7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10
FDA 510(k)
FDA Class 2
·Dental
TRULIGHT 5520 AND TRULIGHT 5320
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·May 14, 2013
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·May 19, 2011
NXSTAGE SYSTEM ONE
FDA Adverse Event
Malfunction
·NXSTAGE MEDICAL, INC.·Product code KDI·August 11, 2008
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