Panels › Gastroenterology, Urology › Product code KDI · Class 2
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation 876.5860
7510(k)s in 12 months (346 all time)
11recalls in 12 months (217 all time)
192recalls that name a 510(k)
Top companies in KDI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 2000 | K992563 | A-22 HEMODIALYZER Althin Medical AB, SE | KDI |
| Dec 7, 1999 | K990643 | PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Nov 24, 1999 | K992894 | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 Baxter Healthcare Corp | KDI |
| Oct 6, 1999 | K993064 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Gambro Renal Care Products | KDI |
| Sep 3, 1999 | K982926 | FRESENIUS BLOOD VOLUME MONITOR Fresenius Medical Care North America | KDI |
| Aug 4, 1999 | K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS Fresenius USA, Inc. | KDI |
| Jul 30, 1999 | K991520 | FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION Fresenius Medical Care North America | KDI |
| Apr 21, 1999 | K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS Gambro Healthcare | KDI |
| Apr 14, 1999 | K982134 | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 Dynamic Technology Corp., TW | KDI |
| Mar 26, 1999 | K982414 | GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS Gambro Healthcare | KDI |
| Feb 24, 1999 | K980386 | HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) Gambro Healthcare | KDI |
| Nov 13, 1998 | K983085 | HEMOCOR HPH 700 HEMOCONCENTRATOR Minntech Corp. | KDI |
| Nov 10, 1998 | K973322 | DIAPACT CRRT B.Braun Medical, Inc. | KDI |
| Nov 4, 1998 | K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET Gambro Healthcare | KDI |
| Aug 11, 1998 | K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Gambro Healthcare | KDI |
| Jul 10, 1998 | K974652 | BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER Baxter Healthcare Corp | KDI |
| Jun 26, 1998 | K963440 | DIALOG DIALYSIS MACHINE B. Braun Medical AG | KDI |
| May 19, 1998 | K980656 | PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 Baxter Healthcare Corp | KDI |
| May 14, 1998 | K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS Fresenius USA, Inc. | KDI |
| May 12, 1998 | K980859 | HEMOCOR HPH MINI HEMOCONCENTRATOR Minntech Corp. | KDI |
| Jan 30, 1998 | K973516 | CAPIOX HEMOCONCENTRATOR Terumo Medical Corp. | KDI |
| Sep 26, 1997 | K970253 | COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET Gambro Healthcare | KDI |
| Sep 9, 1997 | K970591 | BLOOD MONITOR PUMP Baxter Healthcare Corp | KDI |
| Jul 24, 1997 | K971180 | BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT C.R. Bard, Inc. | KDI |
| Jul 8, 1997 | K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK Research Medical, Inc. | KDI |
| Jul 3, 1997 | K961465 | 2008H ON LINE CLEARANCE MONITOR Fresenius USA, Inc. | KDI |
| Jun 2, 1997 | K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl | KDI |
| May 21, 1997 | K964922 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Apr 30, 1997 | K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Apr 18, 1997 | K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Mar 25, 1997 | K963203 | BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT Baxter Healthcare Corp | KDI |
| Mar 19, 1997 | K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS NIKKISO CO., LTD. | KDI |
| Feb 10, 1997 | K946279 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Cobe Renal Care, Inc. | KDI |
| Jan 10, 1997 | K955384 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Oct 9, 1996 | K962707 | MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET Minntech Corp. | KDI |
| Sep 20, 1996 | K962427 | COBE CENTRYSYSTEM 700 HG HEMODIALYZER Gambro Healthcare | KDI |
| Aug 14, 1996 | K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Aug 8, 1996 | K954987 | ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Jan 11, 1996 | K951311 | GAMBRO HC 14R HEMOCONCENTRATOR Cobe Renal Care, Inc. | KDI |
| Oct 5, 1995 | K952983 | ALTR NOVA 110 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Oct 5, 1995 | K952982 | ALTREX 110 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Oct 5, 1995 | K952978 | ALTRA FLUX 110 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
| Sep 15, 1995 | K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Sep 8, 1995 | K945747 | GAMBRO LUNDIA 94-600 DIALYZER Cobe Renal Care, Inc. | KDI |
| Aug 15, 1995 | K951344 | RMI HEMOCONCENTRATOR Research Medical, Inc. | KDI |
| Jun 22, 1995 | K942681 | FILTRYZER Toray Industries (America), Inc., JP | KDI |
| May 30, 1995 | K945625 | ALTRA NOVA(TM) 140 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
| May 30, 1995 | K945621 | ALTRA NOVA(TM) 170 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
| May 23, 1995 | K945542 | ALTRA FLUX(TM) 170 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
| May 18, 1995 | K945620 | ALTRA FLUX(TM) 140 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | KDI |
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