11 results
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28ms
·
Sources: EU EUDAMED, US FDA
R-800-SF
FDA 510(k)
FDA Class 1
·Radiology
ENEMA BAG SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SWEDE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EBI·May 22, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 15, 2010
AXIUM HELICAL DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·January 9, 2013
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023
TO GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
GORE-TEX® STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021
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