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Medical Device Data System
FDA product code OUG · Class 1 · General Hospital
914
Registered devices
2,980
Adverse events
24
Recalls
1
510(k) clearances
Devices with this code
DreamStation — Respironics, Inc.BioSerenity-Link — BIOSERENITY MEDICAL DEVICES GROUPResponder — RAULAND-BORG CORPORATIONIntesys® Clinical Suite — SPACELABS HEALTHCARE (WASHINGTON), INCCorPath Imaging System — Corindus, Inc.ENDOPRO IQ — PENTAX OF AMERICA, INC.ENDOPRO IQ — PENTAX OF AMERICA, INC.CareStation Server — Kestra Medical Technologies, Inc.N/A — PENTAX OF AMERICA, INC.Broadband — Respironics, Inc.Trilogy O2 — Respironics, Inc.Trilogy 200 — Respironics, Inc.N/A — MEDTRONIC, INC.FreeStyle — ABBOTT DIABETES CARE LTDDreamStation — Respironics, Inc.Responder — RAULAND-BORG CORPORATIONASSURE Patient Application — Kestra Medical Technologies, Inc.Trilogy 200 — Respironics, Inc.Responder — RAULAND-BORG CORPORATIONN/A — PENTAX OF AMERICA, INC.Responder — RAULAND-BORG CORPORATIONResponder — RAULAND-BORG CORPORATIONNeuronaute Application Mobile iOS — BIOSERENITY MEDICAL DEVICES GROUPOmniSight™ — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-08 | Radiometer Medical ApS | Due to potential software issue that may result in patient mix-up information. |
| 2023-02-06 | Biomerieux Inc | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always be |
| 2021-09-02 | BioMerieux SA | Under certain conditions, there is a risk for a false negative result. |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Pa |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Pa |
| 2020-01-17 | Beckman Coulter Inc. | A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some cus |
| 2019-09-25 | ENDOTRONIX | The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. |
| 2019-08-08 | Radiometer Medical ApS | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when co |
| 2019-05-20 | Opternative Inc | Lack of 510K clearance |
| 2017-12-06 | Intel-GE Care Innovations LLC | It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely |
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