7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PROCEDURE NO. 710-EP FOR ALK.PHOS.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GE DATEX-OHMEDA ENGSTROM CARESTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
AirStrip RPM
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
FDA Adverse Event
Injury
·ANGIOSCORE, INC.·Product code NWX·April 7, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·September 26, 2012
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 14, 2010
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012