7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
PERITONEAL INTRODUCER & SHEATH
FDA 510(k)
FDA Class 1
·Neurology
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
FDA 510(k)
FDA Class 2
·Cardiovascular
PFNA-II BLADE L80 TAN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HSB·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 20, 2007
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·October 10, 2012
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·January 15, 2014