10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
FDA 510(k)
FDA Class 2
·Microbiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690197980·AK3 PS-C Insert Trial Size 5, 14mm
LEONE SPA
FDA UDI
LEONE SPA·08033707065890·EXTRAORAL ELASTICS 3/8" 14 oz
DTM AGAR
FDA 510(k)
FDA Class 1
·Microbiology
FASCIA CUTTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 25, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 3, 2013
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·November 9, 2010
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025