10 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
PUREFLUX-H HEMODIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010
HELIOS 3000 TRACK MOUNTED LIGHT
FDA Adverse Event
Injury
·PELTON & CRANE·Product code EAZ·January 11, 2013
LOANER CORE SUMEX DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·July 9, 2014
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016