13 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002
FDA Recall
Open, Classified
·Alcor Scientific, Inc.·Product code GKB·July 20, 2022
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578
FDA Recall
Open, Classified
·Mechatronics USA·Product code GKB·April 14, 2023
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
FDA Recall
Open, Classified
·Mechatronics USA·Product code GKB·April 14, 2023
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Recall
Open, Classified
·Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany·Product code FMH·April 4, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Recall
Open, Classified
·Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany·Product code FMH·April 4, 2025
ClubMax Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Logolas Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Burstberry Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Atom Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Spectrum Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code BRX·July 10, 2019
Maxim Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DKB·October 13, 2022
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Recall
Open, Classified
·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code CKB·April 30, 2025