Ohmeda Medical
FDA Regulatory Profile
Ohmeda Medical appears in FDA public data with 13 recalls, 120 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0041-2020, Class II) was initiated on October 5, 2018. Its most recent 510(k) clearance was granted on February 5, 2013.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 120
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0041-2020 | Class II | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant w | October 5, 2018 |
| Z-1181-2018 | Class II | Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an | December 1, 2017 |
| Z-1509-2017 | Class II | Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incub | November 18, 2016 |
| Z-1506-2017 | Class II | Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrar | November 18, 2016 |
| Z-1502-2017 | Class II | Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a contro | November 18, 2016 |
| Z-1503-2017 | Class II | Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy Syst | November 18, 2016 |
| Z-1507-2017 | Class II | Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Un | November 18, 2016 |
| Z-1501-2017 | Class II | Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation dur | November 18, 2016 |
| Z-1511-2017 | Class II | IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to n | November 18, 2016 |
| Z-1510-2017 | Class II | CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environm | November 18, 2016 |
| Z-1504-2017 | Class II | Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator | November 18, 2016 |
| Z-1508-2017 | Class II | Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers | November 18, 2016 |
| Z-1505-2017 | Class II | Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. In | November 18, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123309 | GIRAFFE AND PANDA WARMERS | February 5, 2013 |
| K101778 | GIRAFFE INCUBATOR | July 21, 2010 |
| K101788 | GIRAFFE OMNIBED | July 21, 2010 |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | April 16, 2009 |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | August 27, 2007 |
| K070377 | GIRAFFE AND PANDA WARMER | July 11, 2007 |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | April 20, 2007 |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | April 20, 2007 |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | April 16, 2004 |
| K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR | May 9, 2002 |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 |
| K010388 | SONDREX P.A.L. SYSTEM | December 11, 2001 |
| K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM | July 19, 2001 |
| K010222 | OHMEDA MEDICAL GIRAFFE INCUBATOR | March 21, 2001 |
| DEN000001 | OHMEDA INOVENT DELIVERY SYSTEM | January 11, 2000 |
| K993407 | OHMEDA MEDICAL OMNIBED | January 5, 2000 |
| K993712 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | November 9, 1999 |
| K973896 | OHMEDA EXCEL 3000 ANESTHESIA SYSTEM | April 21, 1998 |
| K974349 | OHMEDA-OHIO CARE PLUS INCUBATOR | February 12, 1998 |
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS | January 13, 1998 |