Panels › Anesthesiology › Product code CBK · Class 2
Ventilator, Continuous, Facility Use
Regulation 868.5895
4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2007 | K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 Pulmonetic Systems, Inc. | CBK |
| Jul 30, 2007 | K071212 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| May 17, 2007 | K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED Sleepnet Corporation | CBK |
| Feb 15, 2007 | K063650 | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 Puritan Bennett Corp. | CBK |
| Feb 15, 2007 | K063404 | SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 Maquet Critical Care AB | CBK |
| Feb 7, 2007 | K062793 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION Maquet Critical Care AB | CBK |
| Dec 8, 2006 | K062710 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Oct 31, 2006 | K062267 | OXYLOG 3000 Drager Medical B.V. | CBK |
| Sep 20, 2006 | K062093 | AVEA VENTILATOR Viasys Respiratory Care, Inc. | CBK |
| Aug 17, 2006 | K062019 | RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD Innomed Technologies, Inc./Respcare, Inc. | CBK |
| Jul 28, 2006 | K061094 | NEWPORT E500 WAVE VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Jul 17, 2006 | K061090 | GALILEO GOLD ASV Hamilton Medical AG, CH | CBK |
| Jun 29, 2006 | K061627 | MODIFICATION TO I VENT 201 Versamed Medical Systems, Inc. | CBK |
| Jun 14, 2006 | K060705 | CARINA HOME Draeger Medical B.V. | CBK |
| Jun 5, 2006 | K060862 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| May 25, 2006 | K060647 | LTV 1200 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| May 4, 2006 | K060549 | AUTOMOBILE LIGHTER POWER CORD Pulmonetic Systems, Inc. | CBK |
| Apr 4, 2006 | K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION Puritan Bennett Corp. | CBK |
| Jan 27, 2006 | K053270 | IVENT 201 Versamed Medical Systems, Inc. | CBK |
| Jan 10, 2006 | K053502 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Jan 6, 2006 | K052863 | RAPHAEL COLOR Hamilton Medical AG, CH | CBK |
| Sep 27, 2005 | K051895 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Sep 23, 2005 | K052554 | MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR Versamed Medical Systems, Inc. | CBK |
| Sep 23, 2005 | K051222 | AV-S ANAESTHESIA VENTILATOR Penlon Limited, GB | CBK |
| Jul 29, 2005 | K051767 | LTV 1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Jul 12, 2005 | K051550 | INSPIRATION VENTILATOR SYSTEM eVent Medical, Ltd., IE | CBK |
| Jul 12, 2005 | K051263 | EVITAXL WITH OPTION SMARTCARE Drager Medical AG & Co. Kgaa | CBK |
| Jul 8, 2005 | K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Jun 21, 2005 | K050860 | GE DATEX-OHMEDA CENTIVA/5 VENTILATOR Datex-Ohmeda, Inc. | CBK |
| Mar 25, 2005 | K050597 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Dec 20, 2004 | K043085 | MODIFICATION TO: PNEUTON VENTILATOR Airon Corporation | CBK |
| Nov 17, 2004 | K042468 | IVENT 201 PORTABLE VENTILATOR Versamed Medical Systems, Inc. | CBK |
| Oct 27, 2004 | K040574 | GALILEO GOLD Hamilton Medical, Inc. | CBK |
| Oct 26, 2004 | K041775 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Sep 22, 2004 | K032922 | CLARISSA INFANT NCPAP CANNULA Airways Ltd., Inc. | CBK |
| Sep 20, 2004 | K041524 | GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM Datex-Ohmeda, Inc. | CBK |
| Jul 29, 2004 | K041223 | MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB | CBK |
| Jun 18, 2004 | K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Jun 3, 2004 | K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS Pulmonetic Systems, Inc. | CBK |
| Jun 2, 2004 | K040642 | LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA Draeget Medical AG & Co. Kgaa | CBK |
| Apr 29, 2004 | K040540 | MODIFICATION TO LTV 1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Mar 17, 2004 | K032451 | BIRD TBIRD VELA VENTILATOR Bird Products Corp. | CBK |
| Feb 20, 2004 | K040221 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB | CBK |
| Jan 23, 2004 | K030780 | NEWPORT E500 WAVE VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Jan 21, 2004 | K034040 | ESPRIT VENTILATOR, MODEL V1000 Respironics, Inc. | CBK |
| Jan 16, 2004 | K030341 | MODIFICATION TO INSPIRATION VENTILATOR SYSTEM eVent Medical, Ltd., IE | CBK |
| Oct 22, 2003 | K022679 | RAPHAEL Hamilton Medical AG | CBK |
| Oct 16, 2003 | K032226 | LTV-1000 VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Oct 7, 2003 | K023366 | DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS Datex-Ohmeda, Inc. | CBK |
| Jun 3, 2003 | K024344 | PNEUTON VENTILATOR Airon Corporation | CBK |
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