8 results
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7ms
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Sources: EU EUDAMED, US FDA
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 14, 2017
The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·June 20, 2018
bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·August 29, 2018
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
FDA Enforcement
Class II
·Terminated·Rocket Medical Plc·December 4, 2019
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·January 21, 2026
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·February 19, 2020
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 5, 2014
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare·October 2, 2024