14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
HARBOR CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MAJOR.BASE 20
FDA 510(k)
FDA Class 2
·Dental
SERUM, CREATININE DETERMINATIONS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
ITREL II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 22, 2008
ITREL II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 22, 2008
ITREL II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 22, 2008
ITREL II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 22, 2008
ITREL II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 22, 2008
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM COMPANY·Product code IXR·May 15, 2014
PARADYM
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code MRM·October 8, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 20, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024