27 results · 18ms · Sources: EU EUDAMED, US FDA

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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