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Sign in to claim this brandMORTARA INSTRUMENT, INC.
US
Last updated May 24, 2026
What MORTARA INSTRUMENT, INC. makes
Mortara Instrument, Inc. manufactures professional multichannel electrocardiographs, reusable electrocardiographic lead sets, and cardiac stress exercise monitoring systems. Their portfolio also includes long-term ambulatory ECG recording analyser software, multi-patient physiologic monitoring systems for intensive and general healthcare, and cardiology information system applications. Additional offerings include ambulatory ECG recorders and patient health record information systems, along with associated cardiopulmonary monitoring kits and lead sets.
All listed devices fall under Class II regulatory classification in the U.S. and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mortara.com
- —
- —
- [email protected]
- Phone
- 888-667-8272
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 062046149
Catalogue (818)
Page 17 of 17| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surveyor S4 Mobile Monitor | K141020 | FDA 510(k) | Class II | Active |
| H12+ Holter Recorder | K050896 | FDA 510(k) | Class II | Active |
| CardioConfirm | K161465 | FDA 510(k)FDA UDI | Class II | Active |
| Mortara Instrument Odel Eli 50i | K915730 | FDA 510(k) | N/A | Active |
| Pr4 | K911097 | FDA 510(k) | Class II | Active |
| Siemens-Elema (sicard-P) | K861851 | FDA 510(k) | Class II | Active |
| Mortara Instrument Model Eli 50 | K902652 | FDA 510(k) | Class II | Active |
| Mortara Instrument Model El-1 | K851702 | FDA 510(k) | Class II | Active |
| Ambulatory X-12 Telemetry Module | K974149 | FDA 510(k) | Class II | Active |
| Ambulo 2400 Ambulatory Blood Pressure Monitoring System | K133989 | FDA 510(k) | Class II | Active |
| Eli 250 Electrocardiograph | K101403 | FDA 510(k) | Class II | Active |
| Ecg Review Station | K942685 | FDA 510(k) | Class II | Active |
| Rscribe Electrocardiograph | K120865 | FDA 510(k) | Class II | Active |
| Surveyor Patient Monitor | K173765 | FDA 510(k) | Class II | Active |
| Eli 150 Electrocardiograph Model Eli 150 | K101115 | FDA 510(k) | Class II | Active |
| H12+holter Recorder | K021373 | FDA 510(k) | Class II | Active |
| Eli 380 Electrocardiograph | K142105 | FDA 510(k) | Class II | Active |
| Eli 350 Electrocardiograph | K092663 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Mortara Instrument, Inc. has two recall records initiated between October 7, 2014, and May 29, 2015, both of which are marked as terminated. The first involved the ELI 380 electrocardiograph, where a potential issue was identified regarding incorrect patient demographic associations during waveform transmission in a specific workflow. The second concerned the Surveyor and S12/S19 Patient Monitors, citing a potential safety hazard related to improper mounting using the provided 75mm VESA hole pattern in the battery cover.
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 |
|---|---|---|---|---|
| May 29, 2015 | Z-1796-2015 | — | terminated | Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system. |
| Oct 7, 2014 | Z-0110-2015 | — | terminated | Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p |