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Sources: EU EUDAMED, US FDA
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Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JQA·November 23, 2020
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JQA·November 23, 2020
Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
FDA classification
FDA Class 1
·Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
AIA-900
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code KHO·August 31, 2018
CQA "StarTrack"
FDA UDI
IBA Dosimetry GmbH·EIBAE30350100·CQA "StarTrack" calibrated
GUM®
FDA UDI
SUNSTAR AMERICAS, INC.·00070942751469·RED-COTE® Plaque Disclosing Tablets
Oxygen Concentrator (J5A)
FDA 510(k)
FDA Class 2
·Anesthesiology
CURT G. JOA, INC.
FDA registration
CURT G. JOA, INC.·2 products·🇺🇸 United States
Image Quality Analyzer (IQA)
FDA 510(k)
FDA Class 2
·Radiology
NEURO DQA PHANTOM GEL
FDA UDI
INSIGHTEC LTD·07290015461207·DQA phantom (tissue mimic) gel for calibration ...
Neurolyser XR DQA Assembly
FDA UDI
FUSMobile LTD·07290019747031·
Exablate DQA Phantom Gel
FDA UDI
INSIGHTEC LTD·07290015461214·Tissue mimic phantom gel for DQA for Body appli...
J2A SLA Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Gafchromic™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065949·Blood Irradiation Indicator
Gafchromic™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065093·
SHIAN JIA MEEI ENTERPRISE CO., LTD.
FDA registration
SHIAN JIA MEEI ENTERPRISE CO., LTD.·1 product·🇹🇼 Taiwan
Shen Jia Yi Optical (Shenzhen) Ltd
FDA registration
Shen Jia Yi Optical (Shenzhen) Ltd·1 product·🇨🇳 China
DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD
FDA registration
DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD·4 products·🇨🇳 China
Jiangmen Jia Mei Medical Products Co., Ltd.
FDA registration
Jiangmen Jia Mei Medical Products Co., Ltd.·8 products·🇨🇳 China
SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED
FDA registration
SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED·2 products·🇨🇳 China