7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTIMAX POWDER FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
FiAPC plus probes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 5, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 2, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 18, 2014
Colonoscope, Model Number PCF-H190DL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024