8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AQUEOUS BLOOD GAS CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ERA® Implant Abutment Micro 0°, 5mm Cuff (BE)
FDA UDI
STERNGOLD DENTAL LLC·00841549104091·Implant retained overdentures are an establishe...
Inno-Pathwire
FDA 510(k)
FDA Class 2
·Cardiovascular
GSIBP BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 15, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 16, 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