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Data / Medical devices / United States / Intl. Medsurg Connection, Inc.

Intl. Medsurg Connection, Inc.: FDA-registered device maker in Schaumburg, IL, United States, 15 510(k) clearances

Intl. Medsurg Connection, Inc. is registered with the FDA (registration 1423625) in Schaumburg, IL, United States. It lists 13 device types. The FDA files 15 510(k) clearances under its listings, the newest dated August 18, 2011. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1423625
FEI number
3000210101
Address
935 N Plum Grove Rd Ste F, Schaumburg, IL, United States, 60173
Owner or operator
INTL. MEDSURG CONNECTION, INC. (9028111)
Roles
Specification developer
First device listed
February 5, 2002
Registered through
2026
Brand names listed
Basin; Convenience Bag, IMC SURGICAL GOWNS, IMC SYRINGE PISTON, IMC Surgical facemask, Syringe & Needle Hypodermic, single

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Specification developeraccessdata.fda.gov
Basin, EmesisFNY1Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
Cover, Barrier, ProtectiveMMP2Specification developeraccessdata.fda.gov
Device, General Purpose, Microbiology, DiagnosticLIB1Specification developeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Specification developeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Specification 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
August 18, 2011K110882IMC INSULIN SYRINGEFMFSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
August 18, 2011K110656IMC BLOOD COLLECTION NEEDLEFMISubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
January 14, 2011K102584IMC HYPODERMIC NEEDLEFMISubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
December 20, 2010K102969IMC PISTON SYRINGESFMFSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
October 5, 2010K100991IMC SURGICAL DRAPEKKXSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
August 16, 2010K100846IMC SURGICAL FACE MASKFXXSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
April 20, 2010K100208IMC SURGICAL DRAPEKKXSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
November 17, 2005K052550IMC SURGICAL GOWNSFYASubstantially EquivalentIntl. Medsurg Connection, Inc.accessdata.fda.gov
November 17, 2005K052169IMC SURGICAL DRAPESKKXSubstantially EquivalentInternational Medsurg Connection, Inc.accessdata.fda.gov
June 7, 2005K050538IMC DRAPESKKXSubstantially EquivalentIntl. Medsurg Connection, Inc.accessdata.fda.gov
March 11, 2005K042893UNDER BUTTOCKS DRAPEKKXSubstantially EquivalentInternational Medsurg Connection, Inc.accessdata.fda.gov
March 10, 2003K023808IRRIGATION SETSLJHSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
November 7, 2002K022159PISTON SYRINGE & HYPODERMIC NEEDLEFMFSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
February 19, 2002K014239MEDSURG EQUIPMENT COVERSMMPSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
June 24, 1997K971159SURGICAL DRAPESKKXSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 23, 201777658Class IITerminatedSyringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, trInsufficient documentation to support product sterility claims.accessdata.fda.gov
April 9, 201261681Not yet classifiedTerminated8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA; Made in China; item IMSGZX8416-10 For use to control The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.accessdata.fda.gov
August 16, 200636169Not yet classifiedTerminatedAllegiance Esmark 4' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8The bandages labeled as sterile had not been sterilized prior to distribution.accessdata.fda.gov

Compare with other makers

Updated August 18, 2011. 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.