7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
NMI SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
Luja Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 19, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·February 8, 2013
ACCLAIM ENCORE 2.25
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·December 13, 2010
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 4, 2018