8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MICRO-AIRE REPLACEMENT SURG. SAW BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Graftys Quickset
FDA 510(k)
FDA Class 2
·Orthopedic
INION TRINION BIODEGRADABLE MENISCUS SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 26, 2014
UNKNOWN PEGGED TIBIAL COMPONENT SIZE 3
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·November 9, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2015
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017