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Dynarex Corp.

US

Last updated September 17, 2026

Information

Country
US
Address
11 Dynarex Drive, Middletown, NY, 10941
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2431014
DUNS Number
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Catalogue (2572)

Page 15 of 52
DeviceModel / ReferenceRegistriesClassStatus
SecureSafe Syringe With Safety Needle 8920
FDA UDI
Class IIActive
Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock 7003
FDA UDI
Class IIActive
SiliGentle Non-Adhesive Silicone Foam Dressing 3056
FDA UDI
Class IActive
DynaSafety Blue Metal Detectable Woven Fingertip Bandages Sterile 3762-25
FDA UDI
Class IActive
Chrome With Textured Grip Grab Bar - 24" 10303
FDA UDI
Class IActive
Syringe w/Needle, Non-Toxic, 22G x 1 1/2", Luer Lock 7000
FDA UDI
Class IIActive
Suction Tubing w/Straw Connector 4686
FDA UDI
Class IIActive
Air Mattress, Dial Operated Pump, w/Bubble Pad 10440
FDA UDI
Class IIActive
DynaRest Multi-Zone Foam Mattress 10420
FDA UDI
Class IActive
Composite Headboard and Footboard 12920
FDA UDI
Class IIActive
Surgical Face Mask with Ties 2205
FDA UDI
Class IIActive
Elastic Bandages 3666
FDA UDI
Class IActive
Endotracheal Tubes 4551
FDA UDI
Class IIActive
LabChoice Cryogenic Tubes, With Graduated Markings, 5mL, Sterile 42401
FDA UDI
Class IActive
LabChoice Universal Pipette Tips, With Filter, Transparent, 10-200 uL, Sterile 40173
FDA UDI
Class IActive
Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve 36391
FDA UDI
Class IActive
Nebulizer Kit 5601
FDA UDI
Class IIActive
Syringe w/Needle 7013
FDA UDI
Class IIActive
Resp-O2 Compressor Nebulizer Plus 5618
FDA UDI
Class IIActive
Dynarex ActiSplint 3504
FDA UDI
Class IActive
Bariatric Air Cushions 10671
FDA UDI
Class IActive
Resp-O2 Small Volume Nebulizer 6cc Cup 34105
FDA UDI
Class IIActive
Ever-Soft Positioning Wedge 13002
FDA UDI
Class IActive
DynaFoam Waterproof Bordered Foam Dressing 3038
FDA UDI
Class IActive
Wheelchair anti-tipper - For S1, S2 and bariatric 10267
FDA UDI
Class IActive
Wood Applicator 4323
FDA UDI
Class IActive
Infant MPR 5801
FDA UDI
Class IIActive
LabChoice 24-Hour Urine Collection Container, 3000 mL 43029
FDA UDI
Class IActive
Arm Sling 4351
FDA UDI
Class IActive
Geri-Chair Infinite Position Recliner 10528
FDA UDI
Class IActive
DispoSafety Medical Waste Biohazard Bags, 24" x 25.6", 1.18 MIL, 12 Gallon 43201
FDA UDI
Class IActive
Ever-Soft Foam Cushion 10653
FDA UDI
Class IActive
Compress Gauze Roll Bandage 3197
FDA UDI
Class IActive
CSR Wraps 4448
FDA UDI
Class IIActive
Medi-Cut Scalpel 4115
FDA UDI
Class IActive
Resp-O2 Breathable-Foam Trach Tube Holder, 2PC, Adult, Maximum Neck Size 19.5"/50cm 35034
FDA UDI
Class IActive
Resp-O2 Heat Moisture Exchanger (HMEF) 1000 B/V CO2 Flex Tube 30101
FDA UDI
Class IIActive
Wheelchair Anti-tipper for S3, S4 10268
FDA UDI
Class IActive
Sensi-Wrap, Self Adherent 3181
FDA UDI
Class IActive
Lab Coats Knitted Cuffs & Collar Without Pockets, 2X-Large, Blue 1996
FDA UDI
Class IActive
Panty Liner 1335
FDA UDI
Class IActive
Sensi-Wrap, Self Adherent 3213
FDA UDI
Class IActive
Stretch Gauze Bandage Roll, Non-Sterile 3106
FDA UDI
Class IActive
Impression Trays 2224
FDA UDI
Class IActive
High Volume Evacuator Tip 2215
FDA UDI
Class IActive
Closed Circuit Foley Catheter Tray 5004
FDA UDI
Class IIActive
Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, 2.5 mm 36296
FDA UDI
Class IActive
SiliGentle Non-Adhesive Silicone Foam Dressing 3057
FDA UDI
Class IActive
Stretch Gauze Bandage Roll, Sterile 3113
FDA UDI
Class IActive
Coats Knitted Cuffs & Collar Without Pockets, X-Large, White 1985
FDA UDI
Class IActive

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
May 8, 2018Z-1955-2018—terminated

The device is equipped with a dial that has an inaccurate flow rate indicator.

Mar 3, 2016Z-2057-2016—terminated

Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.

Jul 2, 2014Z-2117-2014—terminated

"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.

May 10, 2004Z-0951-04—terminated

Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.

Dec 31, 2002Z-0573-03—terminated

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.

Dec 31, 2002Z-0572-03—terminated

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.