7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
KING DIAGNOSTICS HEMOGLOBIN TEST
FDA 510(k)
FDA Class 2
·Hematology
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PULSEMASTER ERBIUM DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
SYNCRHOMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·August 17, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024