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 |
|---|---|---|---|
| Jul 5, 2019 | K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask Sleepnet Corporation | BZD |
| May 17, 2019 | K182394 | WiZARD 310/320 Series CPAP Mask Apex Medical Corp., TW | BZD |
| May 7, 2019 | K183512 | Moore Park Mask Resmed, Ltd., AU | BZD |
| Jan 4, 2019 | K181053 | Care Orchestrator Respironics, Inc. | BZD |
| Nov 30, 2018 | K180388 | Transcend 365 miniCPAP System Somnetics International, Inc. | BZD |
| Aug 8, 2018 | K173193 | F&P SleepStyle Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jun 15, 2018 | K180497 | Scone Mask Resmed, Ltd., AU | BZD |
| Mar 30, 2018 | K172335 | Bleep DreamPort Snapcpap | BZD |
| Jan 3, 2018 | K170924 | AirFit F20 Resmed, Ltd., AU | BZD |
| Sep 28, 2017 | K171212 | AirFit N20 Resmed, Ltd., AU | BZD |
| Sep 5, 2017 | K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) Bmc Medical., Ltd., CN | BZD |
| Mar 15, 2017 | K162905 | SleepWeaver 3D Nasal Mask Circadiance, LLC | BZD |
| Jan 24, 2017 | K161686 | F&P InfoSmart Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Jan 18, 2017 | K161412 | F&P Brevida Nasal Pillows Mask Fisher & Paykel Healthcare, Ltd., NZ | BZD |
| Dec 15, 2016 | K160836 | Menai System Resmed, Ltd., AU | BZD |
| Nov 17, 2016 | K161978 | AirFit N20 Resmed, Ltd., AU | BZD |
| Nov 10, 2016 | K160127 | iCodeConnect 3B Medical, Inc. | BZD |
| Sep 20, 2016 | K153505 | F&P Eson 2 Nasal Mask Fisher & Paykel Healthcare Limited, NZ | BZD |
| Sep 9, 2016 | K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV Resmed, Ltd., AU | BZD |
| Sep 8, 2016 | K153387 | Luna CPAP and Auto CPAP System 3B Medical, Inc. | BZD |
| May 13, 2016 | K153563 | AirFit F20 Resmed, Ltd., AU | BZD |
| May 2, 2016 | K153673 | AirFit N20 Resmed, Ltd., AU | BZD |
| Apr 15, 2016 | K151120 | Simple T Pediatric Nasal Mask Respironics, Inc. | BZD |
| Apr 5, 2016 | K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask Circadiance, LLC | BZD |
| Jan 21, 2016 | K152810 | DeVilbiss DV6WM Wireless Modem Devilbiss Healthcare, LLC | BZD |
| Jan 8, 2016 | K152356 | Sapphire Respironics, Inc. | BZD |
| Sep 18, 2015 | K150639 | AF541 EE Full Face Mask Respironics, Inc. | BZD |
| Sep 18, 2015 | K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE Devilbiss Healthcare, LLC | BZD |
| Sep 15, 2015 | K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series Apex Medical Corp., TW | BZD |
| Aug 24, 2015 | K150685 | Skynector CPAP Mask Sky Wise Medical Instrument (Shen Zhen) Co., Ltd., CN | BZD |
| Aug 5, 2015 | K143700 | CPAP Cannulaide Salter Labs | BZD |
| Jul 21, 2015 | K150365 | Cloud9 System Insleep Technologies, LLC | BZD |
| May 21, 2015 | K143603 | Darlinghurst Vented, Darlinghurst NV-AAV Resmed, Ltd., AU | BZD |
| Apr 22, 2015 | K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM 3B Medical, Inc. | BZD |
| Feb 10, 2015 | K140980 | TI NASAL MASK Respironics, Inc. | BZD |
| Jan 16, 2015 | K140580 | REVOLUTION FULLFACE MASK Respironics Inc. (Dba Philips Respironics) | BZD |
| Jan 9, 2015 | K142554 | Revolution Full Face Mask Respironics, Inc. | BZD |
| Oct 20, 2014 | K140268 | SIMPLE T YOUTH NASAL MASK Respironics, Inc. | BZD |
| Oct 17, 2014 | K141152 | ADVANTAGE Stevenson Industries, Inc. | BZD |
| Oct 17, 2014 | K140929 | Z1 CPAP SYSTEM Human Design Medical, LLC | BZD |
| Oct 6, 2014 | K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES Apex Medical Corp., TW | BZD |
| Aug 25, 2014 | K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A 3B Medical, Inc. | BZD |
| Aug 4, 2014 | K140880 | DEVILBISS SMARTLINK II SYSTEM Devilbiss Healthcare, LLC | BZD |
| Jul 31, 2014 | K140279 | S9 GREENHILLS Resmed, Ltd. | BZD |
| Jun 17, 2014 | K140159 | S9 WANDA VPAP ST Resmed, Ltd. | BZD |
| Jun 9, 2014 | K132901 | AIRSOFT F15 Resmed, Ltd. | BZD |
| May 16, 2014 | K140054 | RESCAN Resmed, Ltd. | BZD |
| May 12, 2014 | K140124 | S9 ELOUERA Resmed Corp | BZD |
| Apr 23, 2014 | K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK BMC Medical Co., Ltd., CN | BZD |
| Jan 13, 2014 | K132606 | S9 CRONULLA FOR HER Resmed, Ltd. | BZD |
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