10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BICARBONATE (CO2) REAGENT-2 VIAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RIA KIT, GAMMADAB ESTRIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·June 18, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 20, 2012
POLYAXIAL HEAD 2 (PH2), UNKNOWN SIZE ROD
FDA Adverse Event
Malfunction
·THEKEN SPINE·Product code MNI·October 12, 2010
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 16, 2018