9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
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
CIRCUITGUARD CIRCUITGUARD HME
FDA Adverse Event
Other
·ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE·Product code BYD·July 20, 2005
DEVILBISS DV5M SMARTLINK SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CT GAMMA DIALYZER (CT190G)
FDA Adverse Event
Injury
·NIPRO CORPORATION·Product code KDI·June 4, 2007
MARLEX
FDA Adverse Event
Injury
·NA·Product code FTL·February 3, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 5, 2014
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021