23 results · 11ms · Sources: EU EUDAMED, US FDA

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AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

FDA Enforcement
Class II ·Terminated·Applied Medical Technology Inc·April 20, 2016

Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.

FDA Recall
Terminated ·Sun Med, Inc.·Product code CCW·April 27, 2007

Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880

FDA Recall
Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JGJ·November 13, 2020

Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

FDA Recall
Terminated ·Abbott Laboratories Diagnostic Div·Product code JGJ·December 22, 2003

VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JGJ·June 12, 2013

Magnesium on RX Imola analyser IVD

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JGJ·April 14, 2016

ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code CGJ·March 5, 2018

ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGJ·August 7, 2012

Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

FDA Recall
Terminated ·Selectivemed Components Inc·Product code EGJ·March 15, 2005

Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code CGJ·November 5, 2012

Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JGJ·February 17, 2012

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).

FDA Recall
Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code JGJ·August 11, 2014

ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code JGJ·January 2, 2019

DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

FDA Recall
Terminated ·PerkinElmer Health Sciences, Inc.·Product code CGJ·November 16, 2016

iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

FDA Recall
Terminated ·Tapemark Company·Product code EGJ·November 10, 2021

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code JGJ·December 8, 2021

Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JGJ·September 30, 2015

Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326

FDA Recall
Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JGJ·November 13, 2020

Hidrex USA DVP1000

FDA Recall
Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

Hidrex USA DP450

FDA Recall
Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017