CONVIVO · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

510(k)K211156Substantially equivalent (SESE) · 2021-12-29clearance family
510(k)K181116Substantially equivalent (SESE) · 2018-10-25clearance family

Predicate lineage

K181116
- K162991
- K180270

Cited as predicate by: K191144, K211156

K211156
- K181116
  - K162991
  - K180270
- K202229
  - K142647
    - K111642
      - K081985
    - K133644
      - K123577

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility
2024-03-26	NAI	No action indicated	Carl Zeiss Meditec Inc.
2018-10-25	NAI	No action indicated	Carl Zeiss Meditec Inc.
2017-02-24	NAI	No action indicated	Carl Zeiss Meditec AG
2016-03-25	NAI	No action indicated	Carl Zeiss Meditec Inc.
2014-09-18	NAI	No action indicated	Carl Zeiss Meditec Inc.
2014-08-15	NAI	No action indicated	Carl Zeiss Meditec AG
2014-03-26	NAI	No action indicated	Carl Zeiss Meditec Inc.
2011-11-17	NAI	No action indicated	Carl Zeiss Meditec Inc.
2011-06-22	NAI	No action indicated	Carl Zeiss Meditec Inc.

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