Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Incubator, Neonatal

FDA product code FMZ · 84 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5400
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-04-19 – 2026-07-28

FMZ 2026-07-28

Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)

Applicant Datex-Ohmeda, Inc.

K number K260326

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FMZ 2026-02-13

Babyleo TN500

Applicant Drägerwerk AG & Co. KGaA

K number K251619

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FMZ 2025-10-22

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

Applicant Datex-Ohmeda, Inc.

K number K251663

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FMZ 2025-08-14

mOm Essential Incubator (ME1)

Applicant Mom Incubators Limited

K number K243437

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FMZ 2022-03-02

Giraffe Incubator Carestation CS1

Applicant Datex Ohmeda, Inc.

K number K213553

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FMZ 2019-11-25

Infant Incubator

Applicant Ningbo David Medical Device Co., Ltd.

K number K190494

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FMZ 2019-02-22

Babyleo TN500

Applicant Dragerwerk AG & CO Kgaa

K number K182859

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FMZ 2018-11-21

Isolette 8000 Plus

Applicant Draeger Medical Systems, Inc.

K number K182977

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FMZ 2018-04-19

Isolette 8000 plus

Applicant Draeger Medical Sytems, Inc.

K number K172154

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FMZ 2017-06-23

Babyleo TN500

Applicant Draegerwerk AG & CO Kgaa

K number K162821

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FMZ 2016-03-17

Giraffe OmniBed Carestation CS1

Applicant Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company

K number K152814

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FMZ 2011-01-04

DUAL INCU I

Applicant Atom Medical Corporation

K number K102226

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FMZ 2010-12-29

INCU I

Applicant Atom Medical Corporation

K number K102279

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FMZ 2010-12-22

NEO-SERVO I

Applicant Atom Medical Corporation

K number K102710

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FMZ 2010-07-21

GIRAFFE OMNIBED

Applicant Ohmeda Medical

K number K101788

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FMZ 2010-07-21

GIRAFFE INCUBATOR

Applicant Ohmeda Medical

K number K101778

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FMZ 2008-05-23

TARRY MEDICAL TEMPERATURE PROBES

Applicant Tarry Medical Products, Inc.

K number K071977

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FMZ 2007-10-03

MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)

Applicant Datex-Ohmeda, Inc.

K number K072512

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FMZ 2007-09-21

MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX

Applicant Medix I.C.S.A.

K number K070291

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FMZ 2007-07-17

OHMEDA MEDICAL GIRAFFE OMNIBED

Applicant GE Healthcare

K number K071175

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FMZ 2006-09-28

V-2200 INFANT INCUBATOR

Applicant Atom Medical, Inc.

K number K061856

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FMZ 2006-08-04

VERSALET 7700 CARE CENTER

Applicant Draeger Medical Infant Care, Inc.

K number K053399

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FMZ 2006-06-27

V-2200 INFANT INCUBATOR

Applicant Neoforce Group, Inc.

K number K061280

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FMZ 2004-04-21

INFANT INCUBATOR, MODEL CHS-I1000

Applicant Choong Wae Medical Corp.

K number K040910

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FMZ 2004-04-16

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

Applicant Ohmeda Medical

K number K040068

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FMZ 2003-08-01

ISOLETTE INFANT INCUBATOR, MODEL C2000E

Applicant Hill-Rom Manufacturing, Inc.

K number K031387

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FMZ 2002-07-18

V-2100G ADVANCED INFANT INCUBATOR

Applicant Atom Medical Corp

K number K021809

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FMZ 2002-05-09

OHMEDA MEDICAL GIRAFFE INCUBATOR

Applicant Ohmeda Medical

K number K020547

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FMZ 2002-05-09

OHMEDA MEDICAL GIRAFFE OMNIBED

Applicant Ohmeda Medical

K number K020543

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FMZ 2001-03-21

OHMEDA MEDICAL GIRAFFE INCUBATOR

Applicant Ohmeda Medical

K number K010222

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FMZ 2000-12-13

CALEO

Applicant Drager Medizintechnik GmbH

K number K003067

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FMZ 2000-07-13

ISOLETTE INFANT INCUBATOR, MODEL C2HS

Applicant Hill-Rom Air-Shields

K number K001242

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FMZ 2000-02-03

VERSALET 7700 CARE CENTER, MODEL # 7700

Applicant Hill-Rom Air-Shields

K number K993051

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FMZ 2000-01-05

OHMEDA MEDICAL OMNIBED

Applicant Ohmeda Medical

K number K993407

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FMZ 1999-11-09

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

Applicant Ohmeda Medical

K number K993712

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FMZ 1998-05-29

BABYTHERM 8000 LDR

Applicant Draeger Medical, Inc.

K number K980886

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FMZ 1998-02-12

OHMEDA-OHIO CARE PLUS INCUBATOR

Applicant Ohmeda Medical

K number K974349

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FMZ 1997-04-25

DRAGER INCUBATOR 8000 IC

Applicant Drager, Inc.

K number K954204

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FMZ 1996-09-20

OHMEDA-OHIO CAE PLUS INCUBATOR

Applicant Ohmeda Medical

K number K962806

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FMZ 1996-07-30

ISOLETTE INFANT INCUBATOR

Applicant Air-Shields, Inc.

K number K960980

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FMZ 1994-09-29

OHIO CARE PLUS INCUBATOR

Applicant Ohmeda Medical

K number K943360

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FMZ 1994-06-23

C450/C400 INFANT INCUBATORS

Applicant Air-Shields, Inc.

K number K940975

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FMZ 1993-11-12

K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE

Applicant K-1 Medical Products, Inc.

K number K924324

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FMZ 1993-08-19

BOWRON

Applicant G.L. Bowron & Co. , Ltd.

K number K922618

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FMZ 1993-05-21

MEDIX PC-305 NEONATAL INCUBATOR

Applicant Medix I.C.S.A.

K number K920049

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FMZ 1993-03-18

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER

Applicant Air-Shields Vickers, Inc.

K number K924297

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FMZ 1993-02-05

ISOLETTE INCUBATOR HUMIDITY METER

Applicant Air-Shields, Inc.

K number K924170

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FMZ 1992-09-21

TYPE INTERFACE 9271/1 INCUBATOR/WARMER

Applicant S & W Medico Teknik

K number K912000

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FMZ 1992-09-17

FIRST TOUCH/VILEDON NON-WOVEN FILTER

Applicant First Touch Disposables, Inc.

K number K915752

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FMZ 1992-03-13

MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR

Applicant Air-Shields, Inc.

K number K914864

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FMZ 1991-12-18

OHIO CARE PLUS INCUBATOR

Applicant Ohmeda Medical

K number K914487

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FMZ 1991-11-22

INCUBATOR 8000 SC

Applicant National Draeger, Inc.

K number K914134

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FMZ 1991-11-22

INCUBATOR 8000 IC

Applicant Dragerwerk AG

K number K913394

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FMZ 1991-11-13

MODEL C386 ISOLETTE(R) INFANT INCUBATOR

Applicant Air-Shields, Inc.

K number K913291

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FMZ 1991-11-05

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM

Applicant Air-Shields Vickers, Inc.

K number K912909

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FMZ 1991-10-30

C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM

Applicant Air-Shields Vickers, Inc.

K number K912910

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FMZ 1991-09-13

OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION

Applicant Ohmeda Medical

K number K913154

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FMZ 1991-03-27

MP4, MP4SI, IT4 INCUBATORS

Applicant Mediprema

K number K901157

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FMZ 1990-10-15

MODEL C286 ISOLETTE INFANT INCUBATOR

Applicant Air-Shields Vickers, Inc.

K number K903378

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FMZ 1990-08-02

INCUBATOR 8000

Applicant Dragerwerk AG

K number K900752

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FMZ 1990-06-22

OHMEDA - OHIO(R) CARE PLUS INCUBATOR

Applicant Ohmeda Medical

K number K901585

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FMZ 1990-05-02

MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR

Applicant Preemicare Corp.

K number K900735

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FMZ 1989-12-07

NEONATAL INCUBATOR (ACCESSORY)

Applicant Air-Shields Vickers, Inc.

K number K895782

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FMZ 1989-12-07

K-1 INFANT TRANSPORT SYSTEM

Applicant K-1 Medical Products, Inc.

K number K895550

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FMZ 1989-06-16

ADEL - MODEL 986 INFANT WARMER

Applicant Adel Medical , Ltd.

K number K890476

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FMZ 1988-12-08

PREEMICARE MODEL D1-X1, SERIES 3000

Applicant Preemicare Corp.

K number K881476

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FMZ 1988-11-14

C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR

Applicant Air-Shields Vickers, Inc.

K number K884086

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FMZ 1987-06-10

AMEDA AMELETTE(R) NEONATAL INCUBATOR

Applicant Hollister, Inc.

K number K870223

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FMZ 1987-06-10

AMEDA AMECARE(R) NEONATAL INCUBATOR

Applicant Hollister, Inc.

K number K870222

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FMZ 1987-06-05

OHIO(R) CARE PLUS INCUBATOR

Applicant Ohmeda Medical

K number K871399

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FMZ 1984-04-30

AMETHERM

Applicant Egnell, Inc.

K number K840526

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FMZ 1983-09-12

OHIO TEMPERATURE SIMULATOR

Applicant Airco/Ohio Medical Products

K number K832418

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FMZ 1982-10-18

C-200 INFANT INCUBATOR

Applicant Narco Scientific

K number K822656

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FMZ 1982-07-28

C-300 INFANT INCUBATOR

Applicant Narco Scientific

K number K821896

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FMZ 1982-01-28

OXYGENAIRE NURING INCUBATOR

Applicant Vickers America Medical Corp.

K number K813239

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FMZ 1982-01-22

NEOCARE BABY-CONTROLLED INCUBATOR

Applicant Vickers America Medical Corp.

K number K813238

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FMZ 1981-04-29

NEOCARE TEMPERATURE MONITOR

Applicant Vickers America Medical Corp.

K number K810792

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FMZ 1981-03-11

140 NEOCARE AIR CONTROLLED INCUBATOR

Applicant Vickers America Medical Corp.

K number K810067

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FMZ 1980-11-12

OHIO GC INCUBATOR

Applicant Ohio Medical Products

K number K802640

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FMZ 1980-11-12

OHIO IC INCUBATOR

Applicant Ohio Medical Products

K number K802639

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FMZ 1980-09-26

ISOLETTE INCUBATOR C-100

Applicant Narco Air-Shields

K number K802126

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FMZ 1980-07-28

THERMA-SHIELD

Applicant Olympic Medical Corp.

K number K801461

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FMZ 1978-12-07

ISOLETTE INCUBATOR

Applicant Air-Shields, Inc.

K number K781876

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FMZ 1978-04-19

INFANT INCUBATOR

Applicant Air-Shields, Inc.

K number K780472

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