Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

CONVIVO

Model 6918 · Carl Zeiss Meditec AG · DI 04049539069184

GWG — Endoscope, Neurological · Class II · 21 CFR 882.1480

LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050

OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-16 · 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.

4711142019-01: 0 reports for this device; peer average 4/device2019-02: 0 reports for this device; peer average 11.5/device2019-03: 0 reports for this device; peer average 6.4/device2019-04: 0 reports for this device; peer average 5.69/device2019-05: 0 reports for this device; peer average 12.13/device2019-06: 0 reports for this device; peer average 7.31/device2019-07: 0 reports for this device; peer average 6.55/device2019-08: 0 reports for this device; peer average 14.09/device2019-09: 0 reports for this device; peer average 6.67/device2019-10: 0 reports for this device; peer average 6.22/device2019-11: 0 reports for this device; peer average 7.75/device2019-12: 0 reports for this device; peer average 11.5/device2020-01: 0 reports for this device; peer average 3.64/device2020-02: 0 reports for this device; peer average 8.21/device2020-03: 0 reports for this device; peer average 7.88/device2020-04: 0 reports for this device; peer average 13.22/device2020-05: 0 reports for this device; peer average 4.45/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 3.06/device2020-08: 0 reports for this device; peer average 2.95/device2020-09: 0 reports for this device; peer average 2.05/device2020-10: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 2.3/device2020-12: 0 reports for this device; peer average 2.89/device2021-01: 0 reports for this device; peer average 3.06/device2021-02: 0 reports for this device; peer average 2.63/device2021-03: 0 reports for this device; peer average 3.18/device2021-04: 0 reports for this device; peer average 3.81/device2021-05: 0 reports for this device; peer average 3.7/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 4/device2021-08: 0 reports for this device; peer average 3.7/device2021-09: 0 reports for this device; peer average 3.07/device2021-10: 0 reports for this device; peer average 3.33/device2021-11: 0 reports for this device; peer average 3.32/device2021-12: 0 reports for this device; peer average 4.94/device2022-01: 0 reports for this device; peer average 3.5/device2022-02: 0 reports for this device; peer average 4.2/device2022-03: 0 reports for this device; peer average 4.81/device2022-04: 0 reports for this device; peer average 3.19/device2022-05: 0 reports for this device; peer average 6.88/device2022-06: 0 reports for this device; peer average 6.11/device2022-07: 0 reports for this device; peer average 3.84/device2022-08: 0 reports for this device; peer average 3.57/device2022-09: 0 reports for this device; peer average 3.3/device2022-10: 0 reports for this device; peer average 3.67/device2022-11: 0 reports for this device; peer average 3.86/device2022-12: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 3.3/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 4.04/device2023-04: 0 reports for this device; peer average 3.78/device2023-05: 0 reports for this device; peer average 3.54/device2023-06: 0 reports for this device; peer average 3.6/device2023-07: 0 reports for this device; peer average 3.85/device2023-08: 0 reports for this device; peer average 4.47/device2023-09: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 5/device2023-11: 0 reports for this device; peer average 4.03/device2023-12: 0 reports for this device; peer average 3.77/device2024-01: 0 reports for this device; peer average 4.25/device2024-02: 0 reports for this device; peer average 6.48/device2024-03: 0 reports for this device; peer average 5.41/device2024-04: 0 reports for this device; peer average 6.68/device2024-05: 0 reports for this device; peer average 4.65/device2024-06: 0 reports for this device; peer average 5.56/device2024-07: 0 reports for this device; peer average 6.88/device2024-08: 0 reports for this device; peer average 6/device2024-09: 0 reports for this device; peer average 5.4/device2024-10: 0 reports for this device; peer average 6.04/device2024-11: 0 reports for this device; peer average 4.07/device2024-12: 0 reports for this device; peer average 4.13/device2025-01: 0 reports for this device; peer average 6.49/device2025-02: 0 reports for this device; peer average 5.53/device2025-03: 0 reports for this device; peer average 3.1/device2025-04: 0 reports for this device; peer average 3.03/device2025-05: 0 reports for this device; peer average 2.91/device2025-06: 0 reports for this device; peer average 3.17/device2025-07: 0 reports for this device; peer average 3.97/device2025-08: 0 reports for this device; peer average 4.3/device2025-09: 0 reports for this device; peer average 2.84/device2025-10: 0 reports for this device; peer average 7.04/device2025-11: 0 reports for this device; peer average 3.16/device2025-12: 0 reports for this device; peer average 5.49/device2026-01: 0 reports for this device; peer average 6.14/device2026-02: 0 reports for this device; peer average 3.91/device2026-03: 0 reports for this device; peer average 10.58/device2026-04: 0 reports for this device; peer average 9.86/device2026-05: 0 reports for this device; peer average 12.2/device2026-06: 0 reports for this device; peer average 6.9/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-02011.5
2019-0306.4
2019-0405.69
2019-05012.13
2019-0607.31
2019-0706.55
2019-08014.09
2019-0906.67
2019-1006.22
2019-1107.75
2019-12011.5
2020-0103.64
2020-0208.21
2020-0307.88
2020-04013.22
2020-0504.45
2020-0603
2020-0703.06
2020-0802.95
2020-0902.05
2020-1003
2020-1102.3
2020-1202.89
2021-0103.06
2021-0202.63
2021-0303.18
2021-0403.81
2021-0503.7
2021-0603
2021-0704
2021-0803.7
2021-0903.07
2021-1003.33
2021-1103.32
2021-1204.94
2022-0103.5
2022-0204.2
2022-0304.81
2022-0403.19
2022-0506.88
2022-0606.11
2022-0703.84
2022-0803.57
2022-0903.3
2022-1003.67
2022-1103.86
2022-1203
2023-0103.3
2023-0203
2023-0304.04
2023-0403.78
2023-0503.54
2023-0603.6
2023-0703.85
2023-0804.47
2023-0904
2023-1005
2023-1104.03
2023-1203.77
2024-0104.25
2024-0206.48
2024-0305.41
2024-0406.68
2024-0504.65
2024-0605.56
2024-0706.88
2024-0806
2024-0905.4
2024-1006.04
2024-1104.07
2024-1204.13
2025-0106.49
2025-0205.53
2025-0303.1
2025-0403.03
2025-0502.91
2025-0603.17
2025-0703.97
2025-0804.3
2025-0902.84
2025-1007.04
2025-1103.16
2025-1205.49
2026-0106.14
2026-0203.91
2026-03010.58
2026-0409.86
2026-05012.2
2026-0606.9
This device (reports/month)Average device in GWG, LLZ, OWN (reports/device/month)

Regulatory clearances

  • K211156 SESE 2021-12-29 (k number procode)
  • K181116 SESE 2018-10-25 (k number procode)

Predicate lineage

K181116 — cites (transitively): K162991 (d1), K180270 (d1), K111047 (d2), K133466 (d2), K150831 (d2), K161112 (d2), K172844 (d2), K051585 (d3), K061666 (d3), K122042 (d3), K123673 (d3), K123676 (d3), K132389 (d3), K141358 (d3), K002788 (d3), K160044 (d3), K151593 (d3), K160416 (d3), K171345 (d3), K050403 (d4), K052194 (d4), K120208 (d4), K092359 (d4), K011496 (d4), K043022 (d4), K091962 (d4), K013165 (d4), K131953 (d4), K070716 (d5) — cited as predicate by K191144, K211156

K211156 — cites (transitively): K181116 (d1), K202229 (d1), K162991 (d2), K180270 (d2), K142647 (d2), K111642 (d3), K133644 (d3), K111047 (d3), K133466 (d3), K150831 (d3), K161112 (d3), K172844 (d3), K051585 (d4), K061666 (d4), K081985 (d4), K123577 (d4), K122042 (d4), K123673 (d4), K123676 (d4), K132389 (d4), K141358 (d4), K002788 (d4), K160044 (d4), K151593 (d4), K160416 (d4), K171345 (d4), K050403 (d5), K052194 (d5), K120208 (d5), K092359 (d5), K011496 (d5), K043022 (d5), K091962 (d5), K013165 (d5), K131953 (d5), K070716 (d6)

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

Manufacturer compliance record — Carl Zeiss Meditec AG

  • NAI 2024-03-26 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2018-10-25 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2017-02-24 Carl Zeiss Meditec AG · 0 citations
  • NAI 2016-03-25 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2014-09-18 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2014-08-15 Carl Zeiss Meditec AG · 0 citations
  • NAI 2014-03-26 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2011-11-17 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2011-06-22 Carl Zeiss Meditec Inc. · 0 citations