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

Subsystem, Proportioning

Regulation 876.5820

0510(k)s in 12 months (12 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in FKR

Company510(k)sRecalls
Nxstage Medical, Inc.510
Bd Becton Dickinson Vacutainer Systems Preanalytic10
Extracorporeal Medical Specialities, Inc.10
Gambro, Inc.10
Renal Systems, Inc.10
Sartorius Filters, Inc.10
Travenol Laboratories, S.A.10
Trimedyne, Inc.10
Decided510(k)Device and applicantCode
May 15, 2014K140571NXSTAGE PUREFLOW SL
Nxstage Medical, Inc.
FKR
Sep 19, 2011K111174NXSTAGE PUREFLOW SL
Nxstage Medical, Inc.
FKR
Oct 15, 2008K080919NXSTAGE PUREFLOW SL
Nxstage Medical, Inc.
FKR
Mar 31, 2006K060296NXSTAGE DIALYSATE PREPARATION MODULE
Nxstage Medical, Inc.
FKR
Mar 17, 2005K043436NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
Nxstage Medical, Inc.
FKR
Jun 4, 1985K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
Sartorius Filters, Inc.
FKR
Mar 20, 1985K850756AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
Travenol Laboratories, S.A.
FKR
Jun 16, 1981K810605CHEMATIC BICARBONATE DIALYSATE SYSTEM
Trimedyne, Inc.
FKR
Feb 25, 1981K810127GAMBRO BICARBONATE MODULE, BCM-10
Gambro, Inc.
FKR
Nov 12, 1980K802465BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
Renal Systems, Inc.
FKR
May 14, 1980K800772MOD. DM-357 BICARBONATE RETROFIT KIT
Extracorporeal Medical Specialities, Inc.
FKR
Oct 2, 1978K781303BIO-PRO UNIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
FKR

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