8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CPK COLOR TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALLOFUSE GEL AND PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 22, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 21, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 27, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 31, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025