12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS SYSLOC A.V.FISTULA NEEDLE SET
FDA UDI
JMS SINGAPORE PTE LTD·08888483005437·SYSLOC AVF 17GX11/4" BE 30CM W/CLAMP
CONMED LINVATEC SMART GUARD IRRIGATOR
FDA 510(k)
FDA Class 2
·Orthopedic
SUDOSCAN
FDA 510(k)
FDA Class 2
·Neurology
TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 27, 2024
FORTIFY VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·July 5, 2011
LCP BEND-IRON F/RECOPL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXP·June 14, 2013
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021
TERUMO PROGREAT CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024