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Panels › Gastroenterology, Urology › Product code FAT · Class 2

Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

Regulation 876.5365

0510(k)s in 12 months (8 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in FAT

Company510(k)sRecalls
Stryker Endoscopy12
Dacomed Corp.10
Gabriel Medical, Inc.10
Gaymar Industries, Inc.10
Medovations, Inc.10
Mill-Rose Laboratory10
Teleflexmedical, Inc.10
Telemed Systems, Inc.10
Decided510(k)Device and applicantCode
Jun 16, 2014K133439PILLING ESOPHAGEAL BOUGIES
Teleflexmedical, Inc.
FAT
Jun 4, 1999K983220STRYKER INFRAVISION ESOPHAGEAL KIT
Stryker Endoscopy
FAT
Feb 2, 1998K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
Medovations, Inc.
FAT
Jun 27, 1996K960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
Gabriel Medical, Inc.
FAT
Jun 21, 1990K901425PYLORIC BALLOON DILATOR
Telemed Systems, Inc.
FAT
Jan 18, 1985K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIE
Dacomed Corp.
FAT
Oct 2, 1984K842679ESOPHAGEAL DILATOR SET
Mill-Rose Laboratory
FAT
Jun 2, 1978K780471GASTRIC LAVAGE KIT
Gaymar Industries, Inc.
FAT

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