8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Nisus NPWT Canister 500-mL (CPC-500)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
FDA 510(k)
FDA Class 2
·Neurology
Perforated Baskets
FDA 510(k)
FDA Class 2
·General Hospital
ACCU-CHECK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·December 8, 2008
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 23, 2011
MOSAIQ
FDA Adverse Event
Other
·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·July 31, 2013
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
FDA Enforcement
Class II
·Ongoing·Tyber Medical·March 5, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025