34 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
FDA Recall
Terminated
·Radiometer America Inc·Product code GKF·May 24, 2005
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
16 G / 5F Dual Lumen L-Cath catheter only.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath complete kit with U-Wing
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·December 19, 2019
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Recall
Terminated
·Product code GKR·February 8, 2018
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016