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 |
|---|---|---|---|
| Oct 13, 2011 | K103434 | 3B FLEX-LITE 3B Products, LLC | BZD |
| Oct 7, 2011 | K110471 | BABI PLUS INFANT NASAL CANNULA SYSTEM A Plus Medical | BZD |
| Aug 19, 2011 | K110316 | INFOSEND GSM Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Aug 1, 2011 | K110383 | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 A Plus Medical | BZD |
| Jul 12, 2011 | K110884 | EASYFIT SILKGEL NASAL MASK Weinmann Gerate Fur Medizin GmbH + Co. KG, DE | BZD |
| Jun 30, 2011 | K111148 | S8 ASPEN WITH H4I PLUS Resmed Corp | BZD |
| Jun 10, 2011 | K102625 | VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 Vega Technologies, Inc., TW | BZD |
| Jun 6, 2011 | K110405 | TRUBLUE NASAL MASK Respironics, Inc. | BZD |
| May 17, 2011 | K102317 | IQ VENTILATION NASAL MASK Sleepnet Corporation | BZD |
| May 6, 2011 | K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK Apex Medical Corp., TW | BZD |
| Mar 30, 2011 | K103410 | NEOPAP SYSTEM Childrens Medical Ventures, LLC | BZD |
| Mar 24, 2011 | K103786 | ZEST PETITE NASAL MASK Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Mar 24, 2011 | K103395 | PERFORMAX TOTAL FACE MASK Respironics, Inc. | BZD |
| Mar 18, 2011 | K102586 | S9 VPAP ADAPT WITH H5I Resmed, Ltd. | BZD |
| Mar 16, 2011 | K110444 | MIRAGE MICRO Resmed, Ltd. | BZD |
| Mar 11, 2011 | K102515 | NP15 Weinmann Gerate Fur Medizin GmbH + Co. KG, DE | BZD |
| Feb 17, 2011 | K110008 | GOLIFE NASAL MASK Respironics, Inc. | BZD |
| Jan 5, 2011 | K102513 | S9 VPAP ST WITH H5I Resmed, Ltd. | BZD |
| Dec 28, 2010 | K102746 | MIRAGE FX Resmed, Ltd. | BZD |
| Dec 22, 2010 | K102502 | GOLIFE NASAL MASK Respironics, Inc. | BZD |
| Dec 10, 2010 | K102224 | PIXI PEDIATRIC MASK Resmed, Ltd. | BZD |
| Oct 8, 2010 | K100011 | FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jul 13, 2010 | K100121 | MODEL 300157 CPAP SYSTEM Aeiomed, Inc. | BZD |
| Jun 9, 2010 | K100772 | MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) Resmed, Ltd. | BZD |
| May 13, 2010 | K093716 | BABI PLUS INFANT NASAL CANNULA SYSTEM A Plus Medical | BZD |
| Apr 27, 2010 | K094040 | F&P ICON SERIES CPAP Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Apr 23, 2010 | K100343 | PAP-CAP Pur-Sleep, Inc. | BZD |
| Mar 10, 2010 | K093124 | PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 Cardinal Health 207, Inc. | BZD |
| Feb 26, 2010 | K093684 | EASYCARE ONLINE Resmed, Ltd. | BZD |
| Feb 12, 2010 | K092835 | COMFORTGEL NASAL MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Nov 5, 2009 | K090804 | NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD Innomed Technologies, Inc./Respcare, Inc. | BZD |
| Nov 2, 2009 | K092362 | SLEEPWEAVER NASAL CPAP MASK Circadiance, LLC | BZD |
| Oct 2, 2009 | K092026 | EASYCARE TX, TX LINK Resmed, Ltd. | BZD |
| Sep 28, 2009 | K091947 | S8 ASPEN WITH H4I PLUS Resmed, Ltd. | BZD |
| Sep 28, 2009 | K091919 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST Sunrise Medical | BZD |
| Sep 10, 2009 | K091843 | COMFORT TWIN NASAL MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Sep 3, 2009 | K091066 | COMFORT TWIN NASAL MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Aug 3, 2009 | K091319 | REMSTAR AUTO A-FLEX Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Aug 3, 2009 | K091129 | QUATTRO LT Resmed, Ltd. | BZD |
| Jul 1, 2009 | K090935 | MINIME PEDIATRIC MASK Sleepnet Corporation | BZD |
| May 29, 2009 | K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| May 15, 2009 | K091112 | RESPIRONICS SLEEPEASY CPAP SYSTEM Respironics, Inc. | BZD |
| May 8, 2009 | K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM Respironics Inc., Sleep & Home Respiratory Group | BZD |
| May 6, 2009 | K090490 | MIRAGE ECHO Resmed Corp | BZD |
| Apr 22, 2009 | K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 Apex Medical Corp., TW | BZD |
| Apr 13, 2009 | K090244 | SWIFT FX Resmed, Ltd. | BZD |
| Mar 25, 2009 | K082558 | COMFORTLITE NASAL MASK Respironics, Inc. | BZD |
| Mar 20, 2009 | K083816 | RES TRAXX ONLINE, MODEL: R14 Resmed, Ltd. | BZD |
| Mar 16, 2009 | K083832 | ZEST NASAL MASK Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jan 30, 2009 | K082866 | REVOLUTIONFULL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
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