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Model D-208-700/FC100 · TARRY MEDICAL PRODUCTS, INC. · DI 00854758006209

FMT — Warmer, Infant Radiant · Class II · 21 CFR 880.5130

FMZ — Incubator, Neonatal · Class II · 21 CFR 880.5400

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.

4811152019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.25/device2019-08: 0 reports for this device; peer average 1.6/device2019-09: 0 reports for this device; peer average 1.6/device2019-10: 0 reports for this device; peer average 2.67/device2020-01: 0 reports for this device; peer average 5/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 1.33/device2020-04: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1.5/device2020-09: 0 reports for this device; peer average 3.5/device2020-10: 0 reports for this device; peer average 1.8/device2020-11: 0 reports for this device; peer average 7/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 1.67/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1.75/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 4.5/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 2.33/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 3.67/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 3.67/device2022-06: 0 reports for this device; peer average 1.29/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 1.25/device2022-09: 0 reports for this device; peer average 1.75/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 4/device2022-12: 0 reports for this device; peer average 3.8/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 5/device2023-03: 0 reports for this device; peer average 1.67/device2023-04: 0 reports for this device; peer average 8/device2023-05: 0 reports for this device; peer average 7.5/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 5/device2023-08: 0 reports for this device; peer average 5/device2023-09: 0 reports for this device; peer average 14.5/device2023-10: 0 reports for this device; peer average 7.8/device2023-11: 0 reports for this device; peer average 5.63/device2023-12: 0 reports for this device; peer average 9.25/device2024-01: 0 reports for this device; peer average 2.67/device2024-02: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 4.5/device2024-04: 0 reports for this device; peer average 1.8/device2024-05: 0 reports for this device; peer average 2.33/device2024-06: 0 reports for this device; peer average 1.43/device2024-07: 0 reports for this device; peer average 3.67/device2024-08: 0 reports for this device; peer average 5.38/device2024-09: 0 reports for this device; peer average 7.17/device2024-10: 0 reports for this device; peer average 3.33/device2024-11: 0 reports for this device; peer average 13.25/device2024-12: 0 reports for this device; peer average 13.14/device2025-01: 0 reports for this device; peer average 8.29/device2025-02: 0 reports for this device; peer average 13.17/device2025-03: 0 reports for this device; peer average 14/device2025-04: 0 reports for this device; peer average 13.43/device2025-05: 0 reports for this device; peer average 11.13/device2025-06: 0 reports for this device; peer average 14.14/device2025-07: 0 reports for this device; peer average 10.2/device2025-08: 0 reports for this device; peer average 15.29/device2025-09: 0 reports for this device; peer average 8.5/device2025-10: 0 reports for this device; peer average 7.22/device2025-11: 0 reports for this device; peer average 8.83/device2025-12: 0 reports for this device; peer average 7.5/device2026-01: 0 reports for this device; peer average 4.73/device2026-02: 0 reports for this device; peer average 5.9/device2026-03: 0 reports for this device; peer average 12.86/device2026-04: 0 reports for this device; peer average 8.1/device2026-05: 0 reports for this device; peer average 10.67/device2026-06: 0 reports for this device; peer average 6.29/device010203040506070809100102030406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0301
2019-0401.5
2019-0502
2019-0601.5
2019-0701.25
2019-0801.6
2019-0901.6
2019-1002.67
2020-0105
2020-0201.33
2020-0301.33
2020-0403
2020-0601
2020-0701
2020-0801.5
2020-0903.5
2020-1001.8
2020-1107
2020-1201
2021-0102
2021-0205
2021-0302.5
2021-0402
2021-0502.5
2021-0601.67
2021-0701
2021-0801.75
2021-0902
2021-1004.5
2021-1101.5
2021-1202.33
2022-0101
2022-0201
2022-0303.67
2022-0401.75
2022-0503.67
2022-0601.29
2022-0701.5
2022-0801.25
2022-0901.75
2022-1001
2022-1104
2022-1203.8
2023-0101
2023-0205
2023-0301.67
2023-0408
2023-0507.5
2023-0603
2023-0705
2023-0805
2023-09014.5
2023-1007.8
2023-1105.63
2023-1209.25
2024-0102.67
2024-0202.5
2024-0304.5
2024-0401.8
2024-0502.33
2024-0601.43
2024-0703.67
2024-0805.38
2024-0907.17
2024-1003.33
2024-11013.25
2024-12013.14
2025-0108.29
2025-02013.17
2025-03014
2025-04013.43
2025-05011.13
2025-06014.14
2025-07010.2
2025-08015.29
2025-0908.5
2025-1007.22
2025-1108.83
2025-1207.5
2026-0104.73
2026-0205.9
2026-03012.86
2026-0408.1
2026-05010.67
2026-0606.29
This device (reports/month)Average device in FMT, FMZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — TARRY MEDICAL PRODUCTS, INC.

  • VAI 2026-03-03 Tarry Medical Products, Inc. · 1 citations
  • VAI 2026-03-03 Tarry Medical Products, Inc. · 1 citations
  • NAI 2023-09-27 Tarry Medical Products, Inc. · 0 citations
  • NAI 2023-09-27 Tarry Medical Products, Inc. · 0 citations
  • VAI 2015-10-15 Tarry Medical Products, Inc. · 5 citations
  • VAI 2015-10-15 Tarry Medical Products, Inc. · 5 citations