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 |
|---|---|---|---|
| Jan 30, 1997 | K964363 | BIPAP DUET SYSTEM Respironics, Inc. | BZD |
| Dec 5, 1996 | K962203 | WHISPER SWIVEL II EXHALATION PORT Respironics, Inc. | BZD |
| Nov 14, 1996 | K963250 | PRESSURE VALVE Respironics, Inc. | BZD |
| Oct 23, 1996 | K962713 | DPAP STEALTH SLEEPNET MODEL NUMBER 84000 Sleepnet Corporation | BZD |
| Sep 30, 1996 | K953930 | VIRTUOSO SMART CPAP SYSTEM Respironics, Inc. | BZD |
| Aug 15, 1996 | K961915 | SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE Respironics, Inc. | BZD |
| Aug 1, 1996 | K961783 | SULLIVAN VPAP II ST NASAL VPAP SYSTEM Resmed, Ltd., AU | BZD |
| Jul 29, 1996 | K943207 | NITELIFE BI-LEVEL CPAP Airsep Corp. | BZD |
| Jul 18, 1996 | K961626 | SOLO CPAP SYSTEM Respironics, Inc. | BZD |
| Jul 2, 1996 | K952429 | RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM Rescare , Ltd. | BZD |
| Jun 26, 1996 | K954572 | MAESTRO CLINICAL REMOTE CONTROL Respironics, Inc. | BZD |
| Jun 13, 1996 | K953697 | THE IMS DPAP MASK, IMS MODEL NUMBER 82000 Sleepnet Corporation | BZD |
| May 28, 1996 | K952475 | SULLIVAN NOSE & MOUTH MASK SYSTEM Rescare , Ltd., AU | BZD |
| May 9, 1996 | K960518 | THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM Puritan Bennett Corp. | BZD |
| May 7, 1996 | K952966 | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Nidek Medical Products, Inc. | BZD |
| Feb 8, 1996 | K950849 | MODEL #7354 Devilbiss Health Care, Inc. | BZD |
| Jan 31, 1996 | K954207 | GEL MASK Respironics, Inc. | BZD |
| Jan 31, 1996 | K952491 | MODEL 7355 Devilbiss Health Care, Inc. | BZD |
| Jan 31, 1996 | K945938 | RESPIRONICS MONARCH MINI MASK Respironics, Inc. | BZD |
| Jan 30, 1996 | K953341 | ARIA CPAP SYSTEM Respironics, Inc. | BZD |
| Nov 13, 1995 | K952292 | PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM Puritan Bennett Corp. | BZD |
| Sep 21, 1995 | K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) Healthdyne, Inc. | BZD |
| Mar 29, 1995 | K936047 | SPECTRUM(TM) MASK Respironics, Inc. | BZD |
| Feb 27, 1995 | K934804 | PURITAN-BENNETT COMPANION 320 I/E Puritan Bennett Corp. | BZD |
| Nov 28, 1994 | K933184 | POSITIVE AIRWAY PRESSURE SYSTEM Innovative Medical Systems, Inc. | BZD |
| Nov 10, 1994 | K935979 | CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM Devilbiss Health Care, Inc. | BZD |
| Nov 10, 1994 | K933947 | LIFECARE CPAP-200 Lifecare International,Inc. | BZD |
| Aug 5, 1994 | K943509 | 7300 NASAL CPAP SYSTEM Healthdyne Technologies, Inc. | BZD |
| Jul 13, 1994 | K935784 | PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM Puritan-Bennett | BZD |
| Jun 7, 1994 | K931884 | SULLIVAN NASAL VPAP SYSTEM Rescare , Ltd. | BZD |
| Mar 15, 1994 | K930656 | SULLIVAN III NASAL CPAP SYSTEM Rescare , Ltd. | BZD |
| Feb 17, 1994 | K931484 | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S Portable Power Systems, Inc. | BZD |
| Sep 14, 1993 | K925587 | NASAL/ORAL MASK Respironics, Inc. | BZD |
| Jul 21, 1993 | K925920 | TOTAL FACE MASK Respironics, Inc. | BZD |
| Apr 9, 1993 | K923590 | 318A RESPIRATORY SUPPORT SYSTEM Puritan Bennett Corp. | BZD |
| Dec 7, 1992 | K920699 | REMSTAR WTIH RAMP AND REMOTE MODIFICATION Respironics, Inc. | BZD |
| Oct 18, 1991 | K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL Vital Signs, Inc. | BZD |
| Sep 23, 1991 | K912224 | LIFECARE CPAP-100 Lifecare Services, Inc. | BZD |
| Aug 9, 1991 | K911856 | RESPIRONICS REMSTAR WITH REMOTE AND RAMP Respironics, Inc. | BZD |
| Jul 30, 1991 | K912434 | SALTER LABS INFANT NASAL CPAP CANNULA Salter Labs | BZD |
| Jun 24, 1991 | K911780 | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED Ackrad Laboratories | BZD |
| May 13, 1991 | K910194 | COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM Puritan Bennett Corp. | BZD |
| May 13, 1991 | K905404 | MEDTRONIC SULLIVAN NASAL CPAP SYSTEM Medtronic Vascular | BZD |
| May 1, 1991 | K904344 | SLEEPER MASK SYSTEM Devilbiss Health Care, Inc. | BZD |
| Apr 23, 1991 | K905593 | SLEEPAP Medical Industries America, Inc. | BZD |
| Mar 26, 1991 | K904766 | DEVILBISS MODEL 7352 SERIES Devilbiss Health Care, Inc. | BZD |
| Jan 30, 1991 | K905540 | RESPIRONICS BIPAP REMOTE CONTROL UNIT Respironics, Inc. | BZD |
| Oct 30, 1989 | K895031 | MODIFIED INFANT NASAL CANNULAE ASSEMBLY Ackrad Laboratories | BZD |
| May 14, 1987 | K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP Holter-Hausner Intl. | BZD |
| Apr 21, 1987 | K871157 | C.P.A.P. NASAL CANNULA Hudson Oxygen Therapy Sales Co. | BZD |
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