10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANATOMIC TOE SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210819·
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK
UROLOGICAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELECSYS T3 CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·June 25, 2014
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 11, 2013
IN TOUCH ZU
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