7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
FDA 510(k)
FDA Class 2
·Clinical Chemistry
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
FDA 510(k)
FDA Class 2
·Orthopedic
KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 10, 2012
FMP HIP
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code LPH·June 23, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021