8 results
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18ms
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Sources: EU EUDAMED, US FDA
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Senhance Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAVIGATOR APPLICATIONS SUITE
FDA 510(k)
FDA Class 2
·Anesthesiology
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 19, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 21, 2012
DR. SCHOLL'S MASSAGING GEL HEEL CUPS
FDA Adverse Event
Other
·Product code KYS·July 14, 2010
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
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