8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INJECTOR FILL TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTUNE SLEEP APNEA SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON ?11X34
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·December 19, 2012
INFINITY ACUTE CARE SYSTEM
FDA Adverse Event
Injury
·DRAEGER MEDICAL GMBH·Product code MHX·June 20, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
IN TOUCH ZX
FDA Adverse Event
STRYKER MEDICAL QUEBEC LP·Product code FNL·November 22, 2010
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 31, 2016