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 |
|---|---|---|---|
| Oct 13, 1989 | K895486 | BIRD (VDR) SINUSOIDAL PERCUSSIONATORS Percussionaire Corp. | CBK |
| Sep 26, 1989 | K894426 | LEONARDO INFORMATION SYSTEM Hamilton Medical, Inc. | CBK |
| Sep 22, 1989 | K894316 | AMADEUS VENTILATOR Hamilton Medical, Inc. | CBK |
| Sep 22, 1989 | K893786 | SERVO ANESTHESIA CIRCLE 985 Siemens Life Support Systems | CBK |
| Sep 14, 1989 | K884832 | PERCUSSIONAIRE RESPIRATORS (MULTIPLE) Percussionaire Corp. | CBK |
| Aug 4, 1989 | K893043 | PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR Puritan Bennett Corp. | CBK |
| Jun 23, 1989 | K883809 | NEWPORT VENTILATOR MODEL E150 Newport Medical Instruments, Inc. | CBK |
| Jun 12, 1989 | K884793 | ADVENT VENTILATOR Ohmeda Medical | CBK |
| Jun 8, 1989 | K890921 | DATA EXCHANGE SYSTEM, MODEL 24 Siemens Life Support Systems | CBK |
| Jun 8, 1989 | K884521 | STAR SYNC Infrasonics Corp. | CBK |
| Jun 8, 1989 | K883865 | EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 Acutronic Medical Systems AG, CH | CBK |
| Jun 6, 1989 | K883159 | OHMEDA 7800 ANESTHESIA VENTILATOR Ohmeda Medical | CBK |
| Jan 17, 1989 | K884520 | SERVO VENTILATOR 900E Siemens-Elema Ventilation Systems | CBK |
| Sep 30, 1988 | K882764 | BEAR EVC-100 CONTROLLER Bear Medical Systems, Inc. | CBK |
| Sep 6, 1988 | K880923 | PATIENT VENTILATOR ISOLATOR Dryden Corp. | CBK |
| Aug 4, 1988 | K881335 | BEAR 3 VENTILATOR Bear Medical Systems, Inc. | CBK |
| Jul 8, 1988 | K872466 | ADULT STAR Infrasonics Corp. | CBK |
| Jun 16, 1988 | K881482 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| Jun 14, 1988 | K881420 | OMNI-VENT, SERIES D/MRI Stein-Gates Medical Equipment, Inc. | CBK |
| May 31, 1988 | K873151 | MODEL 7200A, PRESSURE VENTILATION OPTION Puritan Bennett Corp. | CBK |
| Apr 21, 1988 | K871792 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| Apr 14, 1988 | K880721 | 6400ST INTERFACE MODULE-RS232 Bird Products Corp. | CBK |
| Apr 14, 1988 | K880054 | CPU 1100 VENTILATOR Ohmeda Medical | CBK |
| Mar 23, 1988 | K872113 | OMNI-VENT, SERIES D Stein-Gates Medical Equipment, Inc. | CBK |
| Mar 3, 1988 | K872482 | GAMBRO-ENGSTROM ERICA IV RESPIRATOR Gambro, Inc. | CBK |
| Jan 22, 1988 | K873215 | COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION Puritan Bennett Corp. | CBK |
| Jan 19, 1988 | K870861 | UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR Impact Instrumentation, Inc. | CBK |
| Jan 11, 1988 | K874415 | PRESSURE LIMIT CONTROL Draeger Medical, Inc. | CBK |
| Dec 11, 1987 | K874371 | ASCENDING VENTILATOR BELLOWS Draeger Medical, Inc. | CBK |
| Oct 8, 1987 | K873549 | PEDIATRIC BELLOWS Draeger Medical, Inc. | CBK |
| Sep 28, 1987 | K863155 | UNIVERSAL JET VENTILATOR MODEL AMS-1000 Acutronic Medical Systems AG, CH | CBK |
| Jul 21, 1987 | K871354 | SERVO VENTILATOR 900 C/D Siemens Elema AB | CBK |
| Jun 15, 1987 | K871985 | BEAR JET VENTILATOR FOR USE DURING (ESWL) Bear Medical Systems, Inc. | CBK |
| May 29, 1987 | K871433 | PPG BIOMEDICAL VENTILATOR MODEL AV 400 Ppg Industries, Inc. | CBK |
| May 7, 1987 | K871448 | MODEL 105 VENTILATOR Developmed Corp. | CBK |
| May 7, 1987 | K871398 | CPU-1 INTENSIVE CARE VENTILATOR Ohmeda Medical | CBK |
| May 6, 1987 | K871009 | MVP-1500 CONTINUOUS VENTILATOR Medimex, Inc. | CBK |
| Mar 9, 1987 | K870275 | COMPANION 2800 PORTABLE VOLUME VENTILATOR Puritan Bennett Corp. | CBK |
| Feb 10, 1987 | K863228 | BIRD 6400ST VOLUME VENTILATOR Bird Products Corp. | CBK |
| Jan 12, 1987 | K864431 | PEDIATRIC BELLOWS Draeger Medical, Inc. | CBK |
| Dec 16, 1986 | K864129 | OHMEDA 7400 ANESTHESIA VENTILATOR Ohmeda Medical | CBK |
| Dec 15, 1986 | K864379 | EMERSON 3MV VOLUME VENTILATOR J. H. Emerson Co. | CBK |
| Nov 7, 1986 | K864105 | LUNG MECHANICS SOFTWARE PROGRAM Siemens Elema AB | CBK |
| Sep 18, 1986 | K863546 | CPU GRAPH Ohmeda Medical | CBK |
| Sep 18, 1986 | K862712 | EMERSON MODEL 3HV COMPACT VENTILATOR J. H. Emerson Co. | CBK |
| Sep 15, 1986 | K862810 | COMPANION 2500 PORTABLE VOLUME VENTILATOR Puritan Bennett Corp. | CBK |
| Aug 1, 1986 | K862604 | 7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT Puritan Bennett Corp. | CBK |
| Jul 10, 1986 | K860798 | ARF-1500 CONTINUOUS VENTILATOR Medimex, Inc. | CBK |
| Jun 23, 1986 | K862212 | LIFECARE REMOTE ALARM #34-001 Lifecare Services, Inc. | CBK |
| Jun 19, 1986 | K861707 | MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR Siemens Elema AB | CBK |
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