Airway, Nasopharyngeal
Anesthesiology · 21 CFR 868.5100
Recent MDR events
312 adverse event reports on file
- TRACHEAL TUBEFeb 20, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00032
- TRACHEAL TUBEFeb 20, 2026InjuryTeleflex Medical Sdn. Bhd.8040412-2026-00031
- SHILEYJan 14, 2026MalfunctionCovidien Ag Juarez (mmj)9681384-2026-00099
- ADJUSTABLE FLANGE AIRWAY - 22 FRDec 24, 2025MalfunctionTeleflex Medical Sdn. Bhd.8040412-2025-00275
- ADJUSTABLE FLANGE AIRWAY - 22 FRDec 24, 2025MalfunctionTeleflex Medical Sdn. Bhd.8040412-2025-00276
- PORTEX AIRWAY NASOPHARYNGEALAug 19, 2025MalfunctionIcu Medical, Inc9616567-2025-00043
- RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREEJul 31, 2025MalfunctionTeleflex Medical Sdn. Bhd.8040412-2025-00191
- RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREEJul 31, 2025MalfunctionTeleflex Medical Sdn. Bhd.8040412-2025-00192
- SHILEYJul 30, 2025MalfunctionCovidien Ag Juarez (mmj)9611018-2025-00002
- SHILEYJul 30, 2025MalfunctionCovidien Ag Juarez (mmj)9611018-2025-00001
Event type breakdown
Recalls
2 recall events for this product code
- Smiths Medical ASD Inc.Open, ClassifiedOct 23, 2024
smiths medical portex, Nasopharyngeal Airway, Sizes as follows:
Uncertainty in the seal integrity of the sterile packaging.
Z-0143-2025 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132
Labeling error
Z-1519-2017 · View FDA record ↗
Registered firms
126 firms currently registered for this product code
Nantong Kangjinchen Medical Equipment Co., Ltd.
Nantong Jiangsu, CN
Tender Corporation
Littleton, NH, US
Hospital Equipment Mfg. Co.
NOIDA Uttar Pradesh, IN
Rhenus Se & Co. Kg
Holzwickede North Rhine-Westphalia, DE
Omnimate Enterprise Co., Ltd.
Ilan County Yilan, TW
Suru International Pvt Ltd
DAHANU Maharashtra, IN
Emsrun Group
Wuxi Jiangsu, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Medsource Labs, Llc
Chanhassen, MN, US
Xianju Jf Medister Co., Ltd.
Taizhou Zhejiang, CN
Lightning X Products, Inc
Charlotte, NC, US
Vermont Manufacturing Services, Inc.
West Rutland, VT, US
Create Biotech Co., Ltd.
Taoyuan City, TW
Yiwu Kebon Healthcare Co., Ltd.
Yiwu Zhejiang, CN
Doctor In The House
Blue Bell, PA, US
Safeguard Us Operating, Llc
Huntersville, NC, US
Apollo Renal Therapeutics, Llc
Ocala, FL, US
Teleflex Medical Llc
Morrisville, NC, US
Bioseal
PLACENTIA, CA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Hangzhou Formed Medical Devices Co., Ltd.
Hangzhou Zhejiang, CN
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Enter Medical Corporation
Chiayi County, TW
Joykey Industrial (pinghu) Limited
Pinghu City Zhejiang, CN
Dragon Medical Co.,ltd
Suzhou City Jiangsu, CN
510(k) clearances
19 clearances for this product code
- Ad-Tech Medical Instrument CorpSep 19, 1995
K940320 · AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
- Coast Medical Corp.Jun 11, 1992
K921353 · NASOPHARYNGEAL AIRWAY
- North American Sterilization & Packaging Co.Sep 23, 1991
K911784 · NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
- Eastmed Enterprises, Inc.Jan 8, 1991
K903618 · ROBERTAZZI NASOPHARYNGEAL AIRWAY
- Polamedco, Inc.Apr 19, 1990
K900456 · POLAMEDCO NASOPAHARYNGEAL AIRWAY
- Chatham IndustriesMar 28, 1990
K901279 · CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY
- Exmoor Plastics , Ltd.Nov 21, 1988
K883668 · SUNDERLAND NASAL TUBE
- Penn Medical Devices, Inc.Oct 20, 1987
K873949 · RORERTAZZI NASOPHARYNGEAL AIRWAY