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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2026 | K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) Datex-Ohmeda, Inc. | FMZ |
| Feb 13, 2026 | K251619 | Babyleo TN500 Drägerwerk AG & Co. KGaA, DE | FMZ |
| Oct 22, 2025 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) Datex-Ohmeda, Inc. | FMZ |
| Aug 14, 2025 | K243437 | mOm Essential Incubator (ME1) Mom Incubators Limited, GB | FMZ |
| Mar 2, 2022 | K213553 | Giraffe Incubator Carestation CS1 Datex Ohmeda, Inc. | FMZ |
| Nov 25, 2019 | K190494 | Infant Incubator Ningbo David Medical Device Co., Ltd., CN | FMZ |
| Feb 22, 2019 | K182859 | Babyleo TN500 Dragerwerk AG & CO Kgaa, DE | FMZ |
| Nov 21, 2018 | K182977 | Isolette 8000 Plus Draeger Medical Systems, Inc. | FMZ |
| Apr 19, 2018 | K172154 | Isolette 8000 plus Draeger Medical Sytems, Inc. | FMZ |
| Jun 23, 2017 | K162821 | Babyleo TN500 Draegerwerk AG & CO Kgaa, DE | FMZ |
| Mar 17, 2016 | K152814 | Giraffe OmniBed Carestation CS1 Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | FMZ |
| Dec 31, 2015 | K152809 | Giraffe Incubator Carestation CS1 Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | FMZ |
| Jul 3, 2014 | K132543 | INFANT INCUBATOR Bistos Co., Ltd. | FMZ |
| Jan 4, 2011 | K102226 | DUAL INCU I Atom Medical Corporation, JP | FMZ |
| Dec 29, 2010 | K102279 | INCU I Atom Medical Corporation, JP | FMZ |
| Dec 22, 2010 | K102710 | NEO-SERVO I Atom Medical Corporation | FMZ |
| Jul 21, 2010 | K101788 | GIRAFFE OMNIBED Ohmeda Medical | FMZ |
| Jul 21, 2010 | K101778 | GIRAFFE INCUBATOR Ohmeda Medical | FMZ |
| May 23, 2008 | K071977 | TARRY MEDICAL TEMPERATURE PROBES Tarry Medical Products, Inc. | FMZ |
| Oct 3, 2007 | K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) Datex-Ohmeda, Inc. | FMZ |
| Sep 21, 2007 | K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX Medix I.C.S.A. | FMZ |
| Jul 17, 2007 | K071175 | OHMEDA MEDICAL GIRAFFE OMNIBED GE Healthcare | FMZ |
| Sep 28, 2006 | K061856 | V-2200 INFANT INCUBATOR Atom Medical, Inc. | FMZ |
| Aug 4, 2006 | K053399 | VERSALET 7700 CARE CENTER Draeger Medical Infant Care, Inc. | FMZ |
| Jun 27, 2006 | K061280 | V-2200 INFANT INCUBATOR Neoforce Group, Inc. | FMZ |
| Apr 21, 2004 | K040910 | INFANT INCUBATOR, MODEL CHS-I1000 Choong Wae Medical Corp. | FMZ |
| Apr 16, 2004 | K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM Ohmeda Medical | FMZ |
| Aug 1, 2003 | K031387 | ISOLETTE INFANT INCUBATOR, MODEL C2000E Hill-Rom Manufacturing, Inc. | FMZ |
| Jul 18, 2002 | K021809 | V-2100G ADVANCED INFANT INCUBATOR Atom Medical Corp | FMZ |
| May 9, 2002 | K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR Ohmeda Medical | FMZ |
| May 9, 2002 | K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED Ohmeda Medical | FMZ |
| Mar 21, 2001 | K010222 | OHMEDA MEDICAL GIRAFFE INCUBATOR Ohmeda Medical | FMZ |
| Dec 13, 2000 | K003067 | CALEO Drager Medizintechnik GmbH | FMZ |
| Jul 13, 2000 | K001242 | ISOLETTE INFANT INCUBATOR, MODEL C2HS Hill-Rom Air-Shields | FMZ |
| Feb 3, 2000 | K993051 | VERSALET 7700 CARE CENTER, MODEL # 7700 Hill-Rom Air-Shields | FMZ |
| Jan 5, 2000 | K993407 | OHMEDA MEDICAL OMNIBED Ohmeda Medical | FMZ |
| Nov 9, 1999 | K993712 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM Ohmeda Medical | FMZ |
| May 29, 1998 | K980886 | BABYTHERM 8000 LDR Draeger Medical, Inc. | FMZ |
| Feb 12, 1998 | K974349 | OHMEDA-OHIO CARE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Apr 25, 1997 | K954204 | DRAGER INCUBATOR 8000 IC Drager, Inc. | FMZ |
| Sep 20, 1996 | K962806 | OHMEDA-OHIO CAE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Jul 30, 1996 | K960980 | ISOLETTE INFANT INCUBATOR Air-Shields, Inc. | FMZ |
| Sep 29, 1994 | K943360 | OHIO CARE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Jun 23, 1994 | K940975 | C450/C400 INFANT INCUBATORS Air-Shields, Inc. | FMZ |
| Nov 12, 1993 | K924324 | K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE K-1 Medical Products, Inc. | FMZ |
| Aug 19, 1993 | K922618 | BOWRON G.L. Bowron & Co. , Ltd. | FMZ |
| May 21, 1993 | K920049 | MEDIX PC-305 NEONATAL INCUBATOR Medix I.C.S.A., AR | FMZ |
| Mar 18, 1993 | K924297 | DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER Air-Shields Vickers, Inc. | FMZ |
| Feb 5, 1993 | K924170 | ISOLETTE INCUBATOR HUMIDITY METER Air-Shields, Inc. | FMZ |
| Sep 21, 1992 | K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER S & W Medico Teknik, DK | FMZ |
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