8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TOMAC STERILE DISP. LAP SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ERA® Implant Abutment Micro 0°, 6mm Cuff (BE)
FDA UDI
STERNGOLD DENTAL LLC·00841549104107·Implant retained overdentures are an establishe...
REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
TRANSRADIAL ARTERY ACCESS DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 15, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MMI·August 24, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015