9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POROUS COATED ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109045·CAPSULE STAINING CANNULA 25GA
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
FDA 510(k)
FDA Class 2
·Cardiovascular
da Vinci Xi Surgical System, da Vinci X Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 15, 2014
RELIEVA INSPIRA AIR 14X40MM BALLOON CATHETER
FDA Adverse Event
Malfunction
·ACCLARENT·Product code KTI·November 14, 2012
NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA INC.·Product code DQY·September 17, 2010
OSTYCUT BONE BIOPSY NEEDLE
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code DWO·September 7, 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