FMZ
Babyleo TN500
- Advisory panel
- General Hospital
- Total cleared
- 85
Adverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FMZ
- K251619 — Babyleo TN500
- K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K243437 — mOm Essential Incubator (ME1)
- K213553 — Giraffe Incubator Carestation CS1
- K190494 — Infant Incubator
- K182859 — Babyleo TN500
- K182977 — Isolette 8000 Plus
- K172154 — Isolette 8000 plus
- K162821 — Babyleo TN500
- K152814 — Giraffe OmniBed Carestation CS1
- K152809 — Giraffe Incubator Carestation CS1
- K132543 — INFANT INCUBATOR
- K102226 — DUAL INCU I
- K102279 — INCU I
- K102710 — NEO-SERVO I
- K101778 — GIRAFFE INCUBATOR
- K101788 — GIRAFFE OMNIBED
- K071977 — TARRY MEDICAL TEMPERATURE PROBES
- K072512 — MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
- K071175 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K061856 — V-2200 INFANT INCUBATOR
- K053399 — VERSALET 7700 CARE CENTER
- K061280 — V-2200 INFANT INCUBATOR
- K040910 — INFANT INCUBATOR, MODEL CHS-I1000
- K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K031387 — ISOLETTE INFANT INCUBATOR, MODEL C2000E
- K021809 — V-2100G ADVANCED INFANT INCUBATOR
- K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K010222 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K003067 — CALEO
- K001242 — ISOLETTE INFANT INCUBATOR, MODEL C2HS
- K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700
- K993407 — OHMEDA MEDICAL OMNIBED
- K993712 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K980886 — BABYTHERM 8000 LDR
- K974349 — OHMEDA-OHIO CARE PLUS INCUBATOR
- K954204 — DRAGER INCUBATOR 8000 IC
- K962806 — OHMEDA-OHIO CAE PLUS INCUBATOR
- K960980 — ISOLETTE INFANT INCUBATOR
- K943360 — OHIO CARE PLUS INCUBATOR
- K940975 — C450/C400 INFANT INCUBATORS
- K924324 — K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
- K922618 — BOWRON
- K920049 — MEDIX PC-305 NEONATAL INCUBATOR
- K924297 — DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER
- K924170 — ISOLETTE INCUBATOR HUMIDITY METER
- K912000 — TYPE INTERFACE 9271/1 INCUBATOR/WARMER
- K915752 — FIRST TOUCH/VILEDON NON-WOVEN FILTER
- K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR
- K914487 — OHIO CARE PLUS INCUBATOR
- K913394 — INCUBATOR 8000 IC
- K914134 — INCUBATOR 8000 SC
- K913291 — MODEL C386 ISOLETTE(R) INFANT INCUBATOR
- K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
- K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
- K913154 — OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
- K901157 — MP4, MP4SI, IT4 INCUBATORS
- K903378 — MODEL C286 ISOLETTE INFANT INCUBATOR
- K900752 — INCUBATOR 8000
- K901585 — OHMEDA - OHIO(R) CARE PLUS INCUBATOR
- K900735 — MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
- K895550 — K-1 INFANT TRANSPORT SYSTEM
- K895782 — NEONATAL INCUBATOR (ACCESSORY)
- K890476 — ADEL - MODEL 986 INFANT WARMER
- K881476 — PREEMICARE MODEL D1-X1, SERIES 3000
- K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
- K870222 — AMEDA AMECARE(R) NEONATAL INCUBATOR
- K870223 — AMEDA AMELETTE(R) NEONATAL INCUBATOR
- K871399 — OHIO(R) CARE PLUS INCUBATOR
- K840526 — AMETHERM
- K832418 — OHIO TEMPERATURE SIMULATOR
- K822656 — C-200 INFANT INCUBATOR
- K821896 — C-300 INFANT INCUBATOR
- K813239 — OXYGENAIRE NURING INCUBATOR
- K813238 — NEOCARE BABY-CONTROLLED INCUBATOR
- K810792 — NEOCARE TEMPERATURE MONITOR
- K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR
- K802639 — OHIO IC INCUBATOR
- K802640 — OHIO GC INCUBATOR
- K802126 — ISOLETTE INCUBATOR C-100
- K801461 — THERMA-SHIELD
- K781876 — ISOLETTE INCUBATOR
- K780472 — INFANT INCUBATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.