9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEGIONELLA MWY SELECTIVE SUPPLEMENT
FDA 510(k)
FDA Class 1
·Microbiology
OLYMPUS KC-10 MOBILE DISINFEC-STAT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 2, 2014
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 8, 2012
PT2 GUIDE WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·September 24, 2010
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
FDA Recall
Open, Classified
·DJO, LLC·Product code IME·September 25, 2025
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022