19 results
·
27ms
·
Sources: EU EUDAMED, US FDA
GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601419·SOD CANN FXD 5.0MM SNGL VLV OPP DOV
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756086622·IMMOBILIZER
SCANLAN® Dilators
FDA UDI
SCANLAN INTERNATIONAL INC·00846159031461·Garrett Vascular Dilator
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BONE PLUS BCP
FDA 510(k)
FDA Class 2
·Dental
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B16790095000010·
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B16790095000030·
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B16790095000020·
CURE LP
FDA UDI
MEDITECH SPINE, LLC·B16790095000040·
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·December 10, 2014
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·April 11, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 27, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FNL·November 10, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 9, 2016
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