9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SANDARE HEMOGLOBIN CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150607·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 230mm
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY
FDA 510(k)
FDA Class 1
·Microbiology
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 13, 2014
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 12, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 10, 2010
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025