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Sign in to claim this brandINTEGRATED MEDICAL SYSTEMS, INC.
US
Last updated May 23, 2026
What INTEGRATED MEDICAL SYSTEMS, INC. makes
Integrated Medical Systems, Inc. makes medical devices including elastomeric infusion pump systems, basic intravenous administration sets, general-purpose syringes, intravenous administration bags and bottles, vascular catheterization support and maintenance kits, and percutaneous catheter protectors.
The company's portfolio is regulated under Class I, Class II, and U device classes and is listed in the FDA 510(k) and FDA UDI registries, with the company based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of products does Integrated Medical Systems, Inc. manufacture?
The company makes medical devices such as elastomeric infusion pump systems and basic intravenous administration sets, which are used for various medical purposes, as indicated in their device categories.
Where is Integrated Medical Systems, Inc. based?
The company is based in the US, as indicated in their country of origin.
Which registries list Integrated Medical Systems, Inc.'s devices?
The company's devices are listed in the FDA 510(k) and FDA UDI registries, which track medical devices.
How are Integrated Medical Systems, Inc.'s devices classified?
The devices are classified under Class I, Class II, and U device classes, which determine the level of regulatory control.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 962364444
Catalogue (72)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IMed Products | IM250250S | FDA UDI | Class II | Active |
| Integrated Medical Specialties | IMS001 | FDA UDI | Class II | Active |
| IMed Products | IM68055 | FDA UDI | Class II | Active |
| IMed Products | IM400200S | FDA UDI | Class II | Active |
| IMed Products | IM68135 | FDA UDI | Class II | Active |
| IMed Products | IM1250 | FDA UDI | Class I | Active |
| IMed Products | IM68045 | FDA UDI | Class II | Active |
| IMed Products | IM36026 | FDA UDI | U | Active |
| IMed Products | IM400100S | FDA UDI | Class II | Active |
| IMed Products | IM300006C | FDA UDI | Class II | Active |
| IMed Products | IM68125 | FDA UDI | Class II | Active |
| IMed Products | IM500020L | FDA UDI | Class II | Active |
| IMed Products | IM68110 | FDA UDI | Class II | Active |
| IMed Products | IM100200S | FDA UDI | Class II | Active |
| IMed Products | IM250500S | FDA UDI | Class II | Active |
| Calibration Reference I & Ii | K855035 | FDA 510(k) | Class I | Active |
| Life Support For Trauma And Trnsport (lstat) G6 Lite | K082256 | FDA 510(k) | Class II | Active |
| Chemistry Control N & A | K855036 | FDA 510(k) | Class I | Active |
| Multimed (tm) Pulmonary Function Testing System | K895414 | FDA 510(k) | Class II | Active |
| Ims-2000r Resting Electrocardiographic System | K870934 | FDA 510(k) | Class II | Active |
| Ims-2000s Stress Monitor | K871659 | FDA 510(k) | Class II | Active |
| Stick-Gard Sterile Cap | K902682 | FDA 510(k) | N/A | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (22)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
The FDA recall records for Integrated Medical Systems, Inc. consist of 22 records, all of which were initiated on 2016-01-20. The status of these recalls is recorded as terminated. The reasons given for the recalls include the potential for the internal coil pipe assembly at the distal end of the endoscope to become detached if excessive pressure is applied, which may cause angulation to not operate as intended.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 20, 2016 | Z-0894-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0895-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0900-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0902-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0897-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0889-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0896-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0899-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0907-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0891-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0904-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0910-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0901-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0898-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0909-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0893-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0908-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0906-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0903-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0890-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0905-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |
| Jan 20, 2016 | Z-0892-2016 | — | terminated | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. |