8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
RF CARD TEST & RF LIQUID TEST
FDA 510(k)
FDA Class 2
·Immunology
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
RTV DENTAL SILICONE
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MMI·October 22, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 19, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020