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 |
|---|---|---|---|
| Apr 2, 2004 | K040566 | RESMED HOSPITAL NASAL MASK Resmed, Ltd. | BZD |
| Mar 12, 2004 | K031064 | INVACARE POLARIS EX CPAP, MODEL ISP3000 Invacare Corp. | BZD |
| Mar 10, 2004 | K033841 | RESMED S8 PRIME CPAP SYSTEM Resmed, Ltd. | BZD |
| Mar 10, 2004 | K030797 | S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM Resmed Corp | BZD |
| Mar 4, 2004 | K032834 | BIPAP PRO 2 BI-LEVEL SYSTEM Respironics, Inc. | BZD |
| Mar 3, 2004 | K031935 | TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 Tiara Medical Systems, Inc. | BZD |
| Feb 20, 2004 | K032056 | BILEVEL CPAP, MODEL 9055 SERIES Sunrise Medical | BZD |
| Feb 19, 2004 | K033759 | C2 NASAL MASK Respironics, Inc. | BZD |
| Feb 13, 2004 | K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION Sensor Medics Corp. | BZD |
| Feb 4, 2004 | K022650 | APEX MEDICAL CPAP RT 21XX Apex Medical Corp., TW | BZD |
| Jan 14, 2004 | K033087 | ORACLE ORAL MASK, MODEL HC451A Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Dec 4, 2003 | K032916 | MIRAGE ACTIVA MASK Resmed, Ltd. | BZD |
| Dec 1, 2003 | K023683 | MULTI-STRAP FULL FACE MASK Engineered Medical Systems | BZD |
| Oct 24, 2003 | K032433 | NASAL JACKS MASK Resmed, Ltd. | BZD |
| Oct 16, 2003 | K032480 | AUTOSET SPIRIT SYSTEM Resmed, Ltd. | BZD |
| Oct 15, 2003 | K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I Vital Signs, Inc. | BZD |
| Sep 9, 2003 | K030563 | ARABELLA NCPAP MASKS Hamilton Medical AG | BZD |
| Aug 25, 2003 | K031883 | LYRA NASAL MASK Sensor Medics Corp. | BZD |
| Aug 19, 2003 | K031047 | MIRAGE VISTA MASK Resmed, Ltd. | BZD |
| Aug 15, 2003 | K030843 | VPAP III Resmed, Ltd. | BZD |
| Jul 23, 2003 | K014074 | HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION Hoffrichter GmbH | BZD |
| Jul 2, 2003 | K024191 | S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK Resmed, Ltd. | BZD |
| Jun 24, 2003 | K031460 | MODIFICATION TO REMSTAR AUTO CPAP SYSTEM Respironics, Inc. | BZD |
| Jun 12, 2003 | K023670 | SINGLE USE ORAL MASK, MODEL HC455A Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jun 12, 2003 | K023559 | FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jun 5, 2003 | K031470 | PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US Tyco Healthcare Nancy | BZD |
| Jun 3, 2003 | K030822 | 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS Hans Rudolph, Inc. | BZD |
| May 28, 2003 | K023068 | PAPILLON MASK SET Map Medizintechnik Fur Arzt Und Patient GmbH | BZD |
| Apr 9, 2003 | K030798 | MIRAGE ACTIVA MASK Resmed, Ltd. | BZD |
| Mar 21, 2003 | K022465 | MODIFICATION TO NASAL-AIRE Innomed Technologies | BZD |
| Feb 11, 2003 | K022642 | TWLIGHT, MODEL ISP 9600 Invacare Corp. | BZD |
| Jan 24, 2003 | K022192 | PEGASUS NASAL CPAP SYSTEM Sensor Medics Corp. | BZD |
| Nov 27, 2002 | K023306 | MIRAGE FULL FACE MASK SERIES 2 Resmed, Ltd. | BZD |
| Nov 27, 2002 | K023284 | MIRAGE FULL FACE MASK SERIES 2 Resmed, Ltd. | BZD |
| Nov 27, 2002 | K023244 | MIRAGE FULL FACE MASK SERIES 2 Resmed, Ltd. | BZD |
| Nov 14, 2002 | K022934 | SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits, DE | BZD |
| Nov 1, 2002 | K020886 | PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US Tyco Healthcare Nancy, FR | BZD |
| Oct 29, 2002 | K020641 | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 Worldwide Medical Technologies, LLC | BZD |
| Aug 13, 2002 | K020759 | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT Hans Rudolph, Inc. | BZD |
| Jul 16, 2002 | K013843 | AUTOSET SPIRIT CPAP SYSTEM Resmed Corp | BZD |
| Jul 8, 2002 | K013909 | S7 ELITE CP AP SYSTEM Resmed Corp | BZD |
| Jul 2, 2002 | K021534 | IQ NASAL MASK, MODEL 50160 REV. D Sleepnet Corporation | BZD |
| Jun 19, 2002 | K021861 | REMSTAR PRO WITH C-FLEX CPAP SYSTEM Respironics, Inc. | BZD |
| May 22, 2002 | K020730 | ORION NASAL CPAP SYSTEM Bird Products Corp. | BZD |
| Jan 29, 2002 | K012554 | REMSTAR AUTO CPAP SYSTEM Respironics, Inc. | BZD |
| Jan 22, 2002 | K013738 | WEINMANN SOMNOMASK Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits, DE | BZD |
| Jan 8, 2002 | K013421 | LIFEGUARD NASAL CPAP MASK AND ACCESSORIES Lifeguard Medical Products, Inc. | BZD |
| Nov 2, 2001 | K013306 | MINIME NASAL MASK, MODEL P/N 50220 Sleepnet Corporation | BZD |
| Jul 24, 2001 | K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT Sensor Medics Corp. | BZD |
| Jul 23, 2001 | K012207 | ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 Tiara Medical Systems, Inc. | BZD |
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