384 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
FDA Enforcement
Class II
·Ongoing·Hycor Biomedical Inc·August 14, 2019
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·January 12, 2022
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·January 21, 2015
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·June 6, 2018
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
FDA Enforcement
Class II
·Ongoing·Turbett Surgical, Inc.·February 8, 2023
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
FDA Enforcement
Class II
·Ongoing·Turbett Surgical, Inc.·February 8, 2023
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
FDA Enforcement
Class II
·Terminated·GE Healthcare·May 14, 2014
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 18, 2015