Panels › Anesthesiology › Product code BZD · Class 2
Ventilator, Non-Continuous (Respirator)
Regulation 868.5905
12510(k)s in 12 months (463 all time)
3recalls in 12 months (83 all time)
79recalls that name a 510(k)
Top companies in BZD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 2006 | K060067 | MASKMEDIC CONCEPT NASAL MASK Maskmedic | BZD |
| Jun 23, 2006 | K061057 | BREAS ISLEEP 20+ Breas Medical AB, SE | BZD |
| Jun 23, 2006 | K061034 | BIPAP PLUS M-SERIES BI-LEVEL SYSTEM Respironics, Inc. | BZD |
| Jun 21, 2006 | K060405 | SOYALA, SOYALA BLUE Weinmann Gerate Fur Medizin GmbH + Co. KG, DE | BZD |
| May 2, 2006 | K060273 | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 Sleepnet Corporation | BZD |
| Feb 15, 2006 | K053352 | COMFORTLITE NASAL MASK Respironics, Inc. | BZD |
| Feb 3, 2006 | K053205 | RES TRAXX DATA CENTER Resmed, Ltd. | BZD |
| Jan 4, 2006 | K053486 | TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET Hoffrichter GmbH | BZD |
| Dec 16, 2005 | K052597 | BREATHEX OMEGA CPAP DEVICE, MODEL 322 Hoffman Laboratories, LLC | BZD |
| Dec 7, 2005 | K052249 | UTOPIA Respcare, Inc. | BZD |
| Nov 17, 2005 | K051226 | AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER Cardinalhealth | BZD |
| Nov 4, 2005 | K051583 | TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 Tiara Medical Systems, Inc. | BZD |
| Oct 28, 2005 | K052227 | RESPCARE FACE MASK Respcare, Inc. | BZD |
| Oct 20, 2005 | K052110 | M-SERIES PRO CPAP SYTEM Respironics, Inc. | BZD |
| Aug 3, 2005 | K050994 | AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Cardinalhealth | BZD |
| Jul 15, 2005 | K051314 | RES TRAXX DATA CENTER Resmed, Ltd. | BZD |
| Jul 8, 2005 | K051559 | IMASK, MODELS 100, 200 AND 300 Vital Signs Colorado, Inc. | BZD |
| Jun 15, 2005 | K050759 | BIPAP AUTO Respironics, Inc. | BZD |
| Jun 13, 2005 | K050072 | GOODKNIGHT 425ST Nellcor Puritan Bennett, Inc. | BZD |
| May 25, 2005 | K050904 | CPAP HUMIDIFIER, MODEL HC238JHU Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| May 10, 2005 | K050775 | RESSCAN Resmed, Ltd. | BZD |
| May 10, 2005 | K041823 | PIONEER U121 SERIES CPAP Merits Health Products Co., Ltd., TW | BZD |
| May 4, 2005 | K050171 | IT NASAL MASK Innomed Technologies | BZD |
| Mar 16, 2005 | K050359 | ULTRA MIRAGE II MASK Resmed, Ltd. | BZD |
| Mar 9, 2005 | K042945 | AURA CPAP SYSTEM Aeiomed, Inc. | BZD |
| Mar 4, 2005 | K040202 | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM Salter Labs | BZD |
| Mar 1, 2005 | K050142 | RESMED MERIDIAN MASK Resmed, Ltd. | BZD |
| Feb 11, 2005 | K043282 | DEVILBISS AUTOADJUST, MODEL 9054 SERIES Sunrise Medical | BZD |
| Jan 28, 2005 | K043607 | BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX Respironics, Inc. | BZD |
| Jan 19, 2005 | K043382 | TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 Tiara Medical Systems, Inc. | BZD |
| Jan 14, 2005 | K042455 | DEVILBISS NASAL CPAP MASK, 9354 SERIES Sunrise Medical | BZD |
| Oct 8, 2004 | K042403 | MIRAGE SWIFT Resmed, Ltd. | BZD |
| Sep 10, 2004 | K042294 | SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) Suiter Enterprises, Inc. | BZD |
| Sep 8, 2004 | K042130 | AURA CPAP PATIENT INTERFACE Aeiomed, Inc. | BZD |
| Aug 31, 2004 | K041900 | HC604 CPAP HUMIDIFIER Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jul 30, 2004 | K041828 | APEX MEDICAL CPAP MODEL 9S-003 Apex Medical Corp., TW | BZD |
| Jul 22, 2004 | K041819 | GOODKNIGHT 425, MODELM-114500-00 Mallinckrodt Developpement France | BZD |
| Jul 15, 2004 | K041362 | RESMED HOSPITAL FULL FACE MASK Resmed, Ltd. | BZD |
| Jul 1, 2004 | K041209 | RESMED S8 PIONEER CPAP SYSTEM Resmed, Ltd. | BZD |
| Jun 30, 2004 | K041309 | IMASK TM Vital Signs, Inc. | BZD |
| Jun 30, 2004 | K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM Caradyne, Ltd., IE | BZD |
| Jun 24, 2004 | K034053 | TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 Tiara Medical Systems, Inc. | BZD |
| Jun 10, 2004 | K040941 | CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jun 9, 2004 | K041035 | HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND Hoffrichter GmbH | BZD |
| Jun 3, 2004 | K040944 | RESCONTROL II Resmed, Ltd. | BZD |
| Jun 3, 2004 | K040726 | VENTLAB NASAL CPAP CANNULA Ventlab Corp. | BZD |
| May 5, 2004 | K041010 | REMSTAR AUTO WITH C-FLEX CPAP SYSTEM Respironics, Inc. | BZD |
| May 5, 2004 | K040506 | FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| May 5, 2004 | K034033 | RESCAN Resmed, Ltd. | BZD |
| Apr 22, 2004 | K033914 | OXYGEN DIVERTER VALVE Resmed, Ltd. | BZD |
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