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

System, Dialysate Delivery, Single Patient

Regulation 876.5820

0510(k)s in 12 months (50 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in FKP

Company510(k)sRecalls
Baxter Healthcare Corp33
Gambro, Inc.60
Cobe Laboratories, Inc.40
Extracorporeal Medical Specialities, Inc.40
Fresenius USA, Inc.40
Hach Co04
Nxstage Medical, Inc.40
Baxter Healthcare Renal Div03
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Cd Medical, Inc.30
DateFirm and productCodeLinked 510(k)
Aug 15, 2010Fresenius Medical Care North America
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
Terminated		 FKPK921456
Aug 15, 2010Fresenius Medical Care North America
Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Terminated		 FKPK921456
Apr 12, 2010Baxter Healthcare Renal Div
Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
Terminated		 FKPK883111
Sep 21, 2008Hach Co
HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bags containing 1/100-strip bottle, one medici
Terminated		 FKPK003615
Sep 21, 2008Hach Co
RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays p
Terminated		 FKPK003615
Sep 21, 2008Hach Co
HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. Th
Terminated		 FKPK003615
Sep 21, 2008Hach Co
HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles
Terminated		 FKPK003615
Apr 18, 2006Baxter Healthcare Renal Div
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated		 FKPK910215
Dec 2, 2004Baxter Healthcare Renal Div
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor
Terminated		 FKPK910215
May 15, 2003Baxter Healthcare Corp.
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor
Terminated		 FKPK910215
Mar 20, 2003Baxter Healthcare Corp.
Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated		 FKPK883111
Mar 20, 2003Baxter Healthcare Corp.
Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015
Terminated		 FKPK872364
K894838

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