FMZ

Product Code: FMZ


Products Classified as FMZ

2561Incubator, NeonatalNeonatal Incubator.

Total Product Life Cycle (TPLC) Devices

2561Incubator, NeonatalNeonatal Incubator.

FDA Consensus Standards

Incubator, Neonatal [36981]21 CFR §880.5400 🔎

Pre-market Notifications for FMZ

K213553Giraffe Incubator Carestation CS1Datex Ohmeda Inc.
K190494Infant IncubatorNingbo David Medical Device Co.,Ltd
K182977Isolette 8000 PlusDraeger Medical Systems, Inc.
K182859Babyleo TN500Dragerwerk AG & Co. KGaA
K172154Isolette 8000 PlusDraeger Medical Sytems, Inc.
K162821Babyleo TN500Draegerwerk AG & Co. KGaA
K152809Giraffe Incubator Carestation CS1OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division Of Datex-Ohmeda,Inc. A GE Company
K132543INFANT INCUBATORBISTOS CO., LTD.
K102710NEO-SERVO IATOM MEDICAL CORPORATION
K102279INCU IATOM MEDICAL CORPORATION
K102226DUAL INCU IATOM MEDICAL CORPORATION
K101778GIRAFFE INCUBATOROHMEDA MEDICAL
K101788GIRAFFE OMNIBEDOHMEDA MEDICAL
K072512MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)DATEX-OHMEDA, INC.

Global Unique Device Identification Database

10854758006206Incubator, Neonatal
10854758006190Incubator, Neonatal
00854758006186Incubator, Neonatal
10854758006114Incubator, Neonatal
00854758006100Incubator, Neonatal
00854758006094Incubator, Neonatal
00854758006070Incubator, Neonatal
00854758006056Incubator, Neonatal
20854758006043Incubator, Neonatal
20854758006036Incubator, Neonatal
04942962616461Incubator, Neonatal
04942962616225Incubator, Neonatal
04942962616218Incubator, Neonatal
04942962616157Incubator, Neonatal
04942962616072Incubator, Neonatal

Maude Adverse Events

GIRAFFE OMNIBED CARESTATIONDATEX-OHMEDA, INC2020-03-10
GIRAFFE OMNIBED GE MEDICAL INCUBATOR/INFANT WARMERGE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS2020-01-15
GIRAFFE OMNIBEDGE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE2019-10-24
GIRAFFE OMNIBEDGE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE2019-10-18
GIRAFFE OMNIBEDGE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE2019-10-15
GE HEALTHCARE ISOLETTEDATEX-OHMEDA INC2019-10-09
GIRAFFE OMNIBED CARESTATIONDATEX-OHMEDA, INC.2019-10-02
GIRAFFE OMNIBED CARESTATIONDATEX-OHMEDA INC2019-10-02
GIRAFFE INCUBATORDATEX-OHMEDA, INC.2019-09-27
GIRAFFE OMNIBEDOHMEDA MEDICAL2019-09-25
GIRAFFE OMNIBEDOHMEDA MEDICAL2019-09-25
GIRAFFE INCUBATOROHMEDA MEDICAL2019-09-24
GIRAFFE OMNIBED CARESTATIONGE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS LLC2019-09-23
GIRAFFE OMNIBEDOHMEDA MEDICAL2019-09-23
GIRAFFE INCUBATORDATEX-OHMEDA, INC.2019-09-20
GIRAFFE INCUBATORDATEX-OHMEDA, INC.2019-09-20
GIRAFFE INCUBATORDATEX-OHMEDA, INC.2019-09-20
GIRAFFE INCUBATORDATEX-OHMEDA, INC.2019-09-20
GE GIRAFFE INFANT INCUBATORGE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC2019-09-03
GIRAFFE OMNIBED CARESTATION CSIGE HEALTHCARE / GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC2019-08-07
AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?)VYAIRE MEDICAL2019-07-16
AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?)VYAIRE MEDICAL2019-07-16
BABYLEO TN500DR?GERWERK AG & CO. KGAA2019-07-05
GIRAFFE OMNIBEDOHMEDA MEDICAL2019-03-26
GIRAFFE OMNIBEDOHMEDA MEDICAL2019-01-23
GIRAFFE OMNIBEDOHMEDA MEDICAL2019-01-22
GIRAFFE OMNIBED CARESTATIONOHMEDA MEDICAL2018-12-19
AIRLIFE? INFANT SKIN TEMPERATURE PROBE, SINGLE PATIENT USE (GIRAFFE?, PANDA?)VYAIRE MEDICAL2018-11-08
GIRAFFE OMNIBED CARESTATIONOHMEDA MEDICAL2018-10-05
AIRLIFECAREFUSION FINLAND 320 OY2018-10-02
GE GIRAFFE INCUBATOR CARESTATIONGENERAL ELECTRIC CO.2018-08-24
AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?)VYAIRE MEDICAL2018-08-13
GIRAFFE OMNIBEDOHMEDA MEDICAL2018-07-20
GIRAFFE OMNIBEDOHMEDA MEDICAL2018-07-20
GIRAFFE OMNIBEDOHMEDA MEDICAL2018-07-20
GIRAFFE OMNIBEDOHMEDA MEDICAL2018-07-20
GIRAFFE OMNIBEDOHMEDA MEDICAL2018-07-20
GIRAFFE OMNIBEDOHMEDA MEDICAL2018-07-20
GIRAFFE OMNIBED CARESTATIONOHMEDA MEDICAL2018-06-19
HILL-ROM/ AIRSHIELDS-DRAGERDRAEGER MEDICAL SYSTEM, INC.2018-06-07
BILIBLANKET PLUS HIGH OUTPUTOHMEDA MEDICAL2018-06-06
CALEODR?GERWERK AG & CO. KGAA2018-04-06
CALEODR?GERWERK AG & CO. KGAA2018-04-06
PHILIPS RESPIRONICSPHILIPS RESPIRONICS2018-02-02
DRAEGERDRAEGER MEDICAL SYSTEMS, INC.2018-01-19
POSITIONER SPIDER LIMBSMITH & NEPHEW, INC.2017-09-28
GIRAFFE OMNIBEDOHMEDA MEDICAL2017-09-12
GIRAFFE INCUBATOR; GIRAFFE INCUBATOR + SHUTTLEOHMEDA MEDICAL2017-08-31
GIRAFFE ISOLETTEGE HEALTHCARE - HEALTHCARE SERVICES DATEX-OHMEDA2017-07-18
GIRAFFE SHUTTLEOHMEDA MEDICAL2017-06-06

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