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K-Systems
RESEARCH INSTRUMENTS LIMITED · Model G210 InviCell · UDI-DI 05060554120963
1
510(k) clearances
5
Adverse events
6
Recalls
21
Facilities
Description
IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
| 2024-11-15 | CooperSurgical, Inc. | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will al |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.