ClearanceBrief
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)
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Top companies in FMZ

DateFirm and productCodeLinked 510(k)
Jun 17, 2026GE Medical Systems, LLC
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Open, Classified
FMZK020543
K101788 +2
Jun 17, 2026GE 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
FMZK152814
K213551
Jun 17, 2026GE Medical Systems, LLC
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Open, Classified
FMZK020543
K101788
Oct 31, 2024DATEX--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
FMZK152809
K213553
Oct 31, 2024DATEX--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
FMZK152814
K213551
Oct 17, 2024DATEX--OHMEDA, INC.
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Open, Classified
FMZK152814
K213551
Oct 17, 2024DATEX--OHMEDA, INC.
GE Heathcare Giraffe OmniBed; neo natal incubator
Open, Classified
FMZK020543
K101788
Feb 9, 2024Wipro GE Healthcare Private Ltd.
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Open, Classified
FMZNone listed
Feb 9, 2024Wipro GE Healthcare Private Ltd.
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
Open, Classified
FMZNone listed
Feb 9, 2024Wipro 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
FMZNone listed
Feb 9, 2024Wipro 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
FMZNone listed
Feb 9, 2024Wipro GE Healthcare Private Ltd.
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
Open, Classified
FMZNone listed
Feb 9, 2024Wipro 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
FMZK871399
K901585 +4
Jul 6, 2023DATEX--OHMEDA, INC.
Beside panel FRU (Field Replacement Units) Kits
Open, Classified
FMZNone listed
Jul 6, 2023DATEX--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
FMZK020543
K101788
Jul 6, 2023DATEX--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
FMZK152814
K213551
Jun 30, 2021CooperSurgical, 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
FMZNone listed
May 22, 2020GE Healthcare, LLC
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Terminated
FMZK101788
Apr 28, 2020GE Healthcare, LLC
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Terminated
FMZK010222
K020547 +2
Apr 28, 2020GE Healthcare, LLC
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Terminated
FMZK020543
K101788
Jul 26, 2019GE 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
FMZK152814
Oct 5, 2018Ohmeda 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
FMZK993407
Sep 25, 2018GE Healthcare, LLC
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Terminated
FMZK152809
Sep 25, 2018GE Healthcare, LLC
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Terminated
FMZK152814
Nov 18, 2016Ohmeda 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
FMZK974349
Nov 18, 2016Ohmeda 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
FMZK993407
Nov 18, 2016Ohmeda 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
FMZK020547
Nov 18, 2016Ohmeda 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
FMZK010222
Oct 7, 2016Natus Medical Incorporated
The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
Terminated
FMZK070291
Apr 11, 2016Natus Medical Incorporated
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Terminated
FMZK070291
Apr 5, 2013GE 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
FMZK101778
K101788
Jul 6, 2012Atom 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
FMZK102226
Dec 1, 2011Atom 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
FMZK102226
Dec 1, 2011Atom 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
FMZK102226
Dec 1, 2011Atom 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
FMZK102226
Dec 1, 2011Atom 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
FMZK102226
Jun 13, 2011Maquet 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
FMZK031636
K063525 +1
Nov 21, 2008Datex 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
FMZNone listed
Mar 18, 2008Draeger Medical, Inc.
Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969
Terminated
FMZK001019
Mar 18, 2008Draeger Medical, Inc.
Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, Inc., Telford, PA 18969
Terminated
FMZK001019
Mar 18, 2008Draeger Medical, Inc.
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Terminated
FMZK941106
Jul 28, 2005Ohmeda Medical, A division of Datex-Ohmeda, Inc.
Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
Terminated
FMZK010222
K020543 +2
Jul 20, 2004Ohmeda Medical, A Div of Datex-Ohmeda , Inc
Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
Terminated
FMZK020543

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