Intl. Medsurg Connection, Inc.
Schaumburg, IL, US
INTL. MEDSURG CONNECTION, INC. appears in FDA device records in Schaumburg, IL. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 65 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Intl. Medsurg Connection, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- International Medsurg Connection, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Intl. Medsurg Connection, Inc. between 1997 and 2011. The busiest year on record is 2005, with 4. The most recent is 2011, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2005 | 4 |
| 2010 | 4 |
| 2011 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110882 | IMC INSULIN SYRINGE | FMF | Substantially Equivalent | |
| K110656 | IMC BLOOD COLLECTION NEEDLE | FMI | Substantially Equivalent | |
| K102584 | IMC HYPODERMIC NEEDLE | FMI | Substantially Equivalent | |
| K102969 | IMC PISTON SYRINGES | FMF | Substantially Equivalent | |
| K100991 | IMC SURGICAL DRAPE | KKX | Substantially Equivalent | |
| K100846 | IMC SURGICAL FACE MASK | FXX | Substantially Equivalent | |
| K100208 | IMC SURGICAL DRAPE | KKX | Substantially Equivalent | |
| K052550 | IMC SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K052169 | IMC SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K050538 | IMC DRAPES | KKX | Substantially Equivalent | |
| K042893 | UNDER BUTTOCKS DRAPE | KKX | Substantially Equivalent | |
| K023808 | IRRIGATION SETS | LJH | Substantially Equivalent | |
| K022159 | PISTON SYRINGE & HYPODERMIC NEEDLE | FMF | Substantially Equivalent | |
| K014239 | MEDSURG EQUIPMENT COVERS | MMP | Substantially Equivalent | |
| K971159 | SURGICAL DRAPES | KKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1423625 | 3000210101 | INTL. MEDSURG CONNECTION, INC. | 935 N Plum Grove Rd Ste F, Schaumburg, IL 60173 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- FNYBasin, Emesis
- KMEBedding, Disposable, Medical
- MMPCover, Barrier, Protective
- LIBDevice, General Purpose, Microbiology, Diagnostic
- KKXDrape, Surgical, Antimicrobial
- GENForceps, General & Plastic Surgery
- FYAGown, Surgical
- FXXMask, Surgical
- FMINeedle, Hypodermic, Single Lumen
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- LJHSystem, Irrigation, Urological
Recall records
Showing 25 of 65| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2862-2017 | Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2861-2017 | Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2860-2017 | Piston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2859-2017 | Piston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2858-2017 | Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2857-2017 | Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2856-2017 | Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2855-2017 | Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2854-2017 | Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2853-2017 | Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2852-2017 | Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2851-2017 | Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2850-2017 | Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2849-2017 | Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case, 1,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2848-2017 | Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2847-2017 | Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2846-2017 | Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2845-2017 | Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2844-2017 | Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2843-2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2842-2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2841-2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2840-2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2839-2017 | Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated | |
| Z-2838-201 | Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/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, treatment or prevention of disease, or to affect the structure or any function of the body. | Insufficient documentation to support product sterility claims. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Intl. Medsurg Connection, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain