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

System, Peritoneal, Automatic Delivery

Regulation 876.5630

0510(k)s in 12 months (83 all time)
0recalls in 12 months (53 all time)
51recalls that name a 510(k)
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Top companies in FKX

Company510(k)sRecalls
Baxter Healthcare Corp723
Baxter Healthcare Renal Div015
American Medical Products, Inc.110
Fresenius Medical Care Holdings, Inc.010
Fresenius Medical Care Renal Therapies Group, LLC63
Travenol Laboratories, S.A.80
Abbott Laboratories60
Medigroup50
Medionics International , Ltd.50
Quinton, Inc.40
DateFirm and productCodeLinked 510(k)
Jul 20, 2004Baxter Healthcare Renal Div
HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R,
Terminated		 FKXK923065
Feb 21, 2003Baxter Healthcare Corp.
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5
Terminated		 FKXK012988
Feb 21, 2003Baxter Healthcare Corp.
HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441,
Terminated		 FKXK012988

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