7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Lacriflow CL
FDA 510(k)
FDA Unclassified
·Unknown
MONARC SLING
FDA Adverse Event
Injury
·AMS·Product code OTN·June 6, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 1, 2010
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·December 12, 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