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Panels › General Hospital › Product code FMT · Class 2

Warmer, Infant Radiant

Regulation 880.5130

0510(k)s in 12 months (92 all time)
2recalls in 12 months (36 all time)
34recalls that name a 510(k)
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Top companies in FMT

DateFirm and productCodeLinked 510(k)
Jun 18, 2026Datex-Ohmeda Inc
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Open, Classified
FMTK123309
Jun 18, 2026Datex-Ohmeda Inc
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-
Open, Classified
FMTK201628
Sep 20, 2024Wipro GE Healthcare Private Ltd.
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-010
Open, Classified
FMTK201628
Sep 20, 2024Wipro GE Healthcare Private Ltd.
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiolo
Open, Classified
FMTK201628
Jun 22, 2023Draeger Medical Systems, Inc.
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
Open, Classified
FMTK120642
Dec 3, 2019GE Healthcare, LLC
Giraffe Incubator infant warmer
Terminated
FMTNone listed
Dec 3, 2019GE Healthcare, LLC
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
Terminated
FMTK152809
Dec 3, 2019GE Healthcare, LLC
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
Terminated
FMTK152814
Dec 3, 2019GE Healthcare, LLC
Giraffe OmniBed infant warmer
Terminated
FMTK020543
K101788
Jul 11, 2019GE Healthcare, LLC
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may
Terminated
FMTK123309
Jul 11, 2019GE Healthcare, LLC
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers m
Terminated
FMTK123309
Sep 25, 2018GE Healthcare, LLC
Panda Wall Mount warmer. Infant radiant warmer
Terminated
FMTK070377
K090697 +3
Sep 25, 2018GE Healthcare, LLC
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
Terminated
FMTK070377
K090697 +3
Sep 25, 2018GE Healthcare, LLC
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Terminated
FMTK070377
K090697 +3
Sep 25, 2018GE Healthcare, LLC
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Terminated
FMTK070377
K090697 +3
May 19, 2017GE Healthcare, LLC
Infant Warmer System (IWS)
Terminated
FMTK840858
K851449 +3
Nov 18, 2016Ohmeda Medical
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat t
Terminated
FMTK963058
Nov 18, 2016Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on
Terminated
FMTK090697
Nov 18, 2016Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to
Terminated
FMTK072157
Nov 18, 2016Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physio
Terminated
FMTK070377
Nov 18, 2016Ohmeda 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
FMTK020543
Aug 4, 2016GE Healthcare, LLC
Infant Warmer System (IWS)
Terminated
FMTK963058
Jun 22, 2016Draeger Medical, Inc.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010
Terminated
FMTK971198
Nov 30, 2015DeRoyal Industries Inc
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
Terminated
FMTK925006
Nov 13, 2014Fisher & Paykel Healthcare, Ltd.
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infan
Terminated
FMTK970432
K971461
May 6, 2014GE Healthcare
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat
Terminated
FMTNone listed
May 6, 2014GE Healthcare
Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature
Terminated
FMTK122267
K123309
May 6, 2014GE Healthcare
Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring featur
Terminated
FMTK122267
K123309
May 6, 2014GE Healthcare
Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used fo
Terminated
FMTK122267
K123309
May 6, 2014GE Healthcare
Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for c
Terminated
FMTK122267
K123309
Feb 3, 2014GE Healthcare
Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda
Terminated
FMTK123309
Feb 3, 2014GE Healthcare
Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared heat in a controlled
Terminated
FMTK123309
Aug 26, 2009Draeger Medical Systems, Inc.
Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.
Terminated
FMTK003335
Aug 25, 2009Draeger Medical Systems, Inc.
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
Terminated
FMTK042607
K850069 +1
Sep 11, 2008Datex Ohmeda, Inc. dba GE Healthcare
Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant warmers provide infrared heat in a controlled
Terminated
FMTK070377
Jan 11, 2007Fisher & Paykel Healthcare Ltd
Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
Terminated
FMTK970432

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