Monitor, Airway Pressure (includes Gauge And/or Alarm)
Anesthesiology · 21 CFR 868.2600
Recent MDR events
73 adverse event reports on file
- PORTEX CUFF PRESSURE MONITORINGJul 23, 2025MalfunctionIcu Medical Czech Republic A. S3012307300-2025-08845
- PORTEX CUFF PRESSURE MONITORINGMar 17, 2025MalfunctionSmiths Medical Czech Republic A. S3012307300-2025-02947
- PORTEX CUFF PRESSURE MONITORINGDec 17, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-14170
- GE GAS MODULENov 21, 2024MalfunctionGe Healthcare20745960
- PORTEX CUFF PRESSURE MONITORINGAug 29, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-08353
- PORTEX CUFF PRESSURE MONITORINGAug 22, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-07929
- PORTEX CUFF PRESSURE MONITORINGAug 12, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-07541
- PORTEX CUFF PRESSURE MONITORINGMay 21, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-03972
- PORTEX CUFF PRESSURE MONITORINGApr 24, 2024MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9616567-2024-00067
- PORTEX HYPERINFLATION PRESSURE MONOMETERFeb 23, 2024MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9617604-2024-00176
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
98 firms currently registered for this product code
Ambu A/s
Ballerup Hovedstaden, DK
Ge Medical Systems Information Technologies
EL PASO, TX, US
Hsiner Co., Ltd.
TAICHUNG CITY, TW
Besmed Health Business Corporation
New Taipei City, TW
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Galemed Corp.
WU-JIA Yilan, TW
Raumedic Estonia As
Tallinn Harjumaa, EE
Teleflex Medical Llc
Morrisville, NC, US
Salaera, Llc D.b.a Maxtec
Salt Lake City, UT, US
Cbr Enterprise Limited
Hong Kong, HK
Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.
JUAREZ Chihuahua, MX
Vincent Medical Manufacturing. Co., Ltd.
KOWLOON, HK
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Vortran Medical Technology 1, Inc.
SACRAMENTO, CA, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Westmed De Mexico, S.a De C.v.
Tecate Baja California, MX
510(k) clearances
78 clearances for this product code
- Flexicare Medical Limited.Nov 13, 2020
K201666 · SINGLE USE MANOMETER
- Vortran Medical Technology 1, Inc.Sep 18, 2019
K182292 · VORTRAN APM-Plus
- Instrumentation Industries, Inc.May 1, 2019
K180510 · NS 120P-TRS Airway Pressure Gauge
- Drw Medical, LLCFeb 9, 2018
K172284 · NAPA LP-15 Airway Pressure Monitor
- Vortran Medical Technology 1, Inc.Sep 16, 2016
K153733 · VORTRAN Manometer
- Westmed, Inc.Aug 11, 2015
K143148 · Disposable Pressure Manometer (DPM)
- Besmed Health Business CorpJun 19, 2014
K140370 · DISPOSABLE PRESSURE MANOMETER
- Galemed Corp.Aug 22, 2013
K122627 · GIO DIGITAL PRESSURE GUAGES