7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DAVOL SURGICAL SUCTION IRRIGATION INSTR
FDA 510(k)
FDA Class 2
·General Hospital
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
FDA 510(k)
FDA Class 1
·General Hospital
SpassageQ
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® RAPID-D INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FPA·May 23, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 13, 2012
ULTRACISION HARMONIC SCALPEL HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·January 11, 2008
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025