9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NH-2002
FDA 510(k)
FDA Class 2
·Neurology
Barco
FDA UDI
Barco NV·05415334001350·MDSC-8231 12G
PERIVAC KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
NB3D BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·January 28, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 30, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 14, 2014
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025