7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PICO MODELS 30, 50, 70
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Porcine Anorganic Bone Mineral in Delivery Applicator
FDA 510(k)
FDA Class 2
·Dental
LC SPRINT STAR
FDA 510(k)
FDA Class 2
·Anesthesiology
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·January 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 28, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 17, 2011
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