8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106990·MAUMENEE TYING FORCEPS ANGLED
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
FDA 510(k)
FDA Class 2
·Anesthesiology
DIAGNOSTIC REAGENT PET-RPLA
FDA 510(k)
FDA Class 1
·Microbiology
STRAITSHOT AORTIC CANNULA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·February 11, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 10, 2011
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013
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