10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BACTO STAPHYLOCOCCUS LATEX TEST
FDA 510(k)
FDA Class 1
·Microbiology
CygneX I System
FDA 510(k)
FDA Class 2
·Radiology
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
FDA 510(k)
FDA Class 2
·Orthopedic
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·January 21, 2020
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 23, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 11, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 24, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 22, 2010
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 23, 2019
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026