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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
Jul 11, 2001K011229DEVILBISS 9000 SERIES CPAP, MODEL 9001
Sunrise Medical Hhg, Inc.
BZD
Jun 28, 2001K011714BIPAP PRO BI-LEVEL SYSTEM
Respironics, Inc.
BZD
Jun 25, 2001K003894ORACLE ORAL MASK
Fisher & Paykel Healthcare, Ltd., NZ
BZD
Jun 8, 2001K011516INFANT FLOW SYSTEM, MODEL M672P
Eme (Electro Medical Equipment) , Ltd., GB
BZD
May 4, 2001K002763REMREST
Medical Industries America, Inc.
BZD
Apr 18, 2001K010704DORNIR LC-1 CPAP SYSTEM
Prym Medical , Ltd., IL
BZD
Mar 29, 2001K010263REMSTAR PLUS CPAP SYSTEM
Respironics, Inc.
BZD
Oct 23, 2000K993094AERO-CLICK
Map Medizintechnik Fur Arzt Und Patient GmbH, DE
BZD
Sep 8, 2000K002465SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
Respironics, Inc.
BZD
Sep 8, 2000K000705RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
Respironics, Inc.
BZD
Sep 6, 2000K002001BREEZE SLEEPGEAR WITH DREAMSEAL
Puritan Bennett Corp.
BZD
Aug 15, 2000K000888SANSIBAR CPAP SYSTEM
Prym Medical , Ltd., IL
BZD
Aug 3, 2000K001553BREAS PV 100 CPAP SYSTEM
Vital Signs, Inc.
BZD
Jul 5, 2000K001845MALLINCKRODT, GOODKNIGHT 418S
Mallinckrodt Developpement France, FR
BZD
Jun 22, 2000K000994BIPAP DUET LX BI-LEVEL SYSTEM
Respironics, Inc.
BZD
May 26, 2000K000215SWIVEL ELBOW
Engineered Medical Systems
BZD
May 12, 2000K992192AIRPILOTMASK, MODEL TMS-900
Tiara Medical Systems, Inc.
BZD
Mar 7, 2000K993584MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
Nellcor Puritan Bennett France Dvpt., FR
BZD
Jan 11, 2000K990856HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
Bird Products Corp.
BZD
Dec 1, 1999K992384CPAP/PRO CPAP INTERFACE
Stevenson Industries, Inc.
BZD
Nov 26, 1999K990659NASAL AIRE
Breathing Technologies Corp.
BZD
Nov 10, 1999K992969RESPIRONICS TOTAL FACE MASK
Respironics, Inc.
BZD
Oct 27, 1999K993433VIRTUOSO LX SMART CPAP SYSTEM
Respironics, Inc.
BZD
Oct 27, 1999K993307ARIA LX CPAP SYSTEM
Respironics, Inc.
BZD
Oct 27, 1999K993269IQ NASAL MASK, MODEL P/N 50160
Sleepnet Corporation
BZD
Oct 18, 1999K991926OPAP
Opap, Inc.
BZD
Aug 13, 1999K992336MONARCH II MINI MASK
Respironics, Inc.
BZD
Aug 13, 1999K991972INFANT FLOW SYSTEM
Sensor Medics Corp.
BZD
Jul 26, 1999K984428SULLIVAN AUTOSET NASAL CPAP SYSTEM
Resmed, Ltd.
BZD
May 28, 1999K991648REUSABLE CONTOUR II NASAL MASK
Respironics, Inc.
BZD
Apr 14, 1999K991150NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
Nellcor Puritan Bennett France Dvpt., FR
BZD
Feb 24, 1999K984254INFANT FLOW NCPAP MASKS
Sensor Medics Corp.
BZD
Jan 27, 1999K982242INVACARE CPAP
Invacare Corp.
BZD
Nov 17, 1998K980551SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Nidek Medical Products, Inc.
BZD
Oct 16, 1998K982530SULLIVAN MIRAGE FULL FACE MASK
Resmed, Ltd.
BZD
Oct 14, 1998K981744COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
W. Keith Thornton, D.D.S.
BZD
Sep 1, 1998K980721SULLIVAN AUTOSET
Resmed, Ltd.
BZD
Aug 4, 1998K974453NASAL INTERFACE MODEL 7910
Healthdyne Technologies, Inc.
BZD
Jul 22, 1998K980365GOODKNIGHT 418 CPAP SYSTEM
Nellcor Puritan Bennett, Inc.
BZD
Jul 10, 1998K973161CPAP HUMIDIFIER (HC 200)
Fisher & Paykel Electronics , Ltd., NZ
BZD
Jun 29, 1998K974879MODEL 7410 VOYAGER
Healthdyne Technologies, Inc.
BZD
Jan 30, 1998K974303INFANT FLOW SYSTEM
Sensor Medics Corp.
BZD
Jan 28, 1998K972605EMS NASAL CPAP MASK
Engineered Medical Systems
BZD
Jul 31, 1997K964092TMS COMFORT SERIES NASAL CPAP MASK
Tiara Medical Systems, Inc.
BZD
Jun 20, 1997K970771SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
Resmed, Ltd., AU
BZD
Jun 18, 1997K964019MORPHEE PLUS ALPHA
Nellcor Puritan Bennett, Inc.
BZD
May 9, 1997K970516SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
Resmed, Ltd., AU
BZD
Apr 18, 1997K963761QUARTET CLINICAL SYSTEM
Respironics, Inc.
BZD
Apr 16, 1997K970173MODEL 1700 TRANQUILITY BILEVEL SYSTEM
Healthdyne Technologies, Inc.
BZD
Mar 28, 1997K951944NASALFLAIR
Airways Ltd., Inc.
BZD

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