10 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Recall
Terminated
·Sterling Diagnostics, Inc.·Product code CIQ·July 20, 2016
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code LIQ·January 25, 2022
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
FDA Recall
Terminated
·HemoCue AB Kuvettgaten 1 Angelholm Sweden·Product code JIQ·November 7, 2012
Premier Rotaclone, Rx only
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code LIQ·December 1, 2021