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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, 2014K130828K SERIES CPAP SYSTEMS
Curative Medical, Inc.
BZD
Dec 23, 2013K131901IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
3B Medical, Inc.
BZD
Dec 20, 2013K132887AIRFIT N10
Resmed, Ltd.
BZD
Dec 6, 2013K1329673B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
3B Medical, Inc.
BZD
Dec 6, 2013K131702K SERIES CPAP SYSTEMS
Curative Medical, Inc.
BZD
Nov 20, 2013K132168BRONCHOSCOPY ELBOW
Respironics, Inc.
BZD
Oct 21, 2013K132013SWIFT AIR
Resmed, Ltd.
BZD
Oct 18, 2013K131982REMSTAR AUTO A-FLEX HT
Respironics, Inc.
BZD
Oct 17, 2013K132127TRANSCEND AUTO
Somnetics International, Inc.
BZD
Oct 16, 2013K130686NASAL COMFORT FREEDOM
Lakeview Sleep Center
BZD
Oct 11, 2013K131502SEATTLE - PAP
Seattle Childrens Hospital
BZD
Sep 27, 2013K130663BESTFIT2 NASAL MASK
Curative Medical, Inc.
BZD
Aug 22, 2013K1317073B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
3B Medical, Inc.
BZD
Jun 6, 2013K121642WIZARD 230 NASAL PILOW MASK
Apex Medical Corp., TW
BZD
Jun 5, 2013K130328F&P SIMPLUS FULL FACE MASK
Fisher & Paykel Healthcare Limited, NZ
BZD
May 24, 2013K130481SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
Circadiance, LLC
BZD
May 21, 2013K130077REMSTAR SE
Respironics, Inc.
BZD
May 17, 2013K130037BREATHE CPAP SYSTEM
Breathe Technologies, Inc.
BZD
Mar 29, 2013K123789SWIFT FX NANO
Resmed, Ltd.
BZD
Mar 14, 2013K121747FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
Intersurgical Incorporated
BZD
Mar 13, 2013K123897K SERIES CPAP SYSTEMS
Curative Medical, Inc.
BZD
Mar 6, 2013K122847KANGAROO NASAL MASK
Respironics, Inc.
BZD
Feb 27, 2013K123979QUATTRO AIR
Resmed, Ltd.
BZD
Feb 22, 2013K121374ZI BLOWER
Deshum Medical
BZD
Dec 6, 2012K112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
Apex Medical Corp., TW
BZD
Nov 30, 2012K121321HARD SHELL VENTED NASAL MASK
Sleepnet Corporation
BZD
Nov 5, 2012K121692MINIME 2 NASAL MASK
Sleepnet Corporation
BZD
Nov 1, 2012K122350TAP PAP NASAL PILLOW MASK
Airway Management, Inc.
BZD
Oct 23, 2012K121705GEO
Resmed, Ltd.
BZD
Oct 9, 2012K122769REMSTAR SE
Respironics, Inc.
BZD
Oct 5, 2012K121631SIMPLE T NASAL MASK
Respironics, Inc.
BZD
Oct 2, 2012K121597ESON NASAL MASK
Fisher & Paykel Healthcare Limited, NZ
BZD
Jul 27, 2012K120463MOJO, VERASEAL
Sleepnet Corporation
BZD
Jul 17, 2012K120562PERFORMAX PEDIATRIC EE TOTAL FACE MASK
Respironics, Inc.
BZD
Jul 16, 2012K120920HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
Hsiner Company
BZD
Jul 2, 2012K120285K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
Curative Medical, Inc.
BZD
May 25, 2012K113801VPAP ADAPT
Resmed Corp
BZD
May 16, 2012K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
Apex Medical Corp., TW
BZD
Apr 27, 2012K110629RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
3B Products, Inc.
BZD
Apr 24, 2012K120757SLEEPWEAVER ELAN NASAL CPAP MASK
Circadiance, LLC
BZD
Apr 20, 2012K113780EASYCARE TX SYSTEM (CONNEXUNS)
Resmed, Ltd.
BZD
Mar 30, 2012K120145SIMPLE T NASAL MASK
Respironics, Inc.
BZD
Feb 23, 2012K120027PILAIRO NASAL PILLOWS MASK
Fisher & Paykel Healthcare Limited, NZ
BZD
Feb 16, 2012K1122713B WILLOW
3B Products, LLC
BZD
Jan 6, 2012K113127MIRAGE QUATTRO
Resmed, Ltd.
BZD
Dec 16, 2011K113068REMSTAR AUTO A-FLEX HT
Respironics, Inc.
BZD
Dec 7, 2011K112489SWIFT FX BELLA
Resmed, Ltd., AU
BZD
Nov 22, 2011K112220DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
Devilbiss Healthcare, LLC
BZD
Nov 16, 2011K112393TASMAN
Resmed, Ltd.
BZD
Nov 16, 2011K112167SOYALA SILKGEL FULL FACE MASK
Weinmann Gerate Fur Medizin GmbH + Co. KG, DE
BZD

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