ClearanceBrief
Panels › Gastroenterology, Urology › Product code FIB · Class 2

Protector, Transducer, Dialysis

Regulation 876.5820

0510(k)s in 12 months (35 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in FIB

Company510(k)sRecalls
Filtertek, Inc.50
Medisystems Corp.30
Nipro Medical Corp.30
Fresenius Medical Care North America20
Mediflex Intl.20
Akcess Medical Products, Inc.10
Arbo Medical, Inc.10
Bain Medical Equipment (Guangzhou) Co., Ltd.10
Bipore, Inc.10
Circulatory Technology, Inc.10
Decided510(k)Device and applicantCode
Jun 28, 2024K240164NovaLine SP-C35 Transducer Protector (956007)
Bain Medical Equipment (Guangzhou) Co., Ltd., CN
FIB
Feb 21, 2008K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
Nipro Medical Corporation
FIB
May 24, 2001K001971HEMODIALYSIS TUBING SETS
Ofi Biomedica S.P.A.
FIB
Apr 27, 2001K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
Nipro Medical Corp.
FIB
Dec 5, 2000K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
Nipro Medical Corp.
FIB
Dec 1, 2000K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
Fresenius Medical Care North America
FIB
Jun 7, 2000K000702BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
Fresenius Medical Care North America
FIB
Nov 25, 1998K983076MEDISYSTEMS TRANSDUCER PROTECTOR
Medisystems Corp.
FIB
May 23, 1997K964337BETTER-BLADDER (BB)
Circulatory Technology, Inc.
FIB
May 12, 1997K970536MEDISYSTEMS TRANDUCER PROTECTOR
Medisystems Corp.
FIB
Apr 21, 1994K934069MILLEX, DUALEX (PLUS, ULTRA)
Millipore Corp.
FIB
Jan 14, 1994K925978MPC-80 TRANSDUCER
Molded Products, Inc.
FIB
Jul 1, 1992K915593TRANSDUCER PROTECTOR
United Pharmaceutical and Medical Supply Co.
FIB
Aug 30, 1991K912394TRANSDUCER PROTECTOR
Filtertek, Inc.
FIB
Aug 12, 1991K911658DIALYSIS TRANDSDUCER PROTECTOR
Tico Medical Instruments, Inc.
FIB
Aug 12, 1991K910821TRANSDUCER PROTECTOR
Gelman Sciences, Inc.
FIB
Jan 4, 1991K904912TRANSDUCER PROTECTOR
Filtertek, Inc.
FIB
Sep 12, 1990K902788CLEM TM
Arbo Medical, Inc.
FIB
Jul 27, 1990K901409TRANSDUCER PROTECTOR
Filtertek, Inc.
FIB
Jun 1, 1990K901996FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR
Filtertek, Inc.
FIB
May 15, 1990K900841HEMODIALYSIS TRANSDUCER PROTECTOR
Mediflex Intl.
FIB
Nov 24, 1989K895856MEDISYSTEMS TRANSDUCER PROTECTOR
Medisystems Corp.
FIB
Nov 8, 1989K895281TRANSDUCER PROTECTOR
Filtertek, Inc.
FIB
Apr 7, 1989K891752DA-46 FLUID BARRIER
Akcess Medical Products, Inc.
FIB
Mar 3, 1987K870394HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
Clinical Connections, Inc.
FIB
Sep 23, 1986K863496MEDIFLEX TRANSDUCER PROTECTOR
Mediflex Intl.
FIB
Jul 22, 1986K862015O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER
Bipore, Inc.
FIB
May 23, 1985K851734OMNIMED SUPERIOR TRANSDUCER PROTECTOR
Omni Intl., Inc.
FIB
May 21, 1985K851428TRANDUCER PROTECTOR
Galvin Industries, Inc.
FIB
Apr 9, 1985K851230GAMBRO PRESSURE MONITOR GUARDS
Gambro, Inc.
FIB
Jun 23, 1982K821268TRANSDUCER FILTER
Cp Medical
FIB
Sep 24, 1981K812162HEMODIALYSIS TRANSDUCER PROTECTOR
Membrana
FIB
Aug 20, 1981K812107RENALAB TRANSDUCER PROTECTOR, .22 MICRON
Renalab
FIB
Aug 7, 1981K811859BACTASHIELD
Tri-Med, Inc.
FIB
Jul 31, 1981K811892CORDIS DOW SERA FLO TM TRANSDUCER PROT
Cordis Corp.
FIB

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