Company ยท US
Gambro, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2009. Name variants (Inc, Corp, punctuation) are merged.
87510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 15 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 10 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 9 |
| FJG | Dialyzer, Parallel Flow | 7 |
| FKP | System, Dialysate Delivery, Single Patient | 6 |
| CBK | Ventilator, Continuous, Facility Use | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 2 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 |
| FHS | Dialyzer, Single Coil | 2 |
| FII | System, Dialysate Delivery, Sealed | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 |
| HRX | Arthroscope | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2009 | K083158 | EXALIS, SOFTWARE VERSION 1.15 Gambro, Inc. | KDI |
| Feb 1, 2008 | K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 Gambro | KDI |
| Nov 2, 2007 | K070643 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 Gambro, Inc. | KDI |
| Sep 15, 2003 | K032431 | PRISMA M60/M100 SETS Gambro, Inc. | KDI |
| Sep 28, 1990 | K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 Gambro, Inc. | FKP |
| Aug 30, 1990 | K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS Gambro, Inc. | FKP |
| Jul 27, 1990 | K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER Gambro, Inc. | FJI |
| Jul 16, 1990 | K900918 | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER Gambro, Inc. | KDI |
| May 11, 1989 | K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY Gambro, Inc. | FJI |
| Mar 15, 1989 | K890112 | ENGSTROM ELIZA + CO2 ANALYZER Gambro, Inc. | CCK |
| Feb 8, 1989 | K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER Gambro, Inc. | FJI |
| Sep 29, 1988 | K883589 | GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER Gambro, Inc. | FJI |
| Aug 24, 1988 | K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 Gambro, Inc. | FII |
| Mar 3, 1988 | K872482 | GAMBRO-ENGSTROM ERICA IV RESPIRATOR Gambro, Inc. | CBK |
| Feb 19, 1988 | K880084 | GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS Gambro, Inc. | FJI |
| Jan 27, 1988 | K880083 | GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS Gambro, Inc. | FJI |
| Dec 29, 1987 | K873643 | GAMBRO ADSORBA 150C Gambro, Inc. | FLD |
| Oct 26, 1987 | K873155 | GAMBRO BICART SYSTEM Gambro, Inc. | FKP |
| May 15, 1987 | K871108 | GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER Gambro, Inc. | KDI |
| Feb 20, 1987 | K864095 | ENGSTROM EDITH MODELS 500,1000,1500 & 1500F Gambro, Inc. | BYD |
| Nov 7, 1986 | K864094 | GAMBRO FLUID CONTROL MONITOR FCM 10-1 Gambro, Inc. | FKP |
| Nov 6, 1986 | K864083 | GAMBRO BICARBONATE MONITOR BCM 10-2 Gambro, Inc. | FKP |
| Sep 29, 1986 | K862840 | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N Gambro, Inc. | FJG |
| Sep 9, 1986 | K862716 | HEMOFILTRATION SYSTEM 10 Gambro, Inc. | FII |
| Aug 29, 1986 | K860682 | GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET Gambro, Inc. | CGA |
| Jun 18, 1986 | K862025 | ENGSTROM ERICA II RESPIRATOR Gambro, Inc. | CBK |
| May 30, 1986 | K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 Gambro, Inc. | DTW |
| Apr 7, 1986 | K860938 | GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS Gambro, Inc. | KDI |
| Jan 8, 1986 | K853406 | GAMBRO LUNDIA PRO 3 & 5 DIALYZER Gambro, Inc. | FJG |
| Dec 13, 1985 | K854309 | GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 Gambro, Inc. | KDI |
| Sep 16, 1985 | K852455 | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 Gambro, Inc. | KRI |
| Aug 16, 1985 | K852454 | CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM Gambro, Inc. | FLL |
| May 16, 1985 | K850621 | GAMBRO PLASMAFILTRATION SYSTEM Gambro, Inc. | LKN |
| Apr 9, 1985 | K851230 | GAMBRO PRESSURE MONITOR GUARDS Gambro, Inc. | FIB |
| Aug 10, 1984 | K842503 | GAMBRO PULSATILE MONITOR PLM 10-200 Gambro, Inc. | DWA |
| Apr 25, 1984 | K831404 | BLOOD MONITOR BMM 10-4 Gambro, Inc. | LLB |
| Apr 24, 1984 | K840720 | FIBER HEMOFILTERS FH55-FH77 & 88 Gambro, Inc. | KOJ |
| Apr 5, 1984 | K840645 | ENGSTROM ELIZA DUO CO2 & O2 ANALYZ Gambro, Inc. | CCL |
| Mar 23, 1984 | K840543 | BLOOD CONCENTRATOR 140 Gambro, Inc. | KDI |
| Feb 4, 1984 | K831784 | HEMOFILTRATION SYSTEM Gambro, Inc. | KDI |
| Oct 14, 1983 | K832894 | LUNDIA 10-2-L PARALLEL PLATE HEMODIALY Gambro, Inc. | KOC |
| Jul 18, 1983 | K831677 | HYPER-HYPOTHERMIA UNIT HYPO 10-200 Gambro, Inc. | DWC |
| Jun 24, 1983 | K831606 | GF-180-L HOLLOW FIBER HEMODIALYSIS Gambro, Inc. | KOC |
| Jun 8, 1983 | K830673 | CRAFON ARTHROSCOPY LINES Gambro, Inc. | HRX |
| May 27, 1983 | K831338 | LUNDIA 10-3-L PARALLEL FLOW DIALYZER Gambro, Inc. | KOC |
| Apr 27, 1983 | K830596 | ULTRAFILTRATION MONITOR UFM-10-2 Gambro, Inc. | KDI |
| Apr 12, 1983 | K830677 | BLOOD LINE SETS FOR HEMOFILTRATION Gambro, Inc. | FJK |
| Apr 6, 1983 | K830905 | LUNDIA 10-2-N PARALLEL FLOW DIALYZER Gambro, Inc. | KOC |
| Mar 8, 1983 | K823848 | CRAFTON ARTHROSCOPY PUMP AP-10 Gambro, Inc. | HRX |
| Mar 2, 1983 | K830284 | FH 101, FH 202 & FH 303 FIBER HEMOFILTER Gambro, Inc. | KDI |
Newest 50 of 87.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||