10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
POWERED TREADMILL (20/ST)
FDA 510(k)
FDA Class 1
·Physical Medicine
Ceramill
FDA UDI
Amann Girrbach AG·E4947610401·
Daytona® Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981149666·Precontoured Rod, 4.5 x 40mm
TEST, MONO., CARD (MACRO-VUE)
FDA 510(k)
FDA Class 2
·Immunology
BANDAGE, WRINKY-LASTIC ELASTIC GAUZE
FDA 510(k)
FDA Class 1
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
1 MODULE CORE WITH ISE600
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·July 19, 2007
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 26, 2012
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024