Dynarex Corp.
Medical device manufacturer in Orangeburg, NY.
27510(k) clearances
0PMA approvals
3recalls
Device types
- EFQ Gauze/Sponge, Internal 4
- FRO Dressing, Wound, Drug 3
- KMF Bandage, Liquid 2
- HFW Clamp, Umbilical 1
- FMG Stopcock, I.V. Set 1
- LXQ Cup, Eye 1
- EZD Catheter, Straight 1
- MUI Media, Coupling, Ultrasound 1
- KMJ Lubricant, Patient 1
- KNT Tubes, Gastrointestinal (And Accessories) 1
- LZA Polymer Patient Examination Glove 1
- CBP Valve, Non-Rebreathing 1
- HIB Speculum, Vaginal, Nonmetal 1
- KKX Drape, Surgical, Antimicrobial 1
- JOK Scissors, Medical, Disposable 1
- BSY Catheters, Suction, Tracheobronchial 1
- LYY Latex Patient Examination Glove 1
- LYZ Vinyl Patient Examination Glove 1
- CAE Airway, Oropharyngeal, Anesthesiology 1
- BTO Tube, Tracheostomy (W/Wo Connector) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | 03/14/2018SE |
| K152970 | Dynarex Xeroform Petrolatum DressingFRO · Traditional | 10/03/2016SE |
| K151575 | Dynarex Eye CupsLXQ · Traditional | 09/01/2015SE |
| K103086 | Dynarex Intermittent Catheters, Male, Female, PediatricEZD · Traditional | 06/07/2011SE |
| K102637 | Dynarex Ultrasound GelMUI · Traditional | 02/16/2011SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | 12/18/2009SE |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
| K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…LZA · Abbreviated | 09/12/2008SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | 12/22/2005SE |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-SMALL, 4912-MEDIUM, 4913-LARGEHIB · Traditional | 11/09/2005SE |
| K012816 | Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414FRO · Traditional | 10/17/2002SE |
| K012957 | Towel Drape, Models 4409, 4410KKX · Traditional | 03/06/2002SE |
| K012917 | Dynarex Umbilical Cord Lamp, Models 6833 and 6833-BHFW · Traditional | 11/28/2001SE |
| K991695 | Dynarex Non-Woven SpongeKMF · Traditional | 07/15/1999SE |
| K991694 | Dynarex Drain SpongeKMF · Traditional | 07/15/1999SE |
| K983348 | Dynarex Tracheostomy SpongeEFQ · Traditional | 12/11/1998SE |
| K960388 | Dynarex Non-Woven SpongeEFQ · Traditional | 04/01/1996SE |
| K951660 | Dynarex Gauze SpongeEFQ · Traditional | 05/09/1995SE |
| K933308 | Dynarex Gauze Sponge or PadsEFQ · Traditional | 12/22/1993SE |
| K922843 | Dynarex Suction Catheters & KitsBSY · Traditional | 01/11/1993SE |
| K894686 | Powder-Free Vinyl Examination GlovesLYY · Traditional | 01/26/1990SE |
| K893334 | Prepowdered Vinyl Exam GlovesLYZ · Traditional | 08/15/1989SE |
| K891586 | Oral AirwayCAE · Traditional | 05/11/1989SE |
| K882567 | SkincoteFRO · Traditional | 10/05/1988SN |
| K855130 | Tracheostomy Care KitBTO · Traditional | 03/04/1986SE |
| K855132 | Shave Prep TrayMDM · Traditional | 01/24/1986SE |
| K855131 | Suture Removal KitJOK · Traditional | 01/13/1986SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1955-2018 Class II | Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet…The device is equipped with a dial that has an inaccurate flow rate indicator. | 05/08/2018Terminated |
| Z-2057-2016 Class II | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile…Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect… | 03/03/2016Terminated |
| Z-2117-2014 Class II | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label…"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong… | 07/02/2014Terminated |