Quality Electrodynamics, LLC
Quality Electrodynamics, LLC holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2025, with 8 FDA device recalls on record.
Top product codes for Quality Electrodynamics, LLC
FDA recalls by Quality Electrodynamics, LLC
- Z-0033-2020 — TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
- Z-0035-2020 — TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
- Z-0034-2020 — TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
- Z-0032-2020 — TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
- Z-0037-2020 — TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
- Z-0031-2020 — TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
- Z-0036-2020 — TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
- Z-2314-2012 — TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Quality Electrodynamics, LLC
- K242006 — SureWave Elastography (Q7000225)
- K223429 — Contour Knee
- K200477 — Flex Body Speeder
- K193140 — Flex Body SPEEDER
- K183111 — Contour 24
- K181697 — 16ch Foot/ Ankle SPEEDER
- K173469 — 16ch T/R Hand Wrist Coil
- K173446 — Contour 24
- K162946 — 8ch Knee-Foot SPEEDER
- K162623 — 16ch T/R Hand Wrist Coil
- K162966 — TxRx Knee 15 Flare MR Coil 1.5T
- K163066 — TxRx Knee 15 Flare MR Coil 3.0T
- K162029 — 16ch T/R Knee Coil
- K161193 — 16ch Tx/Rx Knee SPEEDER
- K152695 — 8 CH Knee SPEEDER
- K151753 — 16 ch Tx/Rx Knee SPEEDER
- K151829 — Atlas SPEEDER Header/Neck
- K150331 — 18ch T/R Knee Coil
- K142802 — Atlas SPEEDER Head/Neck
- K142002 — BREAST SPEEDER CX, GRID HOLDER CX
- K140998 — PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.