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)
Top companies in FMT
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare | 1 | 19 |
| Ohmeda Medical | 10 | 5 |
| Contour Medical Technology, Inc. | 6 | 0 |
| Draeger Medical Systems, Inc. | 3 | 3 |
| Air-Shields, Inc. | 5 | 0 |
| Atom Medical Corp | 4 | 0 |
| Deroyal Industries, Inc. | 3 | 1 |
| Fisher & Paykel Electronics , Ltd. | 4 | 0 |
| Gempco, Inc. | 4 | 0 |
| Hill-Rom, Inc. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Datex-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 |
FMT | K123309 |
| Jun 18, 2026 | Datex-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 |
FMT | K201628 |
| Sep 20, 2024 | Wipro 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 |
FMT | K201628 |
| Sep 20, 2024 | Wipro 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 |
FMT | K201628 |
| Jun 22, 2023 | Draeger 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 |
FMT | K120642 |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe Incubator infant warmer Terminated |
FMT | None listed |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer Terminated |
FMT | K152809 |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer Terminated |
FMT | K152814 |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe OmniBed infant warmer Terminated |
FMT | K020543 K101788 |
| Jul 11, 2019 | GE 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 |
FMT | K123309 |
| Jul 11, 2019 | GE 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 |
FMT | K123309 |
| Sep 25, 2018 | GE Healthcare, LLC Panda Wall Mount warmer. Infant radiant warmer Terminated |
FMT | K070377 K090697 +3 |
| Sep 25, 2018 | GE 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 |
FMT | K070377 K090697 +3 |
| Sep 25, 2018 | GE Healthcare, LLC Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer. Terminated |
FMT | K070377 K090697 +3 |
| Sep 25, 2018 | GE Healthcare, LLC Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer. Terminated |
FMT | K070377 K090697 +3 |
| May 19, 2017 | GE Healthcare, LLC Infant Warmer System (IWS) Terminated |
FMT | K840858 K851449 +3 |
| Nov 18, 2016 | Ohmeda 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 |
FMT | K963058 |
| Nov 18, 2016 | Ohmeda 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 |
FMT | K090697 |
| Nov 18, 2016 | Ohmeda 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 |
FMT | K072157 |
| Nov 18, 2016 | Ohmeda 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 |
FMT | K070377 |
| 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 | K020543 |
| Aug 4, 2016 | GE Healthcare, LLC Infant Warmer System (IWS) Terminated |
FMT | K963058 |
| Jun 22, 2016 | Draeger 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 |
FMT | K971198 |
| Nov 30, 2015 | DeRoyal Industries Inc HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. Terminated |
FMT | K925006 |
| Nov 13, 2014 | Fisher & 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 |
FMT | K970432 K971461 |
| May 6, 2014 | GE 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 |
FMT | None listed |
| May 6, 2014 | GE 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 |
FMT | K122267 K123309 |
| May 6, 2014 | GE 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 |
FMT | K122267 K123309 |
| May 6, 2014 | GE 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 |
FMT | K122267 K123309 |
| May 6, 2014 | GE 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 |
FMT | K122267 K123309 |
| Feb 3, 2014 | GE 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 |
FMT | K123309 |
| Feb 3, 2014 | GE 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 |
FMT | K123309 |
| Aug 26, 2009 | Draeger Medical Systems, Inc. Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only. Terminated |
FMT | K003335 |
| Aug 25, 2009 | Draeger Medical Systems, Inc. Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200. Terminated |
FMT | K042607 K850069 +1 |
| Sep 11, 2008 | Datex 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 |
FMT | K070377 |
| Jan 11, 2007 | Fisher & Paykel Healthcare Ltd Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module Terminated |
FMT | K970432 |
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