7 results
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25ms
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Sources: EU EUDAMED, US FDA
HOME AMB-ALERT
FDA 510(k)
FDA Class 1
·General Hospital
SLEEPER MASK SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MED-OPEDIC SLEEP SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·January 11, 2013
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 3, 2010
UNKNOWN DEPUY LOCKING RING
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 15, 2014
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