MIDAS REX MR8
Model EM800 · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000430917
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
HBC — Motor, Drill, Electric · Class II · 21 CFR 882.4360
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (186)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 183 · Injury: 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.63 |
| 2019-02 | 0 | 3.47 |
| 2019-03 | 0 | 6.65 |
| 2019-04 | 0 | 5.33 |
| 2019-05 | 0 | 3.84 |
| 2019-06 | 0 | 4.13 |
| 2019-07 | 0 | 3.97 |
| 2019-08 | 0 | 5.07 |
| 2019-09 | 0 | 4.04 |
| 2019-10 | 0 | 4.08 |
| 2019-11 | 0 | 4.92 |
| 2019-12 | 0 | 4.9 |
| 2020-01 | 0 | 4.4 |
| 2020-02 | 0 | 3.85 |
| 2020-03 | 0 | 4.71 |
| 2020-04 | 0 | 4.38 |
| 2020-05 | 0 | 2.91 |
| 2020-06 | 0 | 5.59 |
| 2020-07 | 0 | 5.3 |
| 2020-08 | 0 | 4.34 |
| 2020-09 | 0 | 4.43 |
| 2020-10 | 0 | 4.86 |
| 2020-11 | 0 | 4.61 |
| 2020-12 | 0 | 5.15 |
| 2021-01 | 0 | 4.43 |
| 2021-02 | 0 | 4.85 |
| 2021-03 | 0 | 5.58 |
| 2021-04 | 0 | 4.33 |
| 2021-05 | 0 | 4.46 |
| 2021-06 | 0 | 5.41 |
| 2021-07 | 0 | 4.46 |
| 2021-08 | 0 | 4.65 |
| 2021-09 | 0 | 3.79 |
| 2021-10 | 0 | 3.05 |
| 2021-11 | 0 | 4.11 |
| 2021-12 | 0 | 3.53 |
| 2022-01 | 0 | 3.42 |
| 2022-02 | 0 | 3.14 |
| 2022-03 | 0 | 3.33 |
| 2022-04 | 0 | 3.66 |
| 2022-05 | 0 | 2.9 |
| 2022-06 | 0 | 4.17 |
| 2022-07 | 0 | 3.85 |
| 2022-08 | 0 | 4.25 |
| 2022-09 | 0 | 3.68 |
| 2022-10 | 0 | 3.9 |
| 2022-11 | 0 | 4.43 |
| 2022-12 | 0 | 4.24 |
| 2023-01 | 0 | 3.46 |
| 2023-02 | 0 | 3.87 |
| 2023-03 | 0 | 4.25 |
| 2023-04 | 0 | 4.18 |
| 2023-05 | 0 | 4.89 |
| 2023-06 | 1 | 3.97 |
| 2023-07 | 0 | 4.53 |
| 2023-08 | 0 | 3.58 |
| 2023-09 | 1 | 3.89 |
| 2023-10 | 0 | 3.49 |
| 2023-11 | 0 | 3.68 |
| 2023-12 | 1 | 3.38 |
| 2024-01 | 1 | 4.02 |
| 2024-02 | 3 | 4.52 |
| 2024-03 | 0 | 4.16 |
| 2024-04 | 5 | 4.2 |
| 2024-05 | 1 | 3.15 |
| 2024-06 | 0 | 3.45 |
| 2024-07 | 1 | 3.53 |
| 2024-08 | 5 | 3.48 |
| 2024-09 | 19 | 5.09 |
| 2024-10 | 6 | 3.83 |
| 2024-11 | 8 | 3.54 |
| 2024-12 | 6 | 3.63 |
| 2025-01 | 8 | 3.21 |
| 2025-02 | 9 | 7.11 |
| 2025-03 | 28 | 6.45 |
| 2025-04 | 3 | 3.01 |
| 2025-05 | 9 | 4.04 |
| 2025-06 | 3 | 3.42 |
| 2025-07 | 18 | 4.07 |
| 2025-08 | 8 | 3.49 |
| 2025-09 | 10 | 3.15 |
| 2025-10 | 10 | 3.97 |
| 2025-11 | 10 | 3.17 |
| 2025-12 | 1 | 3.28 |
| 2026-01 | 0 | 2.62 |
| 2026-02 | 3 | 3.27 |
| 2026-03 | 5 | 3.63 |
| 2026-04 | 3 | 4.94 |
| 2026-05 | 0 | 3.86 |
| 2026-06 | 0 | 3.56 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K183515 — cites (transitively): K163182 (d1), K163565 (d1), K170312 (d1), K020069 (d2), K072315 (d2), K090112 (d2), K870157 (d2), K081475 (d2), K012457 (d2), K121264 (d2), K081277 (d3) — cited as predicate by K183644, K202552, K213454, K252662
K183644 — cites (transitively): K160713 (d1), K183515 (d1), K081475 (d2), K090112 (d2), K143628 (d2), K163182 (d2), K163565 (d2), K170312 (d2), K140454 (d3), K020069 (d3), K072315 (d3), K870157 (d3), K012457 (d3), K121264 (d3), K081277 (d4), K124004 (d4), K050438 (d5) — cited as predicate by K202552, K230064, K233638, K240568, K251316
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS
- NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations