10 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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
TRI-TECH INC. CUSTOM BLOOD ALCOHOL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Betel Gloves Nitrile Examination Glove Powder Free
FDA 510(k)
FDA Class 1
·General Hospital
EZ-SCOPE AN, EZ-SCOPE LIGHT
FDA 510(k)
FDA Class 1
·Radiology
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·January 11, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
DUAL TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·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