Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Gastroenterology, Urology · 21 CFR 876.5365
Recent MDR events
36 adverse event reports on file
- MALONEY TUNGSTEN FILLED BOUGIE 54FFeb 6, 2025InjuryTeleflex Medical3004365956-2025-00008
- 54 FR MALONEY DILATOR BOUGIEJan 8, 2025InjuryTeleflex MedicalMW5164475
- MALONEY TUNGSTEN FILLED BOUGIE 36FSep 13, 2024MalfunctionTeleflex Medical3004365956-2024-00065
- MALONEY TUNGSTEN FILLED BOUGIE 36FMay 6, 2024MalfunctionTeleflex Medical3004365956-2024-00042
- MALONEY TUNGSTEN FILLED BOUGIE 36FMay 3, 2024MalfunctionTeleflex Medical3004365956-2024-00041
- MALONEY TUNGSTEN FILLED BOUGIE 32FJul 11, 2023MalfunctionTeleflex Medical3004365956-2023-00049
- M-FLEX SILICONE BOUGIEJun 28, 2021InjuryDiversatek Healthcare2183446-2021-00001
- MEDOVATIONS M-FLEX SILICONE BOUGIE 54FRMay 27, 2021InjuryDiversatek Healthcare Inc.MW5101618
- DISPOSABLE LIGHTED BOUGIE TIP 40Mar 9, 2020InjuryMedovations / Diversatek Healthcare Inc.MW5093628
- ESOPHAGEAL BOUGIESJan 23, 2020MalfunctionTeleflex Medical3004365956-2020-00017
Event type breakdown
Recalls
2 recall events for this product code
- Stryker EndoscopyTerminatedFeb 1, 2011
Stryker Endoscopy, Infravision Esophageal Kit,
The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
Z-1002-2011 · View FDA record ↗ - Stryker EndoscopyTerminatedDec 28, 2010
Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.
Z-0830-2011 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
changzhou Jiangsu, CN
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Endolumik
Morgantown, WV, US
Jiangsu Vedkang Medical Science And Technology Co.,ltd.
Changzhou Jiangsu, CN
Teleflex Medical Llc
Morrisville, NC, US
Diversatek Healthcare Inc
Milwaukee, WI, US
Changzhou Jiuhong Medical Instrument Co., Ltd.
CHANGZHOU Jiangsu, CN
Teleflex Llc (nadc)
Olive Branch, MS, US
Inka Surgical Instruments
Jandakot Western Australia, AU
510(k) clearances
8 clearances for this product code
- Teleflexmedical, Inc.Jun 16, 2014
K133439 · PILLING ESOPHAGEAL BOUGIES
- Stryker EndoscopyJun 4, 1999
K983220 · STRYKER INFRAVISION ESOPHAGEAL KIT
- Medovations, Inc.Feb 2, 1998
K972119 · MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
- Gabriel Medical, Inc.Jun 27, 1996
K960173 · INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
- Telemed Systems, Inc.Jun 21, 1990
K901425 · PYLORIC BALLOON DILATOR
- Dacomed Corp.Jan 18, 1985
K843186 · ESKA MULTISTAGE ESOPHAGEAL BOUGIE
- Mill-Rose LaboratoryOct 2, 1984
K842679 · ESOPHAGEAL DILATOR SET
- Gaymar Industries, Inc.Jun 2, 1978
K780471 · GASTRIC LAVAGE KIT