7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CELL-DYN 300 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUTORR 7 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PANORAMA CENTRAL STATION WITH TELEPACK
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·March 7, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 14, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 3, 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