8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ARTHROBOT(TM) WRIST HOLDER ACCESSORY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189713·LEVAMED ACTIVE ANKLE SUP BLACK L II
CHARTIS CATHETER MODEL CHR-CA-12.0
FDA 510(k)
FDA Class 2
·Anesthesiology
RESORBABLE BONE PINS
FDA 510(k)
FDA Class 2
·Orthopedic
LD304 MATERNITY BED
FDA Adverse Event
Other
·STRYKER CORP., MED DIV.·Product code HDD·November 22, 2010
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 11, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 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