10 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
FDA Enforcement
Class II
·Completed·GELITA MEDICAL GMBH·September 28, 2022
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
FDA Recall
Completed
·GELITA MEDICAL GMBH Uferstr. 7 Eberbach Germany·Product code LYA·July 27, 2022
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
FDA Enforcement
Class II
·Completed·Varian Medical Systems Imaging Laboratory GmbH·April 20, 2022
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JIX·October 29, 2020
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
FDA Recall
Completed
·Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland·Product code IYE·March 21, 2022