13 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
FDA Recall
Open, Classified
·Epitope Diagnostics, Inc.·Product code QKO·October 1, 2020
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Recall
Open, Classified
·Wright Medical Technology, Inc.·Product code HRS·April 10, 2023
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Recall
Open, Classified
·Wright Medical Technology, Inc.·Product code HRS·April 10, 2023
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
FDA Recall
Open, Classified
·Edge Biologicals Inc·Product code QMC·October 2, 2023
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.
FDA Recall
Open, Classified
·GRAPHENANO DENTAL SL Calle De Pau Casals·Product code EBI·October 24, 2023
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
FDA Recall
Open, Classified
·Keystone Industries·Product code EBI·April 10, 2023
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
FDA Recall
Open, Classified
·G & H Wire Company·Product code ECI·December 21, 2023
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBI·January 6, 2022
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBI·January 6, 2022