14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
COVERAGE SPRAY HBV
FDA 510(k)
FDA Class 1
·General Hospital
TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
UNSPECIFIED CENTRAL LINE CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·February 15, 2013
M2A 38MMX58MM CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 29, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012