61 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
AcoSound. Model Number: LW12-BTE-M
FDA Recall
Open, Classified
·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.·Product code QUG·April 25, 2025
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
FDA Recall
Open, Classified
·Oxoid Limited Wade Road Basingstoke United Kingdom·Product code JTN·December 23, 2024
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·November 19, 2015
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657and 231658
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607; 5 ug, Catalog No. 291308
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
FDA Recall
Terminated
·Hardy Diagnostics·Product code JSO·June 26, 2015