7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HARE ANY LEVEL COT
FDA 510(k)
FDA Class 2
·General Hospital
IVENT101
FDA 510(k)
FDA Class 2
·Anesthesiology
Pivot System Sterilization case
FDA 510(k)
FDA Class 2
·General Hospital
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 18, 2014
IAB: 8 FR-40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code FOS·October 8, 2010
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 20, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024