10 results
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20ms
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Sources: EU EUDAMED, US FDA
OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XPOD/XMAP NERVE STIMULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Reprocessed Shavers/Burs
FDA 510(k)
FDA Class 2
·Orthopedic
CC TIBIAL INSERT SZ 3, 18MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 5, 2024
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 13, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 14, 2010
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 13, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017