9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
ITE HEARING AID, SOUND MED AMETHYST MODEL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ICON 25 HCG (COMBO CASSETTE)
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 16, 2017
MICROFRANCE® INSTRUMENT
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·July 21, 2014
UNK COONRAD/MORREY HUMERAL IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·March 1, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 11, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024