8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CREATININE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ERA® Implant Abutment Micro 0°, 4mm Cuff (AN)
FDA UDI
STERNGOLD DENTAL LLC·00841549105050·Implant retained overdentures are an establishe...
PORTA GEO TI MODEL #2004
FDA 510(k)
FDA Class 2
·Dental
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTSTART XL + DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 25, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 12, 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