23 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RUGBY
FDA UDI
Rugby Laboratories·80305369995124·Premium Lubricated Latex Condoms 1 each
RUGBY
FDA UDI
Rugby Laboratories·00880681034002·Rugby Sheer Adhesive Bandages 3/4in x 3in 200 each
RUGBY
FDA UDI
Rugby Laboratories·00305361119324·Rugby Sheer Adhesive Bandages 3/4in x 3in 200 each
INSULIN SYRINGE
FDA Adverse Event
RUGBY LABORATORIES·Product code FMF·May 8, 1996
INSULIN SYRINGE
FDA Adverse Event
Malfunction
·RUGBY LABORATORIES, INC.·Product code FMF·January 13, 1995
INSULIN SYRINGE, 0.3 CC, U-1000
FDA Adverse Event
RUGBY LABORATORIES, INC.·Product code FMF·December 9, 1994
SINGLE USE INSULIN SYRINGE
FDA Adverse Event
Other
·RUGBY LABORATORIES, INC.·Product code FMF·December 2, 1996
INSULIN SYRINGE
FDA Adverse Event
Malfunction
·RUGBY LABORATORIES, INC.·Product code FMF·October 25, 1999
RELIANCE 4-FRONT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·July 8, 2021
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·March 15, 2017
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·March 18, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·March 18, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·March 18, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·March 18, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·March 18, 2025
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·February 13, 2017
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·November 17, 2008
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·October 19, 2023
CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·April 16, 2010
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·February 12, 2009