7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCEDURE PACKS CONTRAST MEDIA SETS
FDA 510(k)
FDA Class 2
·Cardiovascular
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·February 28, 2013
PEEL-AWAY DENNY SHEATH INTRODUCER SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·February 4, 2011
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 24, 2014
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021