Quality Electrodynamics LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000001417
Quality Electrodynamics LLC is a medical device manufacturer based in the United States, with 93 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) and 9 FDA recalls as of 12 Nov 2026.
- Devices
- 93
- Registrations
- EUDAMED
- FDA recalls
- 9
Registry facts
- Registries
- FDA GUDID 58
- EUDAMED 50
- FDA 510(k) 25
- Device classes
- FDA Class II 55
- EU Class IIa 37
- FDA Class I 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000001417
- DUNS 614760119
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What Quality Electrodynamics LLC makes
Quality Electrodynamics LLC manufactures specialized MRI system coils, including radio-frequency coils for the head, neck, knee, and wrist, such as the 32-channel Head SPEEDER Coil and 16-channel Tx/Rx Knee SPEEDER Coil. The company also produces magnetic resonance elastography acoustic drivers and non-wearable radiological breast positioners, like the Breast Riser CX. Additionally, it supplies radiation therapy simulation systems, including the HEAD NECK SIMULATOR and MEDIUM TORSO SIMULATOR.
The company’s products are regulated under FDA 510(k) and UDI requirements in the US, with some devices classified as Class I and others as Class II or Class IIa. These devices are listed in the EU’s EUDAMED registry, ensuring traceability and compliance with relevant medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 93 devicesShowing 1-50 of 93
Company details
- EUDAMED SRN
- US-MF-000001417
- DUNS number
- 614760119
- EUDAMED status
- Active
- EUDAMED registered name
- Quality Electrodynamics, LLC
- EUDAMED abbreviated name
- QED
- Registered address
- 6655, Beta Drive, 44143, Mayfield Village, United States
- Website
- www.qualityelectrodynamics.com
- PRRC contact
- Craig Woodworth
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 24 Feb 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 721671 Active
Quality assurance EU MDR
- Issued
- 7 Aug 2026
- Expires
- 24 Feb 2031
- Reason
- Add device or group
FDA recalls
FDA recall records list 9 recalls initiated by QUALITY ELECTRODYNAMICS LLC, the earliest on 2008-12-29 and the most recent on 2019-08-20. By recorded status: 9 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 7
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 20 Aug 2019 Z-0031-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- 20 Aug 2019 Z-0032-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- 20 Aug 2019 Z-0033-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- 20 Aug 2019 Z-0034-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- 20 Aug 2019 Z-0035-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- 20 Aug 2019 Z-0036-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
- 20 Aug 2019 Z-0037-2020 Class II Terminated Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
2012
- 27 Jul 2012 Z-2314-2012 Class II Terminated On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.
2008
- 29 Dec 2008 Z-1938-2009 Unclassified (pre-2012) Terminated The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
Frequently asked questions
How many devices does QUALITY ELECTRODYNAMICS LLC have in the registry?
The registry currently lists 93 devices for QUALITY ELECTRODYNAMICS LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list QUALITY ELECTRODYNAMICS LLC's devices?
Among its 50 most recently registered devices, QUALITY ELECTRODYNAMICS LLC has devices listed in EUDAMED (16 devices), FDA 510(k) (16 devices) and FDA GUDID (32 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do QUALITY ELECTRODYNAMICS LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for QUALITY ELECTRODYNAMICS LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for QUALITY ELECTRODYNAMICS LLC?
FDA recall records list 9 recalls initiated by QUALITY ELECTRODYNAMICS LLC, the most recent initiated on 20 Aug 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for QUALITY ELECTRODYNAMICS LLC?
EUDAMED lists 1 certificate for QUALITY ELECTRODYNAMICS LLC (quality assurance) under MDR. The most recent was issued on 7 Aug 2026.
What are the newest devices from QUALITY ELECTRODYNAMICS LLC in the registry?
The most recently registered devices listed for QUALITY ELECTRODYNAMICS LLC include 32ch Head SPEEDER Coil Q7000032, HEAD NECK SIMULATOR 2001000, Atlas SPEEDER Head-Neck Coil Q7000021 and MEDIUM TORSO SIMULATOR 2001001.