Panels › Gastroenterology, Urology › Product code NHV · Class 2
System, Water Purification, General Medical Use
Regulation 876.5665
1510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NHV
| Company | 510(k)s | Recalls |
|---|---|---|
| Nephros, Inc. | 3 | 0 |
| Ecolab, Inc. | 2 | 0 |
| Pall International Sarl | 2 | 0 |
| Aqua-Tools | 1 | 0 |
| E.A.M Benelux B.V | 1 | 0 |
| Evoqua Water Technologies, LLC | 1 | 0 |
| I3 Membrane GmbH | 1 | 0 |
| Prismedical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2026 | K261470 | QF10 E.A.M Benelux B.V, NL | NHV |
| Jun 2, 2023 | K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) I3 Membrane GmbH, DE | NHV |
| Oct 25, 2019 | K191563 | FILTRAY 2G Disposable Water Filters Aqua-Tools, FR | NHV |
| Mar 29, 2019 | K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand Ecolab, Inc. | NHV |
| Jun 29, 2018 | K173164 | Ecolab POU Water Filter Ecolab, Inc. | NHV |
| Jun 1, 2017 | K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) Pall International Sarl, CH | NHV |
| Dec 22, 2016 | K161467 | HydraGuard 10 UltraFilter Nephros, Inc. | NHV |
| Oct 21, 2016 | K153784 | NOSOGARD FILTERS Evoqua Water Technologies, LLC | NHV |
| Jun 10, 2016 | K153434 | Pall-Aquasafe Water Filter Pall International Sarl, CH | NHV |
| Apr 8, 2016 | K153084 | Nephros S100 Nephros, Inc. | NHV |
| Oct 24, 2014 | K141731 | NEPHROS DSU-H, NEPHROS SSU-H Nephros, Inc. | NHV |
| May 7, 2002 | K012716 | MAINSTREAM WATER PURIFICATION DEVICE Prismedical Corp. | NHV |
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