19 results
·
27ms
·
Sources: EU EUDAMED, US FDA
GLB VARICELLA-ZOSTER VIRUS FLUORESCENT
FDA 510(k)
FDA Class 2
·Microbiology
MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T-PIECE RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024194984·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024517875·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024195028·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024517844·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024195035·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024195011·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024517837·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024517851·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024194991·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024517820·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024195004·
Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024517868·
IMHS CP SCREW
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HWC·November 21, 2012
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 9, 2015
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 20, 2010
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