7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
COAT-A-COUNT NHS-PROLACTIN KIT AND
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VYNTUS/ SENTRYSUITE PRODUCT LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOFREE
FDA 510(k)
FDA Class 1
·Dental
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 27, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 15, 2012
PENUMBRA SYSTEM REPERFUSION CATHETER 026
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·September 13, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024