Engineered Medical Systems, LLC
United Statesfrom the FDA registration address FDA establishment FEI 3009973336
Engineered Medical Systems, LLC is a medical device manufacturer, with 123 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 123
- Registrations
- FDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 99
- FDA 510(k) 24
- Device classes
- FDA Class II 94
- FDA Class I 29
- FDA recalls
- Identifiers
- FDA FEI 3009973336
What Engineered Medical Systems, LLC makes
Engineered Medical Systems, LLC manufactures single-use and reusable respiratory support devices, including manual pulmonary resuscitators, anaesthesia breathing circuits, and cricothyrotomy kits. Their portfolio also includes heat/moisture exchangers, CPAP/BPAP nasal masks, atomizers, and in-line CPAP sets, as well as microbial filters for medical gas. Examples include the O2-MAX oxygen delivery system, the DART-Reach cricothyrotomy kit, and the ABC breathing circuit systems.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Catalogue
Search and filter all 123 devicesShowing 1-50 of 123
Company details
- FDA FEI number
- 3009973336
- Address
- 3325 Appling Rd, Bartlett, TN, 38133
FDA recalls
FDA recall records list 1 recall initiated by Engineered Medical Systems, LLC, initiated on 2011-09-12. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 12 Sep 2011 Z-1058-2013 Class I Terminated The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Frequently asked questions
How many devices does Engineered Medical Systems, LLC have in the registry?
The registry currently lists 123 devices for Engineered Medical Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Engineered Medical Systems, LLC's devices?
Among its 50 most recently registered devices, Engineered Medical Systems, LLC has devices listed in FDA GUDID (50 devices).
What risk classes do Engineered Medical Systems, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Engineered Medical Systems, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Engineered Medical Systems, LLC?
FDA recall records list 1 recall initiated by Engineered Medical Systems, LLC, the most recent initiated on 12 Sep 2011. 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 Engineered Medical Systems, LLC in the registry?
The most recently registered devices listed for Engineered Medical Systems, LLC include Bacterial/Viral Filter 301-435, O2-MAX 313-8007X, DART-Reach 301-REACH720 and ABC - Compact Breathing Circuit C072323M1X1A4.