11 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYN·July 22, 2021
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
FDA Enforcement
Class II
·Completed·Bio-Rad Labs·May 6, 2020
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
FDA Recall
Completed
·Bio-Rad Labs·Product code MVM·April 3, 2019
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
FDA Enforcement
Class II
·Completed·SCIENCE & BIO MATERIALS·July 20, 2022
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
FDA Recall
Completed
·Epimed International·Product code BSO·December 28, 2017
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
FDA Recall
Completed
·Epimed International·Product code BSO·December 28, 2017
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Recall
Completed
·Greiner Bio-One North America, Inc.·Product code JKA·March 31, 2023
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Enforcement
Class II
·Completed·Greiner Bio-One North America, Inc.·May 24, 2023
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
FDA Recall
Completed
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·April 24, 2024
AggreGuide A-100 Instrument
FDA Recall
Completed
·Aggredyne, Inc.·Product code JOZ·July 23, 2019
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
FDA Recall
Completed
·SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France·Product code HWC·October 7, 2021