Print-ready dossier — use your browser's print dialog to save as PDF.
AVAflex
Model AFB1020 · CAREFUSION 2200, INC · DI 10885403223242
HRX — Arthroscope · Class II · 21 CFR 888.1100
NDN — Cement, Bone, Vertebroplasty · Class II · 21 CFR 888.3027
UDILibrary device dossier · generated 2026-09-11 · 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
12.67
2019-02
0
3.22
2019-03
0
3.71
2019-04
0
3.94
2019-05
0
3.91
2019-06
0
3.56
2019-07
0
3.23
2019-08
0
3.71
2019-09
0
4.42
2019-10
0
4.64
2019-11
0
4.45
2019-12
0
4.93
2020-01
0
4.95
2020-02
0
5.19
2020-03
0
5.07
2020-04
0
4.82
2020-05
0
3.44
2020-06
0
5.37
2020-07
0
5.23
2020-08
0
5.18
2020-09
0
7.19
2020-10
0
8.47
2020-11
0
5.37
2020-12
0
8.81
2021-01
0
6.12
2021-02
0
5.67
2021-03
0
7.49
2021-04
0
5.95
2021-05
0
5.47
2021-06
0
5.28
2021-07
0
4.33
2021-08
0
5.11
2021-09
0
3.24
2021-10
0
4.68
2021-11
0
3.66
2021-12
0
5.04
2022-01
0
4.68
2022-02
0
3.48
2022-03
0
4.15
2022-04
0
3.87
2022-05
0
3.96
2022-06
0
4.28
2022-07
0
3.98
2022-08
0
3.74
2022-09
0
3.82
2022-10
0
3.89
2022-11
0
4.37
2022-12
0
4.34
2023-01
0
4.72
2023-02
0
4.27
2023-03
0
5.14
2023-04
0
4.44
2023-05
0
4.5
2023-06
0
4.25
2023-07
0
4.17
2023-08
0
4.59
2023-09
0
4.76
2023-10
0
4.23
2023-11
0
7.15
2023-12
0
8.7
2024-01
0
5.74
2024-02
0
6.4
2024-03
0
5.03
2024-04
0
5.59
2024-05
0
8.45
2024-06
0
8.3
2024-07
0
4.65
2024-08
0
4.72
2024-09
0
4.38
2024-10
0
5.78
2024-11
0
4.77
2024-12
0
6.59
2025-01
0
7.81
2025-02
0
5.72
2025-03
0
4.69
2025-04
0
4.92
2025-05
0
5.22
2025-06
0
4.55
2025-07
0
4.39
2025-08
0
4
2025-09
0
4.34
2025-10
0
4.61
2025-11
0
5.51
2025-12
0
5.51
2026-01
0
4.98
2026-02
0
5.41
2026-03
0
4.81
2026-04
0
6.45
2026-05
0
4.15
2026-06
0
4.35
This device (reports/month)Average device in HRX, NDN (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — CAREFUSION 2200, INC