10 results
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26ms
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Sources: EU EUDAMED, US FDA
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209129003·
Colored Chain
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746058295·CHAIN PLASTIC 15' LONG LIME
Colored Chain
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746033070·CHAIN PLASTIC 15' LONG LIME
LABIAL CUSPID TUBE
FDA 510(k)
FDA Class 1
·Dental
CARDIOSTAT 1 ECG RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
GATEWAY BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·October 5, 2010
PINNACLE MTL INS NEUT28IDX48OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD·Product code KWA·December 3, 2012
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·June 6, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024