9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
WILTEK GASTRIC FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 4, 2012
BLADES, SCALPEL CARBON STEET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
POST-AURICULAR HEARING AID MODEL PE 600CHD
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 25, 2014
BLOM - SINGER
FDA Adverse Event
Other
·HELIX MEDICAL, LLC·Product code EWL·November 26, 2008
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·November 10, 2010
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020