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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
DateFirm and productCodeLinked 510(k)
Feb 1, 2011Stryker Endoscopy
Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560
Terminated		 FATK983220
Dec 28, 2010Stryker Endoscopy
Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
Terminated		 FATK983220

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