9 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
FDA Enforcement
Class II
·Terminated·Dynarex Corporation·August 6, 2014
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
FDA Recall
Terminated
·Dynarex Corporation·Product code CBP·July 2, 2014
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
FDA Recall
Terminated
·Dynarex Corporation·Product code NNI·March 3, 2016
Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 12 boxes are placed into one shipping carton/case.
FDA Recall
Terminated
·Dynarex Corporation·Product code FXX·December 31, 2002
Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 4 boxes are placed into one shipping carton/case.
FDA Recall
Terminated
·Dynarex Corporation·Product code FXX·December 31, 2002
100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt.
FDA Recall
Terminated
·Dynarex Corporation·Product code FQM·May 10, 2004
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
FDA Recall
Terminated
·Dynarex Corporation·Product code CAN·May 8, 2018
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
FDA Enforcement
Class II
·Terminated·Dynarex Corporation·July 6, 2016
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
FDA Enforcement
Class II
·Terminated·Dynarex Corporation·June 6, 2018