10 results
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62ms
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Sources: EU EUDAMED, US FDA
Q-linea AB
Manufacturer
🇸🇪 Sweden
Q-linea AB
FDA registration
Q-linea AB·2 products·🇸🇪 Sweden
ASTar BC G- Consumable kit
FDA UDI
Q-Linea AB·07350136800061·Antimicrobial Susceptibility Testing - Gram neg...
ASTar BC G- Kit software
FDA UDI
Q-Linea AB·07350136800054·Antimicrobial Susceptibility Testing - Gram neg...
ASTar Instrument
FDA UDI
Q-Linea AB·07350136800047·Antimicrobial Susceptibility Testing
ASTar BC G- Frozen insert
FDA UDI
Q-Linea AB·07350136800078·Antimicrobial Susceptibility Testing - Gram neg...
MCRYL VIO 36IN 3-0 S/A FS-1
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAN·June 9, 2021
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
FDA Recall
Open, Classified
·Abbott Laboratories, Inc·Product code MZA·February 3, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 16, 2026
145-DEG PE 36MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 9, 2025