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 |
|---|---|---|---|
| Jan 21, 2011 | K102775 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Dec 22, 2010 | K102054 | V200 VENTILATOR Respironics California, Inc. | CBK |
| Dec 7, 2010 | K101401 | NEUMOVENT GRAPHNET MODEL 3179L1V Tecme S.A. | CBK |
| Sep 16, 2010 | K101129 | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK Respironics, Inc. | CBK |
| Sep 8, 2010 | K101803 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc. | CBK |
| Aug 20, 2010 | K100753 | FLIGHT 60 VENTILATOR, MODEL F-60 Flight Medical , Ltd. | CBK |
| May 12, 2010 | K093905 | TRILOGY 202 VENTILATOR Respironics, Inc. | CBK |
| May 11, 2010 | K093094 | VELA VENTILATOR Cardinal Health 207, Inc. | CBK |
| May 3, 2010 | K093886 | ENGSTROM CARESTATION, ENGSTROM PRO Datex-Ohmeda Inc., A Division of Instrumentarium C | CBK |
| Apr 5, 2010 | K093632 | INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE Drager Medical AG & Co. Kgaa | CBK |
| Mar 30, 2010 | K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE Draegerwerk AG & CO Kgaa, DE | CBK |
| Mar 11, 2010 | K092847 | 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION Covidien, Formerly Nellcor Puritan Bennett, Inc. | CBK |
| Mar 4, 2010 | K092148 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Jan 29, 2010 | K093416 | TRILOGY 200 VENTILATOR Respironics, Inc. | CBK |
| Jan 21, 2010 | K092263 | ENDURAVENT-5 VENTILATOR Providence Global Medical, Inc. | CBK |
| Dec 18, 2009 | K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | CBK |
| Dec 17, 2009 | K092264 | ATLANTIS HYPERBARIC CHAMBER VENTILATOR Providence Global Medical, Inc. | CBK |
| Nov 23, 2009 | K092135 | MODIFICATION TO IVENT 101 Versamed Medical Systems , Ltd. | CBK |
| Nov 18, 2009 | K090888 | NEWPORT HT70 FAMILY OF VENTILATORS Newport Medical Instruments, Inc. | CBK |
| Aug 13, 2009 | K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ Impact Instrumentation, Inc. | CBK |
| Jun 15, 2009 | K090468 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Apr 2, 2009 | K083693 | PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 Covidien, Formerly Nellcor Puritan Bennett, Inc. | CBK |
| Mar 18, 2009 | K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR Pulmonetic Systems, Inc. | CBK |
| Mar 16, 2009 | K081845 | IVENT101 Versamed Medical Systems, Inc. | CBK |
| Mar 13, 2009 | K083526 | TRILOGY 100 VENTILATOR Respironics Inc., Sleep & Home Respiratory Group | CBK |
| Mar 4, 2009 | K083122 | HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 Fisher & Paykel Healthcare, Ltd., NZ | CBK |
| Jan 2, 2009 | K082351 | NEPTUNE HYPERBARIC VENTILATOR Level-5, Inc. | CBK |
| Dec 29, 2008 | K083050 | EVITE XL Draeger Medical AG & Co. KG | CBK |
| Dec 16, 2008 | K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM Newport Medical Instruments, Inc. | CBK |
| Dec 10, 2008 | K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV Impact Instrumentation, Inc. | CBK |
| Nov 26, 2008 | K082600 | OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) Draeger Medical B.V. | CBK |
| Oct 31, 2008 | K082966 | PB 540 VENTILATOR Covidien, Formerly Nellcor Puritan Bennett, Inc. | CBK |
| Oct 15, 2008 | K072926 | HELONTIX VENT Linde Gas Therapeutics, SE | CBK |
| Oct 9, 2008 | K081670 | THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK Cardinal Health 207, Inc. | CBK |
| Oct 3, 2008 | K081842 | ENGSTROM CARESTATION, ENGSTROM PRO Datex-Ohmeda, Inc. | CBK |
| Sep 25, 2008 | K081521 | MODIFICATION TO HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Sep 22, 2008 | K081743 | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS Draeger Medical AG & Co. KG, DE | CBK |
| Aug 13, 2008 | K081837 | AVEA VENTILATOR Cardinal Health 207, Inc. | CBK |
| Jun 24, 2008 | K080181 | MODIFICATION TO GALILEO GOLD Hamilton Medical AG, CH | CBK |
| Jun 9, 2008 | K073179 | SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 Maquet Critical Care AB | CBK |
| May 30, 2008 | K073694 | IVENT 2001 MRI CONDITIONAL Versamed Medical Systems, Inc. | CBK |
| Apr 7, 2008 | K072885 | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 Draeger Medical AG & Co. KG | CBK |
| Feb 6, 2008 | K072412 | OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 Drager Medical AG & Co. Kgaa | CBK |
| Jan 25, 2008 | K073069 | MODIFICATION TO AVEA VENTILATOR Viasys Respiratory Care, Inc. | CBK |
| Jan 4, 2008 | K072590 | INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM Event Medical, Inc. | CBK |
| Dec 18, 2007 | K072588 | PERFORMAX SE TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | CBK |
| Dec 13, 2007 | K070899 | PURITAN BENNETT LEGENDAIR XL2 Nellcor Puritan Bennett | CBK |
| Dec 12, 2007 | K072450 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Nov 26, 2007 | K070513 | HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Oct 18, 2007 | K071194 | RAPHAEL COLOR ASV VENTILATOR Hamilton Medical AG, CH | CBK |
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