ClearanceBrief
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)
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Top companies in CBK

DateFirm and productCodeLinked 510(k)
Jan 25, 2007MAQUET Inc.
Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
Terminated
CBKK010925
Jan 11, 2007Viasys Respiratory Care, Inc.
Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
Terminated
CBKK993449
Jan 11, 2007Viasys Respiratory Care, Inc.
Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653
Terminated
CBKK993449
Oct 19, 2006Respironics California Inc
Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246
Terminated
CBKK981072
Jul 22, 2006Hamilton Medical Inc
Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
Terminated
CBKK022679
K052863
Jul 22, 2006Hamilton Medical Inc
Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
Terminated
CBKK022679
K052863
Jul 22, 2006Hamilton Medical Inc
Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360,
Terminated
CBKK022679
K052863
Jul 1, 2006Respironics, Inc.
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
Terminated
CBKK040862
May 2, 2006Respironics California Inc
Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by deliver
Terminated
CBKK022750
Apr 7, 2006Respironics, Inc.
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
Terminated
CBKK040862
Feb 14, 2006Draeger Medical, Inc.
Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
Terminated
CBKK974176
Jan 6, 2006Respironics California Inc
The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuu
Terminated
CBKK022750
Nov 23, 2005Pulmonetic Systems, Inc.
Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who requ
Terminated
CBKK002881
K010608 +2
Nov 23, 2005Pulmonetic Systems, Inc.
Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who requ
Terminated
CBKK002881
K010608 +2
Nov 23, 2005Pulmonetic Systems, Inc.
Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who req
Terminated
CBKK002881
K010608 +2
Oct 15, 2005Event Medical
INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian
Terminated
CBKNone listed
Aug 17, 2005Newport Medical Instruments Inc
Newport HT50 All Purpose Ventilator
Terminated
CBKK992133
Aug 6, 2005Puritan Bennett
Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP
Terminated
CBKK970460
Jun 8, 2005Maquet Inc
Servo-i Ventilator
Terminated
CBKK040221
Mar 8, 2005Maquet Inc
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, S
Terminated
CBKK902859
K970839
Jan 29, 2005Bio-Med Devices, Inc.
Bio-Med Dental Breathing Circuit Product NUmber: DENTL
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Bio-Med Patient Breathing Circuit Product NUmber: 3030-5 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT =-=-=-
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A PATIENT BREATHING CIRCUIT =-=-=-
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENT
Terminated
CBKNone listed
Jan 29, 2005Bio-Med Devices, Inc.
Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42
Terminated
CBKNone listed
Jan 28, 2005Nellcor Puritan Bennett Inc
Model 740 and 760 series Ventilators.
Terminated
CBKK964540
K984379
Jan 28, 2005Nellcor Puritan Bennett Inc
Internal Battery for Puritan Bennett 700 Series Ventilator.
Terminated
CBKK964540
K984379
Sep 28, 2004Cardinal Health 203, Inc
The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for u
Terminated
CBKK002881
K010608 +3
Jul 28, 2004Respironics California Inc
Esprit Ventilator
Terminated
CBKK001208
K023350 +2
Jul 20, 2004Sechrist Industries Inc
Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
Terminated
CBKK811141
K833982 +1
Jul 20, 2004Respironics California Inc
Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
Terminated
CBKK981072
Jul 20, 2004Respironics California Inc
Esprit Ventilator.
Terminated
CBKNone listed
Jun 27, 2003Draeger Medical, Inc.
Evita 4 Continuous Ventilator
Terminated
CBKK010093

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