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

Endoscopic Cytology Brush

Regulation 876.1500

1510(k)s in 12 months (44 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
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Top companies in FDX

Company510(k)sRecalls
Hobbs Medical, Inc.24
Wilson-Cook Medical, Inc.50
United States Endoscopy Group, Inc.40
Cook Incorporated30
Annex Medical, Inc.20
Cox Medical Ent., Inc.20
Medical Device Technologies, Inc.20
Telemed Systems, Inc.20
Biosearch Medical Products, Inc.10
Boston Scientific Corp10
DateFirm and productCodeLinked 510(k)
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Medical Cytology Brush Catalog Number: 4206
Open, Classified		 FDXNone listed
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Medical Cytology Brush Catalog Number: 4204
Open, Classified		 FDXK182927
Mar 2, 2022Hobbs Medical, Inc.
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and rel
Open, Classified		 FDXK893729
May 1, 2018Hobbs Medical, Inc.
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cy
Terminated		 FDXK834402
Nov 16, 2006Ekos Corp
Lysus Transport Stand (infusion stand), part number 4896-003
Terminated		 FDXNone listed

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