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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Specification developer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Specification developer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Specification developer | accessdata.fda.gov |
| Device, General Purpose, Microbiology, Diagnostic | LIB | 1 | Specification developer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | accessdata.fda.gov |
| System, Irrigation, Urological | LJH | 2 | Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 18, 2011 | K110882 | IMC INSULIN SYRINGE | FMF | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| August 18, 2011 | K110656 | IMC BLOOD COLLECTION NEEDLE | FMI | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| January 14, 2011 | K102584 | IMC HYPODERMIC NEEDLE | FMI | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| December 20, 2010 | K102969 | IMC PISTON SYRINGES | FMF | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| October 5, 2010 | K100991 | IMC SURGICAL DRAPE | KKX | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| August 16, 2010 | K100846 | IMC SURGICAL FACE MASK | FXX | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| April 20, 2010 | K100208 | IMC SURGICAL DRAPE | KKX | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| November 17, 2005 | K052550 | IMC SURGICAL GOWNS | FYA | Substantially Equivalent | Intl. Medsurg Connection, Inc. | accessdata.fda.gov |
| November 17, 2005 | K052169 | IMC SURGICAL DRAPES | KKX | Substantially Equivalent | International Medsurg Connection, Inc. | accessdata.fda.gov |
| June 7, 2005 | K050538 | IMC DRAPES | KKX | Substantially Equivalent | Intl. Medsurg Connection, Inc. | accessdata.fda.gov |
| March 11, 2005 | K042893 | UNDER BUTTOCKS DRAPE | KKX | Substantially Equivalent | International Medsurg Connection, Inc. | accessdata.fda.gov |
| March 10, 2003 | K023808 | IRRIGATION SETS | LJH | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| November 7, 2002 | K022159 | PISTON SYRINGE & HYPODERMIC NEEDLE | FMF | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| February 19, 2002 | K014239 | MEDSURG EQUIPMENT COVERS | MMP | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| June 24, 1997 | K971159 | SURGICAL DRAPES | KKX | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 23, 2017 | 77658 | Class II | Terminated | Syringe 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, tr | Insufficient documentation to support product sterility claims. | accessdata.fda.gov |
| April 9, 2012 | 61681 | Not yet classified | Terminated | 8" 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, 2006 | 36169 | Not yet classified | Terminated | Allegiance 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 60085-8 | The bandages labeled as sterile had not been sterilized prior to distribution. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Drape, Surgical, Antimicrobial
- All makers of Forceps, General & Plastic Surgery
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Basin, Emesis
- All makers of System, Irrigation, Urological
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.