8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
Air Relax
FDA 510(k)
FDA Class 2
·Physical Medicine
SCULPTURE 2.94 ER:YAG SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·June 13, 2014
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·December 13, 2012
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
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