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 |
|---|---|---|---|
| Jun 18, 1986 | K862025 | ENGSTROM ERICA II RESPIRATOR Gambro, Inc. | CBK |
| May 6, 1986 | K861488 | COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM Puritan Bennett Corp. | CBK |
| May 6, 1986 | K861432 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| May 6, 1986 | K860438 | NEWPORT VENTILATOR MODEL E-100 Newport Medical Instruments, Inc. | CBK |
| Apr 7, 1986 | K860675 | COMPANION 2800 VOLUME VENTILATOR REMOT ALARM Puritan Bennett Corp. | CBK |
| Apr 4, 1986 | K853501 | HONEYWELL ELECTRONIC VENTILATOR EV-A Honeywell, Inc. | CBK |
| Feb 14, 1986 | K854070 | MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM Puritan Bennett Corp. | CBK |
| Jan 21, 1986 | K854300 | 7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY Puritan Bennett Corp. | CBK |
| Dec 3, 1985 | K853760 | ADULT VENTILATOR TESTER VT-1 Bio-Tek Instruments, Inc. | CBK |
| Oct 10, 1985 | K852771 | PC INTERFACE Siemens Elema AB | CBK |
| Aug 15, 1985 | K853300 | HEALTHDYNE IMPLUSE VENTILATOR Healthdyne, Inc. | CBK |
| Jul 15, 1985 | K851509 | OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR Ohmeda Medical | CBK |
| Apr 25, 1985 | K850374 | CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO Siemens Elema AB | CBK |
| Jan 18, 1985 | K844179 | LP-5 Life Products, Inc. | CBK |
| Jan 18, 1985 | K842122 | 4A Life Products, Inc. | CBK |
| Jan 16, 1985 | K844081 | LP4 VENTILATOR Life Products, Inc. | CBK |
| Dec 28, 1984 | K844912 | SERVO VENTILATOR 900D SIEMENS-ELEMA AB Siemens Elema AB | CBK |
| Dec 27, 1984 | K844350 | NEWPORT VENTILATOR MODEL E-100 Newport Medical Instruments, Inc. | CBK |
| Nov 29, 1984 | K844590 | POWER PACK 160 SIEMENS-ELEMA AB Siemens Elema AB | CBK |
| Nov 1, 1984 | K843424 | MICROPROCESSOR 7200A VENTILATOR Puritan Bennett Corp. | CBK |
| Oct 4, 1984 | K843737 | PNEUPAC INSTANT ACTION VENTILATOR/RESUS Pneupac , Ltd. | CBK |
| Aug 29, 1984 | K842876 | PORTABLE LIFECARE VENTILATOR PLV-102 Lifecare Services, Inc. | CBK |
| Jul 26, 1984 | K842688 | BEAR JET-150 VENTILATOR Bear Medical Systems, Inc. | CBK |
| Jun 26, 1984 | K842363 | PENLON ANESTHESIA VENTILATOR SERIES 300 Bear Medical Systems, Inc. | CBK |
| Jun 26, 1984 | K842362 | PENLON TRANSPORT VENTILATOR SERIES 350 Bear Medical Systems, Inc. | CBK |
| Jun 5, 1984 | K841818 | IMPULSE VENTILATOR Healthdyne, Inc. | CBK |
| May 23, 1984 | K841529 | SIEMENS-ELEMA VENTILATOR 900C Siemens Elema AB | CBK |
| May 23, 1984 | K841279 | BEAR 33 Bear Medical Systems, Inc. | CBK |
| May 21, 1984 | K841393 | AB MANUAL VENTILATION ACCESS. 900C Siemens Elema AB | CBK |
| May 16, 1984 | K841757 | 7200 MICROPROCESSOR VENTILATOR Puritan Bennett Corp. | CBK |
| Apr 30, 1984 | K840865 | INFANT STAR VENTILATOR Infrasonics Corp. | CBK |
| Apr 6, 1984 | K840119 | CONTINUOUS VENTILATOR Bear Medical Systems, Inc. | CBK |
| Mar 5, 1984 | K833982 | MODEL IV 100B-DA INFANT VENTILATOR Sechrist Industries, Inc. | CBK |
| Feb 23, 1984 | K840345 | IMPULSE VENTILATOR Healthdyne, Inc. | CBK |
| Dec 27, 1983 | K832508 | VOLUME VENTILATOR Sechrist Industries, Inc. | CBK |
| Dec 22, 1983 | K833786 | MICROPROCESSOR VENTILATOR 7200 Puritan Bennett Corp. | CBK |
| Nov 14, 1983 | K832700 | PNEU PAC VENTILATOR/RESUSCITATORS Pneupac , Ltd. | CBK |
| Nov 3, 1983 | K831877 | ARF 850 E W.E. Leder Enterprises, Inc. | CBK |
| Oct 20, 1983 | K832467 | PORTABLE LIFECARE VENTILATOR PLV-100 Lifecare Services, Inc. | CBK |
| Sep 29, 1983 | K822835 | PZ-800 VOLUME VENTILATOR Narco Scientific | CBK |
| Sep 15, 1983 | K830488 | VENTILATOR #1 Ohio Medical Products | CBK |
| Feb 9, 1983 | K830230 | PROGRAMMABLE VENTILATOR Bio-Med Devices, Inc. | CBK |
| Feb 7, 1983 | K823861 | ET-3 EMERGENCY TRANSPORT VENTILATOR Bio-Med Devices, Inc. | CBK |
| Dec 22, 1982 | K823858 | VOLUME VENTILATOR Puritan Bennett Corp. | CBK |
| Nov 16, 1982 | K822888 | OHIO CPU-1 INTENSIVE CARE VENTILATOR Ohio Medical Products | CBK |
| Nov 16, 1982 | K822635 | 225 S.I.M.V. VENTILATOR Monaghan Medical Corp. | CBK |
| Sep 21, 1982 | K822456 | OHIO V5A ANESTHESIA VENTILATOR Airco/Ohio Medical Products | CBK |
| Aug 31, 1982 | K822113 | INSPIRAID VA-1 VENTILATOR Inspir Aid | CBK |
| Aug 27, 1982 | K822233 | ABT 4000 VENTILATOR Kontron Instruments, Inc. | CBK |
| Aug 19, 1982 | K822040 | POWERED EMERGENCY VENTILATOR Fraser Harlake, Inc. | CBK |
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