7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
KING DIAGNOSTICS MAGNESIUM REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
360CAS
FDA 510(k)
FDA Class 2
·Neurology
HIPUSH HANDHELD MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·December 13, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013
QUARTET
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024