13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Gynescope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·June 16, 2000
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC.·Product code MUJ·July 28, 2021
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·May 16, 2019
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020
QUICKSITE LV
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code NIK·January 11, 2014
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·June 21, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 4, 2011
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC·Product code MUJ·August 25, 2021
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024