Nephros, Inc.
Nephros, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2017, with 3 FDA device recalls on record.
Top product codes for Nephros, Inc.
FDA recalls by Nephros, Inc.
- Z-0487-2014 — Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
- Z-0490-2014 — Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
- Z-0488-2014 — 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nephros, Inc.
- K161304 — EndoPur Filter
- K161467 — HydraGuard 10 UltraFilter
- K153084 — Nephros S100
- K141731 — NEPHROS DSU-H, NEPHROS SSU-H
- K112314 — NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
- K110285 — NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
- K090885 — NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
- K050603 — OLPUR DIALYZER, MODEL HD 190
Data sourced from openFDA. This site is unofficial and independent of the FDA.