-2021	Class II	Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR…	Medtronic Vascular, Inc.
2021-07-07	Z-1977-2021	Class II	Humeral Augmented Tray	Exactech, Inc.
2021-07-07	Z-1978-2021	Class II	NeuMoDx Cartridge	NeuMoDx Molecular Inc
2021-07-07	Z-1979-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1980-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1981-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1982-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1983-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1984-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1985-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1986-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1987-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1988-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1989-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1990-2021	Class II	Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option	Philips North America Llc
2021-07-07	Z-1991-2021	Class II	5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions…	Bard Access Systems Inc.
2021-07-07	Z-1993-2021	Class II	PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit	Smiths Medical ASD Inc.
2021-07-07	Z-1994-2021	Class II	5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm…	Bard Access Systems Inc.
2021-07-07	Z-1995-2021	Class II	MaxPlusTM bi fuse extension set with 2 clear needleless connectors	CAREFUSION
2021-07-07	Z-1996-2021	Class II	Physician Order Form	Flowonix Medical Inc
2021-07-07	Z-1997-2021	Class II	Tempus Pro	Remote Diagnostic Technologies Ltd.
2021-06-30	Z-1863-2021	Class I	GENOSYL DS	Vero Biotech, LLC
2021-06-30	Z-1901-2021	Class II	Sapi Med sterile disposable colorectal anoscopes and proctoscopes	Adler MicroMed, Inc.
2021-06-30	Z-1902-2021	Class II	Ventec Life Systems VOCSN Multi-Function Ventilator…	Ventec Life Systems, Inc.
2021-06-30	Z-1903-2021	Class II	BioFire BCID2 Panel	BioFire Diagnostics, LLC
2021-06-30	Z-1904-2021	Class II	Philips Allura Xper System: Interventional Fluoroscopic X-Ray System…	Philips Medical Systems Nederlands
2021-06-30	Z-1905-2021	Class II	Access SARS CoV-2 lgG II Reagent	Beckman Coulter Inc.
2021-06-30	Z-1906-2021	Class II	Access SARS-CoV-2 lgG II Calibrator	Beckman Coulter Inc.
2021-06-30	Z-1907-2021	Class II	Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic…	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1908-2021	Class II	Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic…	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1909-2021	Class II	6" x 48" Elastic Poly Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1910-2021	Class II	6" x 96" Elastic Poly Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1911-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1912-2021	Class II	6" x 48" Elastic Poly Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1913-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1914-2021	Class II	Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item…	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1915-2021	Class II	Transducer Cover 15x147cm	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1916-2021	Class II	Transducer Cover 18x147cm	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1917-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1918-2021	Class II	Hays Ultrasound kit Item ID: H1000SE	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1919-2021	Class II	Hays Innovation Ultrasound Probe Cover Kit	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1920-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1921-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1922-2021	Class II	Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1923-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1924-2021	Class II	Probe Cover	Exact Medical Manufacturing, Inc.
2021-06-30	Z-1925-2021	Class II	reSET Mobile App	Pear Therapeutics, Inc.
2021-06-30	Z-1926-2021	Class II	reSET-O Mobile App	Pear Therapeutics, Inc.
2021-06-30	Z-1927-2021	Class II	Case Cardiac Assessment System for Exercise Testing and CardioSoft…	GE Healthcare, LLC
2021-06-30	Z-1929-2021	Class II	FREESTYLE LANCETS 28G 100CT Item Number:2975670	Cardinal Health Inc.
2021-06-30	Z-1930-2021	Class II	FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM	Cardinal Health Inc.
2021-06-30	Z-1931-2021	Class II	FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877	Cardinal Health Inc.
2021-06-30	Z-1932-2021	Class II	AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033	Cardinal Health Inc.
2021-06-30	Z-1933-2021	Class II	BD UF PEN 32GX4MM 100 NANO Item Number: 4292272	Cardinal Health Inc.
2021-06-30	Z-1934-2021	Class II	DEXCOM G6 SENSOR 3 PACK Item Number: 5447552	Cardinal Health Inc.
2021-06-30	Z-1935-2021	Class II	VAPORIZER VICKS 1	Cardinal Health Inc.
2021-06-30	Z-1936-2021	Class II	ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174	Cardinal Health Inc.
2021-06-30	Z-1937-2021	Class II	ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788	Cardinal Health Inc.
2021-06-30	Z-1938-2021	Class II	ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443	Cardinal Health Inc.
2021-06-30	Z-1939-2021	Class II	ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610	Cardinal Health Inc.
2021-06-30	Z-1940-2021	Class II	ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628	Cardinal Health Inc.
2021-06-30	Z-1941-2021	Class II	OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326	Cardinal Health Inc.
2021-06-30	Z-1942-2021	Class II	ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862	Cardinal Health Inc.
2021-06-30	Z-1943-2021	Class III	inLight Medical LED Pads used with Polychromatic light technology…	Inlightened Partners LLC
2021-06-30	Z-1944-2021	Class II	FilmArray Pneumonia Panel	BioFire Diagnostics, LLC
2021-06-30	Z-1945-2021	Class II	Medical Action INDUSTRIES INC	Medical Action Industries, Inc. 306
2021-06-30	Z-1946-2021	Class II	Medical Action INDUSTRIES INC	Medical Action Industries, Inc. 306
2021-06-30	Z-1947-2021	Class II	novaplus	Medical Action Industries, Inc. 306
2021-06-30	Z-1948-2021	Class II	Medical Action INDUSTRIES INC	Medical Action Industries, Inc. 306
2021-06-30	Z-1949-2021	Class II	Medical Action INDUSTRIES INC	Medical Action Industries, Inc. 306
2021-06-30	Z-1950-2021	Class II	Econocare Plus Waffle Overlay- Intended for use as a medical device…	EHOB, Inc.
2021-06-30	Z-1951-2021	Class II	LEGION Posterior Stabilized OXINIUM Femoral Component	Smith & Nephew, Inc.
2021-06-23	Z-1848-2021	Class II	Angio Pack REF: AMS6908C	Windstone Medical Packaging, Inc.
2021-06-23	Z-1849-2021	Class II	Angio Pack REF: AMS8050A	Windstone Medical Packaging, Inc.
2021-06-23	Z-1850-2021	Class II	Corin TriIFit TS SIZE 2	Corin Ltd
2021-06-23	Z-1851-2021	Class II	Corin TriFit CF SIZE 7	Corin Ltd
2021-06-23	Z-1852-2021	Class II	Hydrodissection Cannula	Anodyne Surgical
2021-06-23	Z-1853-2021	Class II	v	Abbott Laboratories Inc. (St Jude Medical)
2021-06-23	Z-1854-2021	Class II	v	Abbott Laboratories Inc. (St Jude Medical)
2021-06-23	Z-1855-2021	Class II	WorkMate Claris v	Abbott Laboratories Inc. (St Jude Medical)
2021-06-23	Z-1856-2021	Class II	Radiometer ABL90 FLEX Analyzer with E3800 PC units	Radiometer Medical ApS
2021-06-23	Z-1857-2021	Class II	Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units	Radiometer Medical ApS
2021-06-23	Z-1858-2021	Class II	E3800 PC Units	Radiometer Medical ApS
2021-06-23	Z-1859-2021	Class II	Dialysate Concentrate for Hemodialysis-Liquid/Powd	Medivators, Inc.
2021-06-23	Z-1860-2021	Class I	Angiographic Guidewire Component: Model Number: 107042	Medtronic Vascular
2021-06-23	Z-1861-2021	Class II	Skyton Bracket Flatscreen	Skytron, Div. The KMW Group, Inc
2021-06-23	Z-1862-2021	Class II	The Better-Bladder	Circulatory Technology Inc.
2021-06-23	Z-1864-2021	Class II	GE Healthcare Innova IGS 3	GE Healthcare, LLC
2021-06-23	Z-1865-2021	Class II	ACUVUE VITA soft	Johnson & Johnson Vision Care, Inc.
2021-06-23	Z-1866-2021	Class II	Electrostatic Filter Angled	Covidien, LP
2021-06-23	Z-1867-2021	Class II	Mechanical Filter with Connector Small	Covidien, LP
2021-06-23	Z-1868-2021	Class II	Adult-Pediatric Electrostatic Filter HME	Covidien, LP
2021-06-23	Z-1869-2021	Class II	HME for Tracheostomized Patients	Covidien, LP
2021-06-23	Z-1870-2021	Class II	Atellica CH 930 Analyzer with Photometer Lamp	Siemens Healthcare Diagnostics, Inc.
2021-06-23	Z-1871-2021	Class II	Medtronic HY10Z48R2	Medtronic Perfusion Systems
2021-06-23	Z-1872-2021	Class II	Medtronic HY8M63R4	Medtronic Perfusion Systems
2021-06-23	Z-1873-2021	Class II	Medtronic BB10R94R6	Medtronic Perfusion Systems
2021-06-23	Z-1874-2021	Class II	Medtronic BB11J14R2	Medtronic Perfusion Systems
2021-06-23	Z-1875-2021	Class II	Medtronic HY7M07R6	Medtronic Perfusion Systems
2021-06-23	Z-1876-2021	Class II	Medtronic CB7J97R8	Medtronic Perfusion Systems
2021-06-23	Z-1877-2021	Class II	Medtronic HY11B40R1	Medtronic Perfusion Systems
2021-06-23	Z-1878-2021	Class II	Medtronic CB1H18R20	Medtronic Perfusion Systems
2021-06-23	Z-1879-2021	Class II	Medtronic CB10W63R1	Medtronic Perfusion Systems
2021-06-23	Z-1880-2021	Class II	Medtronic HY8R62R13	Medtronic Perfusion Systems
2021-06-23	Z-1881-2021	Class II	Medtronic CB4W67R20	Medtronic Perfusion Systems
2021-06-23	Z-1882-2021	Class II	Medtronic CB10W64R1	Medtronic Perfusion Systems
2021-06-23	Z-1883-2021	Class II	Medtronic HY10J00R12	Medtronic Perfusion Systems
2021-06-23	Z-1884-2021	Class II	Medtronic CB10W65R1	Medtronic Perfusion Systems
2021-06-23	Z-1885-2021	Class II	Medtronic HY10Y54R4	Medtronic Perfusion Systems
2021-06-23	Z-1886-2021	Class II	Medtronic HY10D90R2	Medtronic Perfusion Systems
2021-06-23	Z-1887-2021	Class II	Medtronic CB10R79R6	Medtronic Perfusion Systems
2021-06-23	Z-1888-2021	Class II	Medtronic CB10R55R5	Medtronic Perfusion Systems
2021-06-23	Z-1889-2021	Class II	Medtronic CB7J98R7	Medtronic Perfusion Systems
2021-06-23	Z-1890-2021	Class II	Medtronic HY10L28R3	Medtronic Perfusion Systems
2021-06-23	Z-1891-2021	Class II	Medtronic CB10Y89R10	Medtronic Perfusion Systems
2021-06-23	Z-1892-2021	Class II	Medtronic BB8M63R5	Medtronic Perfusion Systems
2021-06-23	Z-1893-2021	Class II	Medtronic BB7D76R13	Medtronic Perfusion Systems
2021-06-23	Z-1894-2021	Class II	Medtronic BB9G78R8	Medtronic Perfusion Systems
2021-06-23	Z-1895-2021	Class II	Medtronic 1A46R11	Medtronic Perfusion Systems
2021-06-23	Z-1896-2021	Class II	OSSUR MIAMI J SELECT COLLAR	Ossur Americas
2021-06-23	Z-1897-2021	Class II	VENOVO Venous Stent System 10F Product Description	Bard Peripheral Vascular Inc
2021-06-23	Z-1898-2021	Class II	VENOVO Venous Stent System 8F Product Description	Bard Peripheral Vascular Inc
2021-06-23	Z-1899-2021	Class II	VENOVO Venous Stent System 9F Product Description	Bard Peripheral Vascular Inc
2021-06-16	Z-1537-2021	Class I	COVID-19 Self-Test Kit * INNOVA * 7T	INNOVA MEDICAL GROUP, INC.
2021-06-16	Z-1538-2021	Class I	For In Vitro Diagnostic Use Only * 25T 888 SARS-CoV-2 Antigen *…	INNOVA MEDICAL GROUP, INC.
2021-06-16	Z-1539-2021	Class I	COVID-19 Self-Test Kit * INNOVA * 3T	INNOVA MEDICAL GROUP, INC.
2021-06-16	Z-1784-2021	Class I	ADULT CHEST TUBE TRAY	Avid Medical, Inc.
2021-06-16	Z-1785-2021	Class I	FISTULA ON-OFF KIT	Avid Medical, Inc.
2021-06-16	Z-1786-2021	Class I	FISTULA	Avid Medical, Inc.
2021-06-16	Z-1787-2021	Class I	DIALYSIS ACCESS Medical convenience kit	Avid Medical, Inc.
2021-06-16	Z-1794-2021	Class II	WishBone Medical Plate and Screw System	Wishbone Medical, Inc.
2021-06-16	Z-1795-2021	Class II	Ingenia Ambition X	Philips North America Llc
2021-06-16	Z-1796-2021	Class II	Ingenia Ambition S	Philips North America Llc
2021-06-16	Z-1797-2021	Class II	Braive Growth Modulation System Break-Off Set Screws	Medtronic Sofamor Danek USA, Inc
2021-06-16	Z-1798-2021	Class I	JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1	Smiths Medical ASD Inc.
2021-06-16	Z-1799-2021	Class II	Atec Insignia Anterior Cervical Plate System	Alphatec Spine, Inc.
2021-06-16	Z-1800-2021	Class II	Atec Insignia Anterior Cervical Plate System	Alphatec Spine, Inc.

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