Mortara Instrument, Inc.
United StatesFDA applicant, unverified
Mortara Instrument, Inc. is a medical device manufacturer, with 818 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II) and 2 FDA recalls as of 12 Nov 2026.
- Devices
- 818
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 768
- EUDAMED 116
- FDA 510(k) 51
- Device classes
- FDA Class II 812
- FDA recalls
- Identifiers
- DUNS 062046149
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 818 devicesShowing 1-50 of 818
Company details
- DUNS number
- 062046149
- Phone
- 888-667-8272
FDA recalls
FDA recall records list 2 recalls initiated by MORTARA INSTRUMENT, INC., the earliest on 2014-10-07 and the most recent on 2015-05-29. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 29 May 2015 Z-1796-2015 Class II 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.
Full distribution text
- 29 May 2015 Z-1796-2015 Class II 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.
2014
- 7 Oct 2014 Z-0110-2015 Class II 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
Full distribution text
- 7 Oct 2014 Z-0110-2015 Class II 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
Frequently asked questions
How many devices does MORTARA INSTRUMENT, INC. have in the registry?
The registry currently lists 818 devices for MORTARA INSTRUMENT, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MORTARA INSTRUMENT, INC.'s devices?
Among its 50 most recently registered devices, MORTARA INSTRUMENT, INC. has devices listed in EUDAMED (3 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MORTARA INSTRUMENT, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for MORTARA INSTRUMENT, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for MORTARA INSTRUMENT, INC.?
FDA recall records list 2 recalls initiated by MORTARA INSTRUMENT, INC., the most recent initiated on 29 May 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from MORTARA INSTRUMENT, INC. in the registry?
The most recently registered devices listed for MORTARA INSTRUMENT, INC. include ELI 150c ELI150c-CAC-AEABX, SunTech Tango M2 Kit 9922-020-50, Surveyor S19 SUR19-NAA-XXAAX and ELI 280 BUR280-C1X.