7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI
FDA 510(k)
FDA Class 2
·General Hospital
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
FDA 510(k)
FDA Class 2
·Dental
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·January 22, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·December 3, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 15, 2014
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