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

Colonoscope And Accessories, Flexible/Rigid

Regulation 876.1500

5510(k)s in 12 months (115 all time)
0recalls in 12 months (25 all time)
25recalls that name a 510(k)
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Top companies in FDF

Company510(k)sRecalls
Pentax Precision Instrument Corp.110
Aizu Olympus Co., Ltd.16
Motus GI Medical Technologies , Ltd.70
Olympus Medical Systems Corp.70
Olympus Corporation of the Americas07
Pentax of America, Inc.25
Avantis Medical Systems, Inc.60
Lumendi, LLC60
Fujifilm Corporation50
Fujifilm Medical Systems U.S.A, Inc.50
Decided510(k)Device and applicantCode
Mar 7, 1996K954704VS-200 VIDEO SIGMOIDOSCOPE
Welch Allyn, Inc.
FDF
Jun 27, 1995K951580FC-38LH, FIBER COLONOSCCOPE
Pentax Precision Instrument Corp.
FDF
Jun 27, 1995K951578FC-38LX, FIBER COLONOSCOPE
Pentax Precision Instrument Corp.
FDF
Jun 27, 1995K951575FC-38TLH, FIBER COLONOSCOPE
Pentax Precision Instrument Corp.
FDF
Feb 3, 1995K943895VISION SYSTEM COLONSCOPE
Vision-Sciences, Inc.
FDF
Jun 29, 1990K901610SULLIVAN VARIABLE STIFFNESS CABLE
Wilson-Cook Medical, Inc.
FDF
Mar 17, 1989K884857COLONOSCOPE GUIDING TUBE DEVICE
Mill-Rose Laboratory
FDF
Oct 22, 1982K822846PENTAX FC-38LA & FC-38SA COLONOFIBER
Pentax Precision Instrument Corp.
FDF
Apr 3, 1981K810682PENTAX COLONOSCOPE MODEL FC-34LA
Pentax Precision Instrument Corp.
FDF
Mar 31, 1981K810791PENTAX COLONOSCOPE MODEL FC-34 MA
Pentax Precision Instrument Corp.
FDF
Mar 27, 1981K810654STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
First Industries, Inc.
FDF
Jun 9, 1980K801223PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
Pentax Precision Instrument Corp.
FDF
Dec 6, 1979K792179AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
American Optical Corp.
FDF
Apr 4, 1979K790338COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
American Optical Corp.
FDF
Aug 30, 1976K760452COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
American Cystocope Makers, Inc.
FDF

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