Home › Device types › FMZ
Incubator, Neonatal
FDA product code FMZ · Class 2 · General Hospital
75
Registered devices
888
Adverse events
43
Recalls
86
510(k) clearances
Devices with this code
Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Airlife — AirLife Finland OyADVANCED INFANT WARMER — ADVANCED INSTRUMENTATIONS, INC.ADVANCED NEONATAL INCUBATOR — ADVANCED INSTRUMENTATIONS, INC.SpO2 Unit(Masimo) — ATOM MEDICAL CORPORATIONOxyTrace Incu — Drägerwerk AG & Co. KGaATarry Probes — TARRY MEDICAL PRODUCTS, INC.Midas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSGiraffe — Datex-Ohmeda, Inc.Isolette Infant Incubator, Models C2000 and C2000e — DRAEGER MEDICAL SYSTEMS, INC.AirLife — Carefusion Finland 320 OyAirLife™ — AirLife Finland OyAirLife — Carefusion Finland 320 OySpO2 Unit(Nellcor) — ATOM MEDICAL CORPORATIONTarry Probes — TARRY MEDICAL PRODUCTS, INC.Skin Temp Probe, 10mm O.D.(Y) — ATOM MEDICAL CORPORATIONMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSIsolette® 8000 plus — DRAEGER MEDICAL SYSTEMS, INC.Babyleo TN500 — Drägerwerk AG & Co. KGaADispo Skin Temp Probe(Y) (10 pcs/box) — ATOM MEDICAL CORPORATIONTarry Probes — TARRY MEDICAL PRODUCTS, INC.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Neo-Servo i Atom Infant Incubator Model 102 — ATOM MEDICAL CORPORATIONAccess Medical Probes — TARRY MEDICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-01 | GE Medical Systems, LLC | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for examp |
| 2026-05-01 | GE Medical Systems, LLC | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for examp |
| 2026-05-01 | GE Medical Systems, LLC | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for examp |
| 2024-09-03 | DATEX--OHMEDA, INC. | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer |
| 2024-09-03 | DATEX--OHMEDA, INC. | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator |
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