Mask, Gas, Anesthetic
Anesthesiology · 21 CFR 868.5550
Recent MDR events
115 adverse event reports on file
- MEDLINEJul 17, 2026MalfunctionMedline Industries, Lp1417592-2026-05964
- MEDLINEJul 17, 2026MalfunctionMedline Industries, Lp1417592-2026-05973
- BREATHING CIRCUITMay 15, 2026MalfunctionCovidien9680661-2026-00037
- VITAL SIGNSFeb 12, 2026MalfunctionAirlife1314417-2026-00008
- VENTLABAug 15, 2025MalfunctionVentlab Llc1314417-2025-00059
- PORTEX PERMIUM PLUS ANESTHESIA BREATHING MASKMay 8, 2025MalfunctionSmiths Medical Asd, Inc.3012307300-2025-05360
- MASK,ANESTH,NEO,SZ1,TOP VALVE,CHERRYMay 1, 2024InjuryMedline Industries Lp1417592-2024-00555
- MEDLINEApr 3, 2024MalfunctionMedline Industries, Inc.19031411
- PORTEX PERMIUM PLUS ANESTHESIA BREATHING MASKApr 3, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-02004
- PORTEX GENERAL ANESTHESIA PREMIUM PLUS MASKSJan 15, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-00222
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
169 firms currently registered for this product code
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Plasti-med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.
Tuzla Istanbul, TR
Create Biotech Co., Ltd.
Taoyuan City, TW
Veenak International Limited
BIRMINGHAM, GB
Sunmed Ap, Ltd., Warehouse No. 2
ZHUHAI Guangdong, CN
Pulmodyne Inc.
Indianapolis, IN, US
Zhejiang Medtec Medical Devices Co., Ltd
Hangzhou Zhejiang, CN
Ningbo Runmai Medical Technology Co., Ltd.
Cixi Zhejiang, CN
Foremount Enterprise Co., Ltd.
Taichung City, TW
Keystone Industries
Myerstown, PA, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Besmed Health Business Corporation
New Taipei City, TW
Guangdong Ecan Medical Co,ltd
Guangzhou Guangdong, CN
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
An Lanh Investment And Trading Company Limited
Thanh Nam Ward Ninh Binh, VN
Galemed Corp.
WU-JIA Yilan, TW
B. Ali Impex
SIALKOT, Punjab, PK
Sunmed Ap, Ltd.
ZHUHAI Guangdong, CN
Fte Dynamics, Llc
Chino Hills, CA, US
Ambu Limited
XIANG YU F.T.Z., XIAMEN Fujian, CN
Hsiner Co., Ltd.
Taichung City, TW
Ambu Mexico Operations S.a. De C.v.
Ciudad Juarez Chihuahua, MX
510(k) clearances
51 clearances for this product code
- Revolutionary Medical Devices, Inc.Oct 13, 2017
K163277 · SuperNO2VA Device
- Medical Marketing ConceptsAug 15, 1995
K953107 · ANESTHESIA/RESPIRATORY FACE MASK
- Mallinckrodt MedicalAug 11, 1995
K953295 · ANESTHESIA FACE MASK
- Owens-Brigam Medical Co.Jul 11, 1995
K952689 · BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
- Promedic, Inc.Jun 7, 1995
K951043 · AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
- Advanced Warming Systems, Inc.Mar 10, 1995
K950771 · DISPOSABLE ADHESIVE FACE MASK
- Hans Rudolph, Inc.Jan 27, 1995
K945894 · MASK, GAS, ANESTHETIC
- FvtnksNov 8, 1994
K945440 · DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK