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MIDAS REX MICROSAWS
Model 200S70-04F · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000464011
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
UDILibrary device dossier · generated 2026-09-07 · 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 (0)
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.34
2019-02
0
3.6
2019-03
0
5.97
2019-04
0
4.57
2019-05
0
3.94
2019-06
0
4
2019-07
0
3.76
2019-08
0
4.9
2019-09
0
3.83
2019-10
0
3.71
2019-11
0
4.67
2019-12
0
4.64
2020-01
0
3.83
2020-02
0
4.54
2020-03
0
4.85
2020-04
0
3.92
2020-05
0
2.96
2020-06
0
5.26
2020-07
0
4.67
2020-08
0
4.06
2020-09
0
4.47
2020-10
0
4.6
2020-11
0
4.72
2020-12
0
4.89
2021-01
0
4.21
2021-02
0
4.41
2021-03
0
5.01
2021-04
0
3.83
2021-05
0
3.99
2021-06
0
4.87
2021-07
0
3.99
2021-08
0
4.88
2021-09
0
3.81
2021-10
0
3.04
2021-11
0
3.93
2021-12
0
3.82
2022-01
0
3.19
2022-02
0
3.29
2022-03
0
3.54
2022-04
0
3.15
2022-05
0
3.1
2022-06
0
4.06
2022-07
0
3.64
2022-08
0
4.14
2022-09
0
3.81
2022-10
0
3.79
2022-11
0
4.07
2022-12
0
4.35
2023-01
0
3.33
2023-02
0
3.91
2023-03
0
4.41
2023-04
0
3.65
2023-05
0
4.93
2023-06
0
4
2023-07
0
3.65
2023-08
0
3.67
2023-09
0
3.78
2023-10
0
3.13
2023-11
0
3.94
2023-12
0
3.18
2024-01
0
3.62
2024-02
0
4.14
2024-03
0
4.09
2024-04
0
3.51
2024-05
0
3.11
2024-06
0
3.4
2024-07
0
3.07
2024-08
0
3.23
2024-09
0
4.19
2024-10
0
3.31
2024-11
0
3.03
2024-12
0
3.42
2025-01
0
2.74
2025-02
0
5.67
2025-03
0
3.6
2025-04
0
2.32
2025-05
0
3.45
2025-06
0
3.14
2025-07
0
3.12
2025-08
0
2.8
2025-09
0
2.62
2025-10
0
3.19
2025-11
0
3.2
2025-12
0
3.24
2026-01
0
2.26
2026-02
0
2.98
2026-03
0
4.02
2026-04
0
4.65
2026-05
0
4.51
2026-06
0
12.17
This device (reports/month)Average device in ERL, HBE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K081475 — cited as predicate by K111520, K121264, K130755, K132264, K133061, K141122, K143399, K160713, K163565, K170312, K193630, K233958, K240568
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