15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
FDA 510(k)
FDA Class 1
·Cardiovascular
Edge™ Diamond PC014-4.5C Parallel Chamfer
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172005913·Diamond dental bur, reusable
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OMIBAND
FDA 510(k)
FDA Class 1
·General Hospital
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
IMUFLEX DISPOSBLES
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code KSR·February 15, 2013
COULTER AC*T DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·January 19, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 19, 2014
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