8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TEGASORB(TM) ULCER DRESSING, #90-XXX
FDA 510(k)
FDA Unclassified
·Unknown
IDENTITY DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 16, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 2012
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014