9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
LAPAROSCOPIC ACCESS SHEATH SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIEMENS POLYDOROS 800
FDA 510(k)DENTAL SYRINGE APPLICATION TIP
FDA 510(k)
FDA Class 1
·Dental
STEAM STER LOCKS ORANGE
FDA Adverse Event
Injury
·AESCULAP INC·Product code KCT·October 12, 2016
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·June 6, 2014
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 11, 2010
DIGITAL RADIOGRAPHY CXDI-50G
FDA Adverse Event
Malfunction
·CANON INC.·Product code MQB·December 31, 2012
STEAM STER LOCKS ORANGE
FDA Adverse Event
Malfunction
·AESCULAP INC·Product code KCT·July 26, 2016
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021