7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ZARA CHIN IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BIOSCANNER CREATININE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 11, 2013
ALENTI
FDA Adverse Event
Injury
·ARJO HOSP EQUIPMENT AB·Product code FSA·November 18, 2010
ARCHITECT C4000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·July 2, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015