Skip to the page
Get started – free

Data / Medical devices / United States / Welmed, Inc.

Welmed, Inc.: FDA-registered device maker in Chicago, IL, United States, 5 510(k) clearances

Welmed, Inc. is registered with the FDA (registration 3005841027) in Chicago, IL, United States. It lists 35 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 20, 2013. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Welmed, Inc.
FDA registration number
3005841027
Address
401 N Michigan Ave Ste 1200, Chicago, IL, United States, 60611
Owner or operator
Welmed, Inc. (9089540)
Roles
Specification developer
First device listed
March 15, 2007
Registered through
2026
Brand names listed
BANDAGE, BULB, Band Bags, Dome Bags and Set Up Covers, CAST PADDING, CONTAINER, SPECIMEN, NON-STERILE, COTTON, Camera, Surgical and Accessories, Catheter, Continuous Irrigation and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Specification developeraccessdata.fda.gov
Bandage, CastITG1Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Catheter, Continuous IrrigationGBQ1Specification developeraccessdata.fda.gov
ClampHXD1Specification developeraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Specification developeraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Specification developeraccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Specification developeraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Endoscopic Bite BlockMNK1Specification developeraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Specification developeraccessdata.fda.gov
General Surgery TrayLRO2Specification developeraccessdata.fda.gov
Gown, ExaminationFME1Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Specification developeraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Specification developeraccessdata.fda.gov
Restraint, ProtectiveFMQ1Specification developeraccessdata.fda.gov
Slides, MicroscopeKEW1Specification developeraccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Specification developeraccessdata.fda.gov
Suit, SurgicalFXO1Specification developeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Specification developeraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 20, 2013K130230STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLESFMFSubstantially EquivalentWuxi Yushou Medical Applicances Co., Ltd.accessdata.fda.gov
November 20, 2013K130212SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGEFMISubstantially EquivalentWuxi Yushou Medical Applicances Co., Ltd.accessdata.fda.gov
December 14, 2011K112057KDL SYRINGES AND NEEDLEFMFSubstantially EquivalentShanghai Kindly Enterprise Dev. Group Co.,accessdata.fda.gov
July 16, 2007K070936WELMED HYPODERMIC SYRINGEFMFSubstantially EquivalentWelmed, Inc.accessdata.fda.gov
May 24, 2007K070431WELMED, INC. SURGICAL GOWNSFYASubstantially EquivalentWelmed, Inc.accessdata.fda.gov

Compare with other makers

Updated November 20, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.