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BiomarC®

Model 040402 · Carbon Medical Technologies, Inc. · DI 00858015005110

GDW — Staple, Implantable · Class II · 21 CFR 878.4750

NEU — Marker, Radiographic, Implantable · Class II · 21 CFR 878.4300

UDILibrary device dossier · generated 2026-09-13 · 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.

369122019-01: 0 reports for this device; peer average 8.71/device2019-02: 0 reports for this device; peer average 8.74/device2019-03: 0 reports for this device; peer average 9.31/device2019-04: 0 reports for this device; peer average 9.79/device2019-05: 0 reports for this device; peer average 8.35/device2019-06: 0 reports for this device; peer average 10.21/device2019-07: 0 reports for this device; peer average 10.14/device2019-08: 0 reports for this device; peer average 8.25/device2019-09: 0 reports for this device; peer average 8.56/device2019-10: 0 reports for this device; peer average 8.48/device2019-11: 0 reports for this device; peer average 8.75/device2019-12: 0 reports for this device; peer average 9.59/device2020-01: 0 reports for this device; peer average 9.18/device2020-02: 0 reports for this device; peer average 8.52/device2020-03: 0 reports for this device; peer average 8.87/device2020-04: 0 reports for this device; peer average 7.68/device2020-05: 0 reports for this device; peer average 7.11/device2020-06: 0 reports for this device; peer average 9.18/device2020-07: 0 reports for this device; peer average 9.73/device2020-08: 0 reports for this device; peer average 9.35/device2020-09: 0 reports for this device; peer average 10.38/device2020-10: 0 reports for this device; peer average 10.19/device2020-11: 0 reports for this device; peer average 9.81/device2020-12: 0 reports for this device; peer average 10.74/device2021-01: 0 reports for this device; peer average 9.12/device2021-02: 0 reports for this device; peer average 9.01/device2021-03: 0 reports for this device; peer average 8.94/device2021-04: 0 reports for this device; peer average 10.28/device2021-05: 0 reports for this device; peer average 9.51/device2021-06: 0 reports for this device; peer average 9.39/device2021-07: 0 reports for this device; peer average 9.37/device2021-08: 0 reports for this device; peer average 11.89/device2021-09: 0 reports for this device; peer average 10.57/device2021-10: 0 reports for this device; peer average 9.84/device2021-11: 0 reports for this device; peer average 8.52/device2021-12: 0 reports for this device; peer average 10.49/device2022-01: 0 reports for this device; peer average 8.98/device2022-02: 0 reports for this device; peer average 8.54/device2022-03: 0 reports for this device; peer average 9.32/device2022-04: 0 reports for this device; peer average 9.01/device2022-05: 0 reports for this device; peer average 8.73/device2022-06: 0 reports for this device; peer average 10.25/device2022-07: 0 reports for this device; peer average 9.4/device2022-08: 0 reports for this device; peer average 10.16/device2022-09: 0 reports for this device; peer average 9.18/device2022-10: 0 reports for this device; peer average 9.71/device2022-11: 0 reports for this device; peer average 9.88/device2022-12: 0 reports for this device; peer average 10.2/device2023-01: 0 reports for this device; peer average 9.16/device2023-02: 0 reports for this device; peer average 9.22/device2023-03: 0 reports for this device; peer average 11.89/device2023-04: 0 reports for this device; peer average 9.3/device2023-05: 0 reports for this device; peer average 9.38/device2023-06: 0 reports for this device; peer average 10.71/device2023-07: 0 reports for this device; peer average 10.49/device2023-08: 0 reports for this device; peer average 8.07/device2023-09: 0 reports for this device; peer average 7.96/device2023-10: 0 reports for this device; peer average 8.23/device2023-11: 0 reports for this device; peer average 7.8/device2023-12: 0 reports for this device; peer average 8.98/device2024-01: 0 reports for this device; peer average 9.37/device2024-02: 0 reports for this device; peer average 9.62/device2024-03: 0 reports for this device; peer average 7.38/device2024-04: 0 reports for this device; peer average 8.28/device2024-05: 0 reports for this device; peer average 7.08/device2024-06: 0 reports for this device; peer average 7.98/device2024-07: 0 reports for this device; peer average 8.14/device2024-08: 0 reports for this device; peer average 7.55/device2024-09: 0 reports for this device; peer average 9.32/device2024-10: 0 reports for this device; peer average 8.41/device2024-11: 0 reports for this device; peer average 9.03/device2024-12: 0 reports for this device; peer average 7.06/device2025-01: 0 reports for this device; peer average 8.28/device2025-02: 0 reports for this device; peer average 7.04/device2025-03: 0 reports for this device; peer average 8.89/device2025-04: 0 reports for this device; peer average 7.15/device2025-05: 0 reports for this device; peer average 8.37/device2025-06: 0 reports for this device; peer average 7.97/device2025-07: 0 reports for this device; peer average 10.31/device2025-08: 0 reports for this device; peer average 8.65/device2025-09: 0 reports for this device; peer average 8.45/device2025-10: 0 reports for this device; peer average 7.53/device2025-11: 0 reports for this device; peer average 8.64/device2025-12: 0 reports for this device; peer average 9.7/device2026-01: 0 reports for this device; peer average 8.91/device2026-02: 0 reports for this device; peer average 8.75/device2026-03: 0 reports for this device; peer average 9.27/device2026-04: 0 reports for this device; peer average 8.66/device2026-05: 0 reports for this device; peer average 8.25/device2026-06: 0 reports for this device; peer average 9.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0108.71
2019-0208.74
2019-0309.31
2019-0409.79
2019-0508.35
2019-06010.21
2019-07010.14
2019-0808.25
2019-0908.56
2019-1008.48
2019-1108.75
2019-1209.59
2020-0109.18
2020-0208.52
2020-0308.87
2020-0407.68
2020-0507.11
2020-0609.18
2020-0709.73
2020-0809.35
2020-09010.38
2020-10010.19
2020-1109.81
2020-12010.74
2021-0109.12
2021-0209.01
2021-0308.94
2021-04010.28
2021-0509.51
2021-0609.39
2021-0709.37
2021-08011.89
2021-09010.57
2021-1009.84
2021-1108.52
2021-12010.49
2022-0108.98
2022-0208.54
2022-0309.32
2022-0409.01
2022-0508.73
2022-06010.25
2022-0709.4
2022-08010.16
2022-0909.18
2022-1009.71
2022-1109.88
2022-12010.2
2023-0109.16
2023-0209.22
2023-03011.89
2023-0409.3
2023-0509.38
2023-06010.71
2023-07010.49
2023-0808.07
2023-0907.96
2023-1008.23
2023-1107.8
2023-1208.98
2024-0109.37
2024-0209.62
2024-0307.38
2024-0408.28
2024-0507.08
2024-0607.98
2024-0708.14
2024-0807.55
2024-0909.32
2024-1008.41
2024-1109.03
2024-1207.06
2025-0108.28
2025-0207.04
2025-0308.89
2025-0407.15
2025-0508.37
2025-0607.97
2025-07010.31
2025-0808.65
2025-0908.45
2025-1007.53
2025-1108.64
2025-1209.7
2026-0108.91
2026-0208.75
2026-0309.27
2026-0408.66
2026-0508.25
2026-0609.65
This device (reports/month)Average device in GDW, NEU (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Carbon Medical Technologies, Inc.

  • NAI 2023-11-02 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2023-11-02 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2019-12-16 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2019-12-16 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2016-03-09 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2016-03-09 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2011-05-10 Carbon Medical Technologies, Inc. · 0 citations
  • NAI 2011-05-10 Carbon Medical Technologies, Inc. · 0 citations