510(k) K020543 ยท FMZ Incubator, Neonatal
OHMEDA MEDICAL GIRAFFE OMNIBED
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, May 9, 2002 |
| Received | Feb 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models Open, Classified |
FMZ | None listed |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 Open, Classified |
FMZ | None listed |
| Oct 17, 2024 | DATEX--OHMEDA, INC. GE Heathcare Giraffe OmniBed; neo natal incubator Open, Classified |
FMZ | None listed |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901 Open, Classified |
FMZ | None listed |
| Apr 28, 2020 | GE Healthcare, LLC Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. Terminated |
FMZ | None listed |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe OmniBed infant warmer Terminated |
FMT | None listed |
| Nov 18, 2016 | Ohmeda Medical Giraffe OmniBed
Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition f Terminated |
FMT | None listed |
| Jul 28, 2005 | Ohmeda Medical, A division of Datex-Ohmeda, Inc. Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators Terminated |
FMZ | None listed |
| Jul 20, 2004 | Ohmeda Medical, A Div of Datex-Ohmeda , Inc Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed. Terminated |
FMZ | None listed |
| Jul 29, 2003 | Ohmeda Medical, A division of Datex-Ohmeda, Inc. Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators Terminated |
80F | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.