Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

53 results for "Fresenius Medical Care Renal Therapies Group, LLC"
25–48 of 53
Search insights Median review: 148d Cleared: 100% Top manufacturer: Fresenius Medical Care Renal Therapies Group, LLC Lead specialty: Gastroenterology & Urology
Cleared Dec 16, 2022
multiFiltratePRO System
K220281 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 318d
Cleared Oct 31, 2022
Fresenius Liberty Select Cycler
K222318 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Oct 27, 2022
2008T BlueStar Hemodailysis Machine
K222952 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 30d
Cleared May 12, 2022
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 267d
Cleared Apr 15, 2022
Lilliput APD System
K212522 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 247d
Cleared Dec 28, 2020
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K203062 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 80d
Cleared Sep 21, 2020
Optiflux F180NR Dialyzer
K192707 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 360d
Cleared Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and...
K201207 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 136d
Cleared May 08, 2020
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
K192209 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 268d
Cleared Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K192017 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 270d
Cleared Feb 24, 2020
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry...
K191474 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 265d
Cleared Feb 21, 2020
Novalung System
K191407 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 269d
Cleared Aug 23, 2019
Hemoflow F3 and F4 Dialyzers
K190459 · FJI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 178d
Cleared Jan 10, 2019
DIASAFEplusUS
K182367 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 132d
Cleared May 24, 2018
Fresenius Liberty Select Cycler
K181108 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 27d
Cleared May 21, 2018
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter...
K173593 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 181d
Cleared May 10, 2018
2008T BlueStar Hemodialysis Machine
K173972 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 132d
Cleared May 01, 2018
Liberty Cycler Set
K173718 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 147d
Cleared Feb 14, 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 78d
Cleared Jan 24, 2018
Cycler Drain Bag Set
K173363 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
K172238 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 141d
Cleared Sep 15, 2017
Fresenius Liberty Select Cycler
K171652 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 102d
Cleared May 18, 2017
bibag
K162716 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 231d
Cleared Apr 26, 2016
2008K2 Hemodialysis Machine
K153449 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d