8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ADD-1
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191087·AK3 Flat Insert Trial Size 1-3 - 14mm
COAGULATION FACTOR DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
FDA 510(k)
FDA Class 1
·Immunology
MONOPOLAR CAUTERY INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 2, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 24, 2012
PERFECTO2 V WITH SENSOR 9153650799
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 15, 2015
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024