9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CHEMSTRIP URINE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EA DELTA CER INSERT 36IDX52OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 24, 2022
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 17, 2013
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010
COMPLETE SE ILIAC
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIO·July 9, 2014
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024