9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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L582 TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Stern Snap One Piece Abutment 1mm Cuff (BG)
FDA UDI
STERNGOLD DENTAL LLC·00841549112324·The SternSnap Attachment is indicated for use w...
OSSEOTITE IRRIGATION UNIT
FDA 510(k)
FDA Class 1
·Dental
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-BERINGEN·Product code LIT·November 22, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·December 5, 2012
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 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