8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MARLOW VERRES NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
MAGNETOM TRIO SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DWF·December 15, 2016
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 12, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 3, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·December 21, 2012
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021