BZD
AirFit N20
- Advisory panel
- Anesthesiology
- Total cleared
- 455
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code BZD
1–100 of 455- K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- K253939 — DeltaWave Nasal Pillow System
- K251770 — SleepRes PAP System
- K251657 — Personalized Therapy Comfort Settings (PTCS)
- K243583 — F&P Nova Nasal Mask
- K250624 — myAir
- K243023 — WiZARD 520 Full Face Mask
- K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System
- K242935 — Respiration Data Management Software (PAP Link PC)
- K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
- K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
- K241939 — EasyCare Tx 2
- K241216 — myAir
- K234134 — AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
- K233829 — Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)
- K233555 — AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
- K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
- K233415 — DELTAWAVE Nasal Pillows System
- K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
- K230476 — Oran Park Mask
- K231313 — Therapy Mask 3100 NC/SP
- K223747 — Whitsundays Mask System
- K221436 — F&P 950 Accessory Breathing Circuit Kits
- K223696 — F&P Solo Mask Range
- K212263 — Luna G3 BPAP System
- K212371 — F&P Evora Full Face Mask
- K211155 — Auto CPAP System
- K211274 — iQ 2 Nasal Mask, Phantom 2 Nasal Mask
- K210844 — DreamWear Silicone Pillows Mask
- K210386 — Magneto Nasal Mask
- K203347 — Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
- K203601 — Innova Nasal Non-Vented Mask
- K201620 — Luna® G3 BPAP 25A
- K200565 — Galapogos
- K203126 — S10 Kirra
- K192177 — SysMed S/T
- K193206 — WiZARD 510 Nasal Mask
- K201439 — Ventilator, Non-continuous (Respirator)
- K200480 — DreamStation 2 System, DreamStation 2 Advanced System
- K200089 — F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
- K183226 — Care Orchestrator Essence
- K190713 — F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
- K190254 — Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
- K182394 — WiZARD 310/320 Series CPAP Mask
- K183512 — Moore Park Mask
- K181053 — Care Orchestrator
- K180388 — Transcend 365 miniCPAP System
- K173193 — F&P SleepStyle
- K180497 — Scone Mask
- K172335 — Bleep DreamPort
- K170924 — AirFit F20
- K171212 — AirFit N20
- K163464 — Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
- K162905 — SleepWeaver 3D Nasal Mask
- K161686 — F&P InfoSmart
- K161412 — F&P Brevida Nasal Pillows Mask
- K160836 — Menai System
- K161978 — AirFit N20
- K160127 — iCodeConnect
- K153505 — F&P Eson 2 Nasal Mask
- K160822 — S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
- K153387 — Luna CPAP and Auto CPAP System
- K153563 — AirFit F20
- K153673 — AirFit N20
- K151120 — Simple T Pediatric Nasal Mask
- K151683 — SleepWeaver Advance Pediatric Nasal CPAP Mask
- K152810 — DeVilbiss DV6WM Wireless Modem
- K152356 — Sapphire
- K143677 — DeVilbiss Intellipap2/DeVilbiss BLUE
- K150639 — AF541 EE Full Face Mask
- K150111 — Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
- K150685 — Skynector CPAP Mask
- K143700 — CPAP Cannulaide
- K150365 — Cloud9 System
- K143603 — Darlinghurst Vented, Darlinghurst NV-AAV
- K141770 — LUNA CPAP AND AUTO-CPAP SYSTEM
- K140980 — TI NASAL MASK
- K140580 — REVOLUTION FULLFACE MASK
- K142554 — Revolution Full Face Mask
- K140268 — SIMPLE T YOUTH NASAL MASK
- K140929 — Z1 CPAP SYSTEM
- K141152 — ADVANTAGE
- K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
- K133769 — 3B RESMART BPAP 25A, BMC RESMART BPAP 25A
- K140880 — DEVILBISS SMARTLINK II SYSTEM
- K140279 — S9 GREENHILLS
- K140159 — S9 WANDA VPAP ST
- K132901 — AIRSOFT F15
- K140054 — RESCAN
- K140124 — S9 ELOUERA
- K133009 — NASAL MASK, NASAL MASK, FULL FACE MASK
- K130828 — K SERIES CPAP SYSTEMS
- K132606 — S9 CRONULLA FOR HER
- K131901 — IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
- K132887 — AIRFIT N10
- K131702 — K SERIES CPAP SYSTEMS
- K132967 — 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
- K132168 — BRONCHOSCOPY ELBOW
- K132013 — SWIFT AIR
- K131982 — REMSTAR AUTO A-FLEX HT
Data sourced from openFDA. This site is unofficial and independent of the FDA.