14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COX MALAR EMINENCE IMPLANTS
FDA 510(k)
FDA Class 2
·Ophthalmic
MICRO DIARY SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
GEENEN PANCREATIC STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·January 10, 2019
APTIMA HPV SCREENING ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code OYB·October 15, 2024
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·June 27, 2014
STRYKER STANDARD VIDEO CART W/ISOLATION TRANSFORMER
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·November 10, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021
ZIMMON PANCREATIC STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 16, 2020
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 1, 2014