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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)
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Top companies in BZD

Company510(k)sRecalls
Resmed Corp979
Respironics, Inc.6825
Fisher & Paykel Healthcare Limited307
Sleepnet Corporation187
Apex Medical Corp.120
Philips Respironics110
3B Medical, Inc.91
Respironics Inc., Sleep & Home Respiratory Group100
Weinmann Gerate Fur Medizin GmbH + Co. KG90
Puritan Bennett Corp.80
Decided510(k)Device and applicantCode
Jan 13, 2009K082605VPAP AUTO WITH HUMIDAIRE 3I
Resmed, Ltd.
BZD
Jan 2, 2009K082983RESSCAN-PRO
Resmed, Ltd.
BZD
Jan 2, 2009K082979S8 ADVANCE
Resmed, Ltd.
BZD
Oct 28, 2008K082209DEVILBISS DV5M SMARTLINK SYSTEM
Sunrise Medical
BZD
Oct 9, 2008K082237PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
Mallinckrodt Developpement France
BZD
Oct 9, 2008K081321MODIFICATION TO MIRAGE MICRO
Resmed, Ltd.
BZD
Sep 12, 2008K081029SLEEPSTYLE 200 AUTO SERIES HC254
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Sep 12, 2008K080209FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Jun 23, 2008K080516LAMIN AIR
Remgenic, LLC
BZD
May 16, 2008K080439SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
Mallinckrodt Developpement France
BZD
May 14, 2008K071915CPAP MASK
Arcimed Laboratories, LLC
BZD
May 9, 2008K081014SOYALA GEL VENTED
Weinmann Gerate Fur Medizin GmbH + Co. KG, DE
BZD
Apr 25, 2008K073600COMFORTGEL FULL FACE MASK
Respironics Inc., Sleep & Home Respiratory Group
BZD
Apr 8, 2008K080079S8 ESCAPE II
Resmed, Ltd.
BZD
Apr 1, 2008K080131VPAP ST
Resmed, Ltd.
BZD
Mar 28, 2008K073673SOYALA FULL FACE MASK GEL VENTED
Weinmann Gerate Fur Medizin GmbH + Co. KG, DE
BZD
Mar 20, 2008K073638SWIFT LT
Resmed, Ltd.
BZD
Feb 8, 2008K072993REUSABLE HEADREST WITH NASAL SEAL
Aeiomed, Inc.
BZD
Feb 1, 2008K071149HRI 6500, 6600 AND 6700 SERIES V2MASKS
Hans Rudolph, Inc.
BZD
Jan 4, 2008K072615TXCONTROL
Resmed, Ltd.
BZD
Dec 27, 2007K072996REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
Respironics, Inc.
BZD
Dec 19, 2007K072592PERFORMAX TOTAL FACE MASK
Respironics Inc., Sleep & Home Respiratory Group
BZD
Dec 14, 2007K072009WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340
Weinmann Gerate Fur Medizin GmbH + Co. KG, DE
BZD
Dec 13, 2007K072940MIRAGE MICRO
Resmed, Ltd.
BZD
Nov 16, 2007K072755GALEMED CPAP MASK
Galemed Corp.
BZD
Oct 10, 2007K071808MIRAGE MICRO
Resmed, Ltd.
BZD
Sep 12, 2007K071773CPAP NASAL MASK WITH PILLOWS
Lifesource
BZD
Sep 10, 2007K071575SANDMAN INTRO
Mallinckrodt Developpement France
BZD
Sep 7, 2007K071689DEVILBISS INTELLIPAP MODEL DV 5 SERIES
Sunrise Medical
BZD
Jul 18, 2007K071163WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603
Weinmann Gerate Fur Medizin GmbH + Co. KG, DE
BZD
Jul 13, 2007K070746RESTRAXX DATA CENTRE, MODEL R10
Resmed, Ltd.
BZD
Jul 10, 2007K071171VPAP AUTO WITH H3I
Resmed, Ltd.
BZD
Jun 12, 2007K071069MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
Viasys Sleep Systems, LLC
BZD
May 4, 2007K070609APEX MEDICAL XT1 CPAP, MODEL 9S-005
Apex Medical Corp., TW
BZD
Apr 30, 2007K070321TWILIGHT FULL FACE MASK
Invacare Corp.
BZD
Apr 6, 2007K063501KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
Mallinckrodt Developpement France
BZD
Mar 9, 2007K063830REMSTAR AFLEX CPAP SYSTEM
Respironics Inc., Sleep & Home Respiratory Group
BZD
Feb 23, 2007K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
Hsiner Co., Ltd.
BZD
Feb 2, 2007K063122MIRAGE QUATTRO FULL FACE MASK
Resmed, Ltd.
BZD
Feb 2, 2007K063011MIRAGE LIBERTY FULL FACE MASK
Resmed, Ltd.
BZD
Jan 22, 2007K063476BREAS ISLEEP 20I
Breas Medical AB, SE
BZD
Dec 22, 2006K063036OPUS HC482 DIRECT NASAL MASK
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Nov 9, 2006K061653SOYALA FULL FACE MASK
Weinmann Gerate Fur Medizin GmbH + Co. KG, DE
BZD
Sep 8, 2006K062291VPAP MALIBU WITH H2I
Resmed, Ltd.
BZD
Sep 5, 2006K061874INVACARE'S TWILIGHT II NASAL MASKS
Invacare Corp.
BZD
Aug 29, 2006K061236FLEXIFIT HC432 FULL FACE MASK
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Aug 18, 2006K060657ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
Breas Medical AB, SE
BZD
Aug 17, 2006K062224RESPCARE HYBRID AV MASK
Respcare, Inc.
BZD
Aug 11, 2006K061099BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
Hoffman Laboratories, LLC
BZD
Jul 20, 2006K061200PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
Resmed, Ltd.
BZD

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