8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
BEAUSEAL
FDA 510(k)
FDA Class 2
·Dental
ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BE)
FDA UDI
STERNGOLD DENTAL LLC·00841549104053·Implant retained overdentures are an establishe...
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
FDA 510(k)
FDA Unclassified
·Unknown
SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK, INC.·Product code FOZ·April 17, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·August 10, 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