8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DRESSING SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229870·Tranquil-L ALIF Trial 18x40x31, 12 deg
STEALTH 360 ORBITAL PAD SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General Hospital
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 7, 2012
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·June 6, 2015
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026