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BVital GENOSS Granules

Model BS-G010 · COLLAGEN MATRIX, INC. · DI 00813954024028

NPM — Bone Grafting Material, Animal Source · Class II · 21 CFR 872.3930

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.

13452019-03: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 5/device2023-11: 0 reports for this device; peer average 5/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 4/device2025-10: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device03050910100203040610031104060709110304070809101203
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0502
2019-0901
2019-1002
2020-1001
2021-0203
2022-0302
2022-0402
2022-0602
2022-1001.5
2023-0305
2023-1105
2024-0402
2024-0601
2024-0701
2024-0902
2024-1101
2025-0302
2025-0402
2025-0702
2025-0804
2025-0904
2025-1002
2025-1201
2026-0302
This device (reports/month)Average device in NPM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — COLLAGEN MATRIX, INC.

  • Warning Letter 2016-09-20 Collagen Matrix, Inc.
  • Warning Letter 2016-09-20 Collagen Matrix, Inc.
  • Warning Letter 2015-01-08 Collagen Matrix, Inc.
  • Warning Letter 2015-01-08 Collagen Matrix, Inc.
  • VAI 2017-07-18 Collagen Matrix Inc · 3 citations
  • VAI 2017-07-18 Collagen Matrix Inc · 3 citations
  • NAI 2017-07-13 Collagen Matrix, Inc. · 0 citations
  • NAI 2017-07-13 Collagen Matrix, Inc. · 0 citations
  • OAI 2015-11-25 Collagen Matrix, Inc. · 2 citations
  • OAI 2015-11-25 Collagen Matrix, Inc. · 2 citations
  • VAI 2011-12-05 Collagen Matrix, Inc. · 3 citations
  • VAI 2011-12-05 Collagen Matrix Inc · 3 citations
  • VAI 2011-12-05 Collagen Matrix, Inc. · 3 citations
  • VAI 2011-12-05 Collagen Matrix Inc · 3 citations