8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NEGATIVE PRESSURE VENOUS BLOOD LINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTASCAN BLADDER SCANNER, MODEL PA00146
FDA 510(k)
FDA Class 2
·Radiology
C-JAWS CERVICAL COMPRESSIVE STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
PORTASCAN
FDA Adverse Event
Malfunction
·MEDIWATCH UK LTD·Product code ITX·November 17, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 27, 2014
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·November 15, 2012
ATTAIN ABILITY STRAIGHT
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024