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Sources: EU EUDAMED, US FDA
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Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
FDA Recall
Terminated
·Cook Endoscopy·Product code MND·June 7, 2011
Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
FDA Recall
Terminated
·Becton Dickinson & Company·Product code PND·September 14, 2020
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
FDA Recall
Terminated
·Becton Dickinson & Company·Product code PND·September 14, 2020
Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code NQD·November 11, 2015
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
FDA Recall
Terminated
·Becton Dickinson & Company·Product code PND·March 17, 2020
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP SMN:10445066
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code NQD·November 11, 2015
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Recall
Terminated
·Arrow International Inc·Product code PND·April 23, 2019
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code NQD·February 26, 2016
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
FDA Recall
Terminated
·Micro-Tech Usa·Product code MND·October 5, 2020
Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
FDA Recall
Terminated
·Cook Endoscopy·Product code MND·September 3, 2010
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
FDA Recall
Terminated
·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·Product code PND·September 24, 2019
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
FDA Recall
Terminated
·ARROW INTERNATIONAL Inc.·Product code PND·September 14, 2022
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
FDA Recall
Terminated
·Laerdal Medical (Suzhou) Co., Ltd. Science & Technology Ind. Park No.·Product code JCX·December 18, 2020
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Recall
Terminated
·MEDLINE IND·Product code KMJ·December 12, 2016
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Enforcement
Class II
·Terminated·MEDLINE IND·January 18, 2017
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
FDA Recall
Terminated
·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017
Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609.
FDA Recall
Terminated
·Bausch & Lomb·Product code LPN·April 13, 2006
BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ
FDA Recall
Terminated
·Becton Dickinson & Company·May 17, 2007
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PIC·January 14, 2019
The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191.
FDA Recall
Terminated
·Proctor & Gamble Co·Product code JEQ·February 23, 2005