13 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYSMEX XN-SERIES
FDA 510(k)
FDA Class 2
·Hematology
Oticon
FDA UDI
Oticon A/S·05707131208781·ALTA, MINIRITE 312 WL CBE
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383504188·Gutta Percha Points is used to root canal filin...
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REPROCESSED ATHROSCOPICS BURS
FDA 510(k)
FDA Class 2
·Orthopedic
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
RESERVOIR 1.8ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 14, 2013
PROMUS ELEMENT ?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 24, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 19, 2011
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
Depuy LCS Complete RP insert; polyethylene tibial insert STD+, 10 mm; Ref 1294-05-510.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025