12 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE HUESTIS COMPU-PLOTTER
FDA 510(k)
FDA Class 2
·Radiology
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010584·Fixed, 10 electrode, CS, 2-8-2mm electrode spacing
Printed Lower ROC Pack for Herbst LR6 14mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015670·
SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
ADVANTAGE THC TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.,·Product code CBK·May 7, 2014
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 4, 2013
TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 12, 2010
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021