Dynarex Corporation
Dynarex Corporation holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2018, with 3 FDA device recalls on record.
Top product codes for Dynarex Corporation
FDA recalls by Dynarex Corporation
- Z-1955-2018 — 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.
- Z-2057-2016 — dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
- Z-2117-2014 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Dynarex Corporation
- K172266 — Dynarex Three-Way Stopcock
- K152970 — Dynarex Xeroform Petrolatum Dressing
- K151575 — Dynarex Eye Cups
- K103086 — DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
- K102637 — DYNAREX ULTRASOUND GEL
- K092488 — DYNAREX STERILE LUBRICATING JELLY
- K082863 — DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
- K081569 — DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
Data sourced from openFDA. This site is unofficial and independent of the FDA.