Company ยท US
Gambro Healthcare
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2000. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 26, 2000 | K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER Gambro Healthcare | MSF |
| Jan 27, 2000 | K990039 | GAMBRO DQM 200 Gambro Healthcare | LFP |
| Apr 21, 1999 | K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS Gambro Healthcare | 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 4, 1998 | K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET Gambro Healthcare | KDI |
| Oct 21, 1998 | K982818 | HOSPAL TIPSTOP Gambro Healthcare | KMF |
| Sep 23, 1998 | K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H Gambro Healthcare | FIP |
| Aug 11, 1998 | K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Gambro Healthcare | KDI |
| May 18, 1998 | K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM Gambro Healthcare | FIP |
| Sep 26, 1997 | K970253 | COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET Gambro Healthcare | KDI |
| Sep 20, 1996 | K962427 | COBE CENTRYSYSTEM 700 HG HEMODIALYZER Gambro Healthcare | KDI |
| Aug 28, 1996 | K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) Gambro Healthcare | FKT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||