9 results
·
33ms
·
Sources: EU EUDAMED, US FDA
SALIVA SUBSTITUTE
FDA 510(k)
FDA Unclassified
·Unknown
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229710·Tranquil-L ALIF Trial 18x36x28, 6 deg
MICROHYBRID 11
FDA 510(k)
FDA Class 2
·Dental
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
8MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·May 21, 2014
LABRAFIX SPEEDLOCK PLUS IMPLANT SET WITH MAGNU
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·October 23, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 6, 2015
BW Webster Duo-Decapolar, Product Number D728260RT; 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