Integrated Medical Systems Inc
Bolingbrook, IL, US
INTEGRATED MEDICAL SYSTEMS, INC. appears in FDA device records in Bolingbrook, IL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 22 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Integrated Medical Systems Inc between 1987 and 2008. The busiest year on record is 1987, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1990 | 2 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082256 | LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE | MWI | Substantially Equivalent | |
| K902682 | STICK-GARD STERILE CAP | LDQ | Substantially Equivalent | |
| K895414 | MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM | BZG | Substantially Equivalent | |
| K871659 | IMS-2000S STRESS MONITOR | DXG | Substantially Equivalent | |
| K870934 | IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM | DXG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3018574830 | 3018574830 | INTEGRATED MEDICAL SYSTEMS, INC. | 594 Territorial Drive, Bolingbrook, IL 60440 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0910-2016 | Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0909-2016 | Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0908-2016 | Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope | 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. | Class II | Terminated | |
| Z-0907-2016 | Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0906-2016 | Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0905-2016 | Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope | 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. | Class II | Terminated | |
| Z-0904-2016 | Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0903-2016 | Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0902-2016 | Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0901-2016 | Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0900-2016 | Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0899-2016 | Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0898-2016 | Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0897-2016 | Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0896-2016 | Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0895-2016 | Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0894-2016 | Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0893-2016 | Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0892-2016 | Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0891-2016 | Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope | 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. | Class II | Terminated | |
| Z-0890-2016 | Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope | 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. | Class II | Terminated | |
| Z-0889-2016 | Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain