10 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
SMR HUMERAL HEAD Ø46 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·December 13, 2022
TSRH(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMARC FIDUCIAL MARKER
FDA 510(k)
FDA Class 2
·Radiology
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 25, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
GORE HYBRID VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·May 25, 2011
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
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