8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIVONA SLEEP APNEA TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
HFQ SERIES CONTROLS AND GENERATORS
FDA 510(k)
FDA Class 1
·Radiology
LANDMARK VENOUS ACCESS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 15, 2013
ACCENT DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 15, 2014
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·November 30, 2010
BD BACTEC FX, INSTRUMENT TOP, PACKAGED
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·February 22, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024