Ohmeda Medical

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
120
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0041-2020Class IIGiraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant wOctober 5, 2018
Z-1181-2018Class IIRotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an December 1, 2017
Z-1507-2017Class IIGiraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda UnNovember 18, 2016
Z-1505-2017Class IIGiraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. InNovember 18, 2016
Z-1511-2017Class IIIWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to nNovember 18, 2016
Z-1509-2017Class IIGiraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubNovember 18, 2016
Z-1506-2017Class IIGiraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrarNovember 18, 2016
Z-1502-2017Class IIGiraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controNovember 18, 2016
Z-1503-2017Class IIGiraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy SystNovember 18, 2016
Z-1504-2017Class IIGiraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubatorNovember 18, 2016
Z-1510-2017Class IICarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environmNovember 18, 2016
Z-1508-2017Class IIGiraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmersNovember 18, 2016
Z-1501-2017Class IIGiraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation durNovember 18, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K123309GIRAFFE AND PANDA WARMERSFebruary 5, 2013
K101778GIRAFFE INCUBATORJuly 21, 2010
K101788GIRAFFE OMNIBEDJuly 21, 2010
K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERApril 16, 2009
K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)August 27, 2007
K070377GIRAFFE AND PANDA WARMERJuly 11, 2007
K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMApril 20, 2007
K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMApril 20, 2007
K040068BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMApril 16, 2004
K020543OHMEDA MEDICAL GIRAFFE OMNIBEDMay 9, 2002
K020547OHMEDA MEDICAL GIRAFFE INCUBATORMay 9, 2002
K010388SONDREX P.A.L. SYSTEMDecember 11, 2001
K011549OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEMJuly 19, 2001
K010222OHMEDA MEDICAL GIRAFFE INCUBATORMarch 21, 2001
DEN000001OHMEDA INOVENT DELIVERY SYSTEMJanuary 11, 2000
K993407OHMEDA MEDICAL OMNIBEDJanuary 5, 2000
K993712BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMNovember 9, 1999
K973896OHMEDA EXCEL 3000 ANESTHESIA SYSTEMApril 21, 1998
K974349OHMEDA-OHIO CARE PLUS INCUBATORFebruary 12, 1998
K974083CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSJanuary 13, 1998