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C-CURVE

Model A20500650 · MEDICREA INTERNATIONAL · DI 03613720283225

HWJ — Awl · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-12 · 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.

23562019-02: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 6/device2021-02: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.67/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 2.14/device2025-03: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1.25/device2025-12: 0 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1.33/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1.5/device0205091011030506091202050708091005070810120103040610111203040607081011120103070912010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0501
2019-0901
2019-1002
2019-1101
2020-0301
2020-0502
2020-0601
2020-0901
2020-1206
2021-0202
2021-0501.5
2021-0702
2021-0801
2021-0901
2021-1001
2022-0501
2022-0701.5
2022-0802
2022-1002
2022-1201
2023-0101
2023-0303
2023-0402
2023-0602
2023-1002
2023-1101
2023-1201
2024-0301
2024-0401
2024-0601.67
2024-0701.67
2024-0801
2024-1001
2024-1101
2024-1201.67
2025-0102.14
2025-0301.5
2025-0701
2025-0901.25
2025-1201.5
2026-0101
2026-0201
2026-0301
2026-0401.33
2026-0501.5
2026-0601.5
This device (reports/month)Average device in HWJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K210470 — cites (transitively): K073285 (d1), K132894 (d1), K153373 (d1), K192018 (d1), K192570 (d1), K073351 (d2), K103033 (d2), K111119 (d2), K112388 (d2), K120345 (d2), K094042 (d2), K100967 (d2), K111264 (d2), K130177 (d2), K132584 (d2), K141953 (d2), K153122 (d2), K170399 (d2), K173535 (d2), K183557 (d2), K190959 (d2), K100214 (d3), K070754 (d3), P000028 (d3), P980048 (d3), K081917 (d3), K093093 (d3), K083389 (d3), K042571 (d3), K050624 (d3), K061836 (d3), K062132 (d3), K082014 (d3), P960025 (d3), K132594 (d3), K032812 (d3), K080615 (d3), K083714 (d3), K100889 (d3), K102067 (d3), K111626 (d3), K140055 (d3), K142940 (d3), K151596 (d3), K150481 (d3), K160125 (d3), P950019 (d3), K142589 (d3), K148529 (d3), K163269 (d3), K170676 (d3), K171686 (d3), K172676 (d3), K180364 (d3), K171689 (d3), K091088 (d4), K092336 (d4), K082801 (d4), P950002 (d4), K073109 (d4), K083447 (d4), K072415 (d4), K113252 (d4), K113559 (d4), K120819 (d4), K133494 (d4), K082698 (d4), K100945 (d4), K110843 (d4), K112316 (d4), K113138 (d4), K113561 (d4), K130699 (d4), K133614 (d4), K141405 (d4), K072991 (d4), K103169 (d4), K150362 (d4), K152304 (d4), K123045 (d4), K072253 (d4), K072791 (d4), K160547 (d4), K120570 (d4), K153107 (d4), K162103 (d4), K073291 (d4), K094025 (d4), K121332 (d4), K121333 (d4), K122037 (d4), K123027 (d4), K133205 (d4), K151128 (d4), K162358 (d4), K081611 (d4), K120603 (d4), K140003 (d4), K162138 (d4), K163230 (d4), K163491 (d4), K120275 (d4), K162264 (d4), K171496 (d4), K052261 (d5), K080401 (d5), K101302 (d5), K051454 (d5), K063399 (d5), K080024 (d5), K080699 (d5), K083626 (d5), K083894 (d5), K073202 (d5), K050553 (d5), K072465 (d5), K091426 (d5), K111123 (d5), K071833 (d5), K030327 (d5), K083026 (d5), K091813 (d5), K082732 (d5), K071795 (d5), K031672 (d5), K092211 (d5), K120031 (d5), K122630 (d5), K123206 (d5), K071724 (d5), K081968 (d5), K100089 (d5), K131372 (d5), K140921 (d5), K142050 (d5), K142264 (d5), K133577 (d5), K133650 (d5), K060506 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), K073669 (d5), K100210 (d5), K120991 (d5), K123997 (d5), K140142 (d5), K143740 (d5), K153495 (d5), K140319 (d5), K160916 (d5), K150673 (d5), K151276 (d5), K151773 (d5), K160051 (d5), K141665 (d5), K161230 (d5), K101171 (d5), K142251 (d5), K152532 (d5), K160924 (d5), K162262 (d5), K073177 (d6), K090425 (d6), K062083 (d6), K083475 (d6), K080971 (d6), K092070 (d6), K043479 (d6), K072160 (d6), K090064 (d6), K031729 (d6), K040267 (d6), K042883 (d6), K042993 (d6), K051146 (d6), K051380 (d6), K051977 (d6), K053514 (d6), K061521 (d6), K072221 (d6), K072575 (d6), K123166 (d6), K100175 (d6), K112405 (d6), K113528 (d6), K122591 (d6), K132897 (d6), K121760 (d6), K062151 (d6), K110632 (d6), K113348 (d6), K122967 (d6), K132601 (d6), K090816 (d6), K120918 (d6), K123231 (d6), K130820 (d6), K131082 (d6), K133455 (d6), K120486 (d6), K053340 (d6), K100391 (d6), K072981 (d6), K121982 (d6), K122639 (d6), K131276 (d6), K141942 (d6), K140759 (d6), K143163 (d6), K102606 (d6), K133328 (d6), K142066 (d6), K150053 (d6), K082262 (d6), K090507 (d6), K110327 (d6), K113285 (d6), K142645 (d6), K150643 (d6), K152475 (d6), K100043 (d6), K131723 (d6), K140479 (d6), K153419 (d6), K153782 (d6), K150788 (d6), K151310 (d6), K151322 (d6), K141896 (d6), K151726 (d6), K160955 (d6), K042871 (d7), K052888 (d7), K073348 (d7), K103382 (d7), K031635 (d7), K080568 (d7), K101923 (d7), K090353 (d7), K120368 (d7), K050539 (d7), K063423 (d7), K974556 (d7), K080537 (d7), K023570 (d7), K062933 (d7), K082310 (d7), K091278 (d7), K092193 (d7), K100042 (d7), K130548 (d7), K043206 (d7), K133623 (d7), K001340 (d7), K023835 (d7), K030833 (d7), K052746 (d7), K073649 (d7), K082128 (d7), K110454 (d7), K110694 (d7), K140659 (d7), K101301 (d7), K101310 (d7), K102090 (d7), K111122 (d7), K133200 (d7), K133286 (d7), K120869 (d7), K083661 (d7), K093704 (d7), K093864 (d7), K100865 (d7), K101051 (d7), K141217 (d7), K080281 (d7), K081614 (d7), K122989 (d7), K132700 (d7), K151472 (d7), K103111 (d7), K121649 (d7), K150994 (d7), K090166 (d8), P970015 (d8), K073470 (d8), K080758 (d8), K093242 (d8), K082252 (d8), K072970 (d8), K090899 (d8), K083186 (d8), K033926 (d8), K103731 (d8), K101812 (d8), K040482 (d8), K040928 (d8), K082406 (d8), K092574 (d8), K092901 (d8)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDICREA INTERNATIONAL

  • VAI 2017-02-16 Medicrea International · 5 citations
  • VAI 2013-06-20 Medicrea International · 0 citations
  • VAI 2013-06-19 Medicrea International · 5 citations