Company ยท US
Ohmeda Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2013. Name variants (Inc, Corp, punctuation) are merged.
120510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMZ | Incubator, Neonatal | 20 |
| BSZ | Gas-Machine, Anesthesia | 17 |
| FMT | Warmer, Infant Radiant | 15 |
| CBK | Ventilator, Continuous, Facility Use | 10 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 |
| DQA | Oximeter | 5 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 4 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 4 |
| FMG | Stopcock, I.V. Set | 4 |
| LBI | Unit, Neonatal Phototherapy | 4 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 |
| BSF | Absorber, Carbon-Dioxide | 2 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 |
| BTI | Compressor, Air, Portable | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 2013 | K123309 | GIRAFFE AND PANDA WARMERS Ohmeda Medical | FMT |
| Jul 21, 2010 | K101788 | GIRAFFE OMNIBED Ohmeda Medical | FMZ |
| Jul 21, 2010 | K101778 | GIRAFFE INCUBATOR Ohmeda Medical | FMZ |
| Apr 16, 2009 | K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER Ohmeda Medical | FMT |
| Aug 27, 2007 | K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) Ohmeda Medical | FMT |
| Jul 11, 2007 | K070377 | GIRAFFE AND PANDA WARMER Ohmeda Medical | FMT |
| Apr 20, 2007 | K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM Ohmeda Medical | BTM |
| Apr 20, 2007 | K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM Ohmeda Medical | BTL |
| Apr 16, 2004 | K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM Ohmeda Medical | FMZ |
| May 9, 2002 | K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR Ohmeda Medical | FMZ |
| May 9, 2002 | K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED Ohmeda Medical | FMZ |
| Dec 11, 2001 | K010388 | SONDREX P.A.L. SYSTEM Ohmeda Medical | HCC |
| Jul 19, 2001 | K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM Ohmeda Medical | LBI |
| Mar 21, 2001 | K010222 | OHMEDA MEDICAL GIRAFFE INCUBATOR Ohmeda Medical | FMZ |
| Jan 11, 2000 | DEN000001 | OHMEDA INOVENT DELIVERY SYSTEM Ohmeda Medical | MRN |
| Jan 5, 2000 | K993407 | OHMEDA MEDICAL OMNIBED Ohmeda Medical | FMZ |
| Nov 9, 1999 | K993712 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM Ohmeda Medical | FMZ |
| Apr 21, 1998 | K973896 | OHMEDA EXCEL 3000 ANESTHESIA SYSTEM Ohmeda Medical | BSZ |
| Feb 12, 1998 | K974349 | OHMEDA-OHIO CARE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Jan 13, 1998 | K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS Ohmeda Medical | FMG |
| Jan 2, 1998 | K974374 | SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV Ohmeda Medical | JKA |
| Dec 2, 1997 | K971243 | OHMEDA INFANT RESUSCITATION SYSTEM Ohmeda Medical | BTM |
| Jun 17, 1997 | K965041 | OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM Ohmeda Medical | BSZ |
| Jan 17, 1997 | K962648 | OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR Ohmeda Medical | CBQ |
| Oct 10, 1996 | K962127 | OHMEDA 3800 PULSE OXIMETER Ohmeda Medical | DQA |
| Oct 8, 1996 | K946127 | OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM Ohmeda Medical | BSZ |
| Oct 1, 1996 | K963058 | INFANT WARMER SYSTEM Ohmeda Medical | FMT |
| Sep 27, 1996 | K960964 | OHMEDA 7900 ANESTHESIA VENTILATOR Ohmeda Medical | CBK |
| Sep 20, 1996 | K962806 | OHMEDA-OHIO CAE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Jul 7, 1995 | K944052 | RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR Ohmeda Medical | CCK |
| Mar 30, 1995 | K942091 | OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE Ohmeda Medical | CAD |
| Oct 14, 1994 | K935090 | CUFF-CATH Ohmeda Medical | FOZ |
| Sep 29, 1994 | K943360 | OHIO CARE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Sep 29, 1994 | K931304 | OHMEDA HAND HELD OXIMETER Ohmeda Medical | DQA |
| Aug 1, 1994 | K935782 | DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES Ohmeda Medical | DXN |
| Jul 6, 1994 | K941428 | EXACTA PERCUTANEOUS INTRODUCER SHEATH Ohmeda Medical | DYB |
| Mar 25, 1994 | K936182 | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT Ohmeda Medical | KRB |
| Mar 15, 1994 | K935274 | DIPRIVAN LUER CONNECTOR Ohmeda Medical | LHI |
| Oct 19, 1993 | K931439 | OHMEDA MODEL 5330 ANESTHETIC MONITOR Ohmeda Medical | CBQ |
| May 26, 1993 | K921742 | OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY Ohmeda Medical | BSZ |
| May 13, 1993 | K930866 | RASCAL II Ohmeda Medical | CCK |
| Apr 23, 1993 | K921766 | OHIO INFANT WARMER SYSTEM Ohmeda Medical | FMT |
| Oct 13, 1992 | K920622 | RASCAL II Ohmeda Medical | CCK |
| Oct 6, 1992 | K913593 | OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER Ohmeda Medical | CAD |
| Aug 31, 1992 | K920590 | OHMEDA MODEL 5250 RGM MONITOR Ohmeda Medical | CCK |
| Jul 28, 1992 | K910571 | BILIBLANKET LIGHT METER Ohmeda Medical | LBI |
| Mar 19, 1992 | K910929 | OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V. Ohmeda Medical | DSI |
| Dec 18, 1991 | K914487 | OHIO CARE PLUS INCUBATOR Ohmeda Medical | FMZ |
| Sep 13, 1991 | K913154 | OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION Ohmeda Medical | FMZ |
| Aug 2, 1991 | K911193 | OHMEDA MODEL 4700 OXICAP Ohmeda Medical | CCK |
Newest 50 of 120.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | Ohmeda Medical Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to Terminated |
FMZ | K993407 |
| Dec 1, 2017 | Ohmeda Medical Rotating IV Pole
Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipmen Terminated |
FOX | None listed |
| Nov 18, 2016 | Ohmeda Medical IWS
Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat t Terminated |
FMT | K963058 |
| Nov 18, 2016 | Ohmeda Medical CarePlus Incubator
Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for shor Terminated |
FMZ | K974349 |
| Nov 18, 2016 | Ohmeda Medical Giraffe OmniBed
Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled m Terminated |
FMZ | K993407 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Bedded Warmer, Panda Warmer
Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on Terminated |
FMT | K090697 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Bedded Warmer, Panda Warmer
Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to Terminated |
FMT | K072157 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Bedded Warmer, Panda Warmer
Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physio Terminated |
FMT | K070377 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Incubator
Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on t Terminated |
FMZ | K020547 |
| Nov 18, 2016 | Ohmeda Medical Giraffe OmniBed
Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition f Terminated |
FMT | K020543 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Spot PT
Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundic Terminated |
LBI | K011549 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Incubator
The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators p Terminated |
FMZ | K010222 |
| Nov 18, 2016 | Ohmeda Medical Giraffe Exam Light
The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the Terminated |
KZF | None listed |