Panels › General Hospital › Product code FMZ · Class 2
Incubator, Neonatal
Regulation 880.5400
2510(k)s in 12 months (86 all time)
3recalls in 12 months (43 all time)
35recalls that name a 510(k)
Top companies in FMZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K020543 K101788 +2 |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX Open, Classified |
FMZ | K152814 K213551 |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models Open, Classified |
FMZ | K020543 K101788 |
| Oct 31, 2024 | DATEX--OHMEDA, INC. GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers:
1) 2082844-002-01040417;
2) 2082844-002-01044956;
3) 2082844-002-01058424;
4) 2082844-002-01069017;
5) 2082844-0 Completed |
FMZ | K152809 K213553 |
| Oct 31, 2024 | DATEX--OHMEDA, INC. GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers:
1) 2082844-001-01040418;
2) 2082844-001-01046784;
3) 2082844-001-01052324;
4) 208284 Completed |
FMZ | K152814 K213551 |
| Oct 17, 2024 | DATEX--OHMEDA, INC. GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator Open, Classified |
FMZ | K152814 K213551 |
| Oct 17, 2024 | DATEX--OHMEDA, INC. GE Heathcare Giraffe OmniBed; neo natal incubator Open, Classified |
FMZ | K020543 K101788 |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare neonatal incubator, models:
a) Lullaby Incubator,
b) Lullaby Incubator XP,
c) Lullaby Incubator TR Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare neonatal incubator, models:
a) Care Plus,
b) Care Plus 1000,
c) Care Plus 2000,
d) Care Plus 3000,
e) Care Plus 4000, Plus 4000 Open, Classified |
FMZ | K871399 K901585 +4 |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Beside panel FRU (Field Replacement Units) Kits 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 | K020543 K101788 |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Giraffe OmniBed Carestation CS1,
Model Numbers:
a. 2082844-001-XXX,
b. 2074920-001-XXXXXX,
c. M1050205,
d. M1135822,
e. M1145475,
f. M1145476,
g. M1235957,
h. M1149051,
i. M1146098;
Labe Open, Classified |
FMZ | K152814 K213551 |
| Jun 30, 2021 | CooperSurgical, Inc. Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers
Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 Terminated |
FMZ | None listed |
| May 22, 2020 | GE Healthcare, LLC Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. Terminated |
FMZ | K101788 |
| Apr 28, 2020 | GE Healthcare, LLC Giraffe Incubator with installed Servo Oxygen module. Infant incubator. Terminated |
FMZ | K010222 K020547 +2 |
| Apr 28, 2020 | GE Healthcare, LLC Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. Terminated |
FMZ | K020543 K101788 |
| Jul 26, 2019 | GE Healthcare, LLC Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both Open, Classified |
FMZ | K152814 |
| Oct 5, 2018 | Ohmeda Medical Giraffe Omnibed - Product Usage: 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 from one mode to Terminated |
FMZ | K993407 |
| Sep 25, 2018 | GE Healthcare, LLC Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 Terminated |
FMZ | K152809 |
| Sep 25, 2018 | GE Healthcare, LLC Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 Terminated |
FMZ | K152814 |
| Nov 18, 2016 | Ohmeda Medical CarePlus Incubator
Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for shor Terminated |
FMZ | K974349 |
| Nov 18, 2016 | Ohmeda Medical Giraffe OmniBed
Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled m Terminated |
FMZ | K993407 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Incubator
Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on t Terminated |
FMZ | K020547 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Incubator
The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators p Terminated |
FMZ | K010222 |
| Oct 7, 2016 | Natus Medical Incorporated The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator.
Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007. Terminated |
FMZ | K070291 |
| Apr 11, 2016 | Natus Medical Incorporated Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. Terminated |
FMZ | K070291 |
| Apr 5, 2013 | GE Healthcare, LLC Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***.
GE Healthcare Giraffe Omnib Terminated |
FMZ | K101778 K101788 |
| Jul 6, 2012 | Atom Medical Corporation Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Infa Warmer i (Atom Infant Warmer Model 103)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: A warmer for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Rabee Incu i (Atom Infant Incubator Model 102)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: An incubator for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Incu i (Atom Infant Incubator Model 101)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: An incubator for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Dual Incu i (Atom Infant Incubator Model 100)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: A combination incubator and warmer for infants. Terminated |
FMZ | K102226 |
| Jun 13, 2011 | Maquet Datascope Corp - Cardiac Assist Division Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump;
Manufactured by Datascope Corp., 1300 MacArthur Blvd., M Terminated |
FMZ | K031636 K063525 +1 |
| Nov 21, 2008 | Datex Ohmeda, Inc. dba GE Healthcare Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***.
The OmniBed is a combination of an infant incubator and an infant warmer. The d Terminated |
FMZ | None listed |
| Mar 18, 2008 | Draeger Medical, Inc. Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969 Terminated |
FMZ | K001019 |
| Mar 18, 2008 | Draeger Medical, Inc. Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, Inc., Telford, PA 18969 Terminated |
FMZ | K001019 |
| Mar 18, 2008 | Draeger Medical, Inc. Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969 Terminated |
FMZ | K941106 |
| Jul 28, 2005 | Ohmeda Medical, A division of Datex-Ohmeda, Inc. Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators Terminated |
FMZ | K010222 K020543 +2 |
| 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 | K020543 |
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