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G210 InviCell Plus Incubator

RESEARCH INSTRUMENTS LIMITED · Model G210 · UDI-DI 05060554120130

PUB Prescription
1
510(k) clearances
5
Adverse events
6
Recalls
22
Facilities

Description

The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

Recalls

DateFirmReason
2024-11-15CooperSurgical, 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
2024-11-15CooperSurgical, 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
2024-11-15CooperSurgical, 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
2024-11-15CooperSurgical, 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
2024-11-15CooperSurgical, 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
2024-11-15CooperSurgical, 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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Data 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.