Company ยท US
Dynarex Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2018. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EFQ | Gauze/Sponge, Internal | 4 |
| FRO | Dressing, Wound, Drug | 3 |
| CBP | Valve, Non-Rebreathing | 2 |
| FXX | Mask, Surgical | 2 |
| KMF | Bandage, Liquid | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 |
| CAN | Regulator, Pressure, Gas Cylinder | 1 |
| EZD | Catheter, Straight | 1 |
| FMG | Stopcock, I.V. Set | 1 |
| FQM | Bandage, Elastic | 1 |
| HFW | Clamp, Umbilical | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 |
| JOK | Scissors, Medical, Disposable | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KMJ | Lubricant, Patient | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| LXQ | Cup, Eye | 1 |
| LYY | Latex Patient Examination Glove | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2018 | K172266 | Dynarex Three-Way Stopcock Dynarex Corporation | FMG |
| Oct 3, 2016 | K152970 | Dynarex Xeroform Petrolatum Dressing Dynarex Corporation | FRO |
| Sep 1, 2015 | K151575 | Dynarex Eye Cups Dynarex Corporation | LXQ |
| Jun 7, 2011 | K103086 | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC Dynarex Corporation | EZD |
| Feb 16, 2011 | K102637 | DYNAREX ULTRASOUND GEL Dynarex Corporation | MUI |
| Dec 18, 2009 | K092488 | DYNAREX STERILE LUBRICATING JELLY Dynarex Corporation | KMJ |
| Jan 9, 2009 | K082863 | DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) Dynarex Corporation | KNT |
| Sep 12, 2008 | K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS Dynarex Corporation | LZA |
| Dec 22, 2005 | K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 Dynarex Corp. | CBP |
| Nov 9, 2005 | K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE Dynarex Corp. | HIB |
| Oct 17, 2002 | K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 Dynarex Corp. | FRO |
| Mar 6, 2002 | K012957 | TOWEL DRAPE, MODELS 4409, 4410 Dynarex Corp. | KKX |
| Nov 28, 2001 | K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B Dynarex Corp. | HFW |
| Jul 15, 1999 | K991695 | DYNAREX NON-WOVEN SPONGE Dynarex Corp. | KMF |
| Jul 15, 1999 | K991694 | DYNAREX DRAIN SPONGE Dynarex Corp. | KMF |
| Dec 11, 1998 | K983348 | DYNAREX TRACHEOSTOMY SPONGE Dynarex Corp. | EFQ |
| Apr 1, 1996 | K960388 | DYNAREX NON-WOVEN SPONGE Dynarex Corp. | EFQ |
| May 9, 1995 | K951660 | DYNAREX GAUZE SPONGE Dynarex Corp. | EFQ |
| Dec 22, 1993 | K933308 | DYNAREX GAUZE SPONGE OR PADS Dynarex Corp. | EFQ |
| Jan 11, 1993 | K922843 | DYNAREX SUCTION CATHETERS & KITS Dynarex Corp. | BSY |
| Jan 26, 1990 | K894686 | POWDER-FREE VINYL EXAMINATION GLOVES Dynarex Corp. | LYY |
| Aug 15, 1989 | K893334 | PREPOWDERED VINYL EXAM GLOVES Dynarex Corp. | LYZ |
| May 11, 1989 | K891586 | ORAL AIRWAY Dynarex Corp. | CAE |
| Oct 5, 1988 | K882567 | SKINCOTE Dynarex Corp. | FRO |
| Mar 4, 1986 | K855130 | TRACHEOSTOMY CARE KIT Dynarex Corp. | BTO |
| Jan 24, 1986 | K855132 | SHAVE PREP TRAY Dynarex Corp. | MDM |
| Jan 13, 1986 | K855131 | SUTURE REMOVAL KIT Dynarex Corp. | JOK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2018 | Dynarex Corporation 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, Terminated |
CAN | None listed |
| Mar 3, 2016 | Dynarex Corporation dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only
Product Usage:containers for sample collection Terminated |
NNI | None listed |
| Jul 25, 2014 | Dynarex Corporation 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 m Terminated |
CBP | K052743 |
| Jul 20, 2004 | Dynarex Corporation 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 box Terminated |
FQM | None listed |
| Feb 25, 2003 | Dynarex Corporation 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. Terminated |
FXX | None listed |
| Feb 25, 2003 | Dynarex Corporation 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.
Produc Terminated |
FXX | None listed |