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

Subsystem, Water Purification

Regulation 876.5665

1510(k)s in 12 months (117 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
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Top companies in FIP

Company510(k)sRecalls
AmeriWater, LLC102
Fresenius Medical Care Holdings, Inc.08
Mar Cor Purification, Inc.43
Better Water, Inc.40
Fresenius Medical Care Renal Therapies Group, LLC40
Dayton Water Systems30
Gambro Renal Products30
Minntech Corp.30
Nephros, Inc.30
Usfilter/Ionpure, Inc.30
DateFirm and productCodeLinked 510(k)
Jun 13, 2024Fresenius Medical Care Holdings, Inc.
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Open, Classified		 FIPK143617
Apr 7, 2023Outset Medical, Inc.
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis
Open, Classified		 FIPK190793
K211370
Sep 19, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Open, Classified		 FIPK143617
Sep 19, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Open, Classified		 FIPK143617
Jul 25, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Open, Classified		 FIPK143617
Jul 25, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Open, Classified		 FIPK143617
Aug 3, 2021Fresenius Medical Care Holdings, Inc.
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Terminated		 FIPK133829
Mar 18, 2021Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water u
Terminated		 FIPK133829
Sep 1, 2020Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or
Terminated		 FIPK133829
May 6, 2014Mar Cor Purification
Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple pa
Terminated		 FIPK974899
Mar 14, 2014Mar Cor Purification
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water throug
Terminated		 FIPK110578
Mar 13, 2014Mar Cor Purification
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
Terminated		 FIPK974899
Sep 6, 2012AmeriWater Inc
AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems
Terminated		 FIPK111740
May 6, 2005U.S. Filter/Ionpure, Inc.
MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
Terminated		 FIPK030652
Oct 5, 2004Ameriwater Inc
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
Terminated		 FIPK922695

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