27 results
·
18ms
·
Sources: EU EUDAMED, US FDA
6-435 FILTER PAD, 5/PKG.
FDA 510(k)
FDA Class 2
·Anesthesiology
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750007103·VITROS 3600 Immunodiagnostic System - Refurbished
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780516361·CODMAN® Non Stick Mirror Finish Straight Bipola...
CODMAN
FDA UDI
Cerenovus, Inc.·10886704080664·CODMAN Non Stick Mirror Finish Straight Bipolar...
CODMAN MALIS
FDA UDI
Cerenovus, Inc.·10886704038757·CODMAN MALIS Non Stick Mirror Finish Straight B...
TQ HBA1C GEN3
FDA 510(k)
FDA Class 2
·Hematology
CLAMPFIX
FDA 510(k)
FDA Class 2
·Orthopedic
SUNBEAM
FDA Adverse Event
Injury
·SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS·Product code IRT·May 2, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 24, 2012
SMITH'S CADD CASSETTES
FDA Adverse Event
Injury
·SMITH'S MEDICAL·Product code FPA·August 11, 2010
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·October 10, 2023
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics·July 8, 2020
VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 15, 2019