Medical Device Manufacturer · US , Mchenry , IL

Gambro, Inc. - FDA 510(k) Cleared Devices

86 submissions · 86 cleared · Since 1976
86
Total
86
Cleared
0
Denied
64 devices
26-50 of 64
Cleared Apr 25, 1984
BLOOD MONITOR BMM 10-4
K831404 · LLB
Gastroenterology & Urology · 359d
Cleared Mar 23, 1984
BLOOD CONCENTRATOR 140
K840543 · KDI
Gastroenterology & Urology · 44d
Cleared Feb 04, 1984
HEMOFILTRATION SYSTEM
K831784 · KDI
Gastroenterology & Urology · 247d
Cleared Oct 14, 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894 · KOC
Gastroenterology & Urology · 49d
Cleared Jun 24, 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606 · KOC
Gastroenterology & Urology · 37d
Cleared May 27, 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
K831338 · KOC
Gastroenterology & Urology · 32d
Cleared Apr 27, 1983
ULTRAFILTRATION MONITOR UFM-10-2
K830596 · KDI
Gastroenterology & Urology · 62d
Cleared Apr 12, 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · FJK
Gastroenterology & Urology · 39d
Cleared Apr 06, 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905 · KOC
Gastroenterology & Urology · 16d
Cleared Mar 02, 1983
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
K830284 · KDI
Gastroenterology & Urology · 34d
Cleared Jan 12, 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
K823791 · KOC
Gastroenterology & Urology · 27d
Cleared Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · KOC
Gastroenterology & Urology · 35d
Cleared May 28, 1982
GF-180-M & GF-180-H HEMODIALYZERS
K821367 · KOC
Gastroenterology & Urology · 18d
Cleared Apr 16, 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · FKQ
Gastroenterology & Urology · 25d
Cleared Mar 02, 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
K820304 · FJI
Gastroenterology & Urology · 26d
Cleared Aug 31, 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
K811944 · KDI
Gastroenterology & Urology · 55d
Cleared Jul 10, 1981
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · FIP
Gastroenterology & Urology · 25d
Cleared Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · KDJ
Gastroenterology & Urology · 32d
Cleared Feb 25, 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · FKR
Gastroenterology & Urology · 37d
Cleared Dec 22, 1980
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · FJG
Gastroenterology & Urology · 84d
Cleared Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
K802956 · FIE
Gastroenterology & Urology · 32d
Cleared Dec 18, 1980
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · KPF
Gastroenterology & Urology · 36d
Cleared Aug 27, 1980
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · KDI
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
K801480 · KDI
Gastroenterology & Urology · 64d
Cleared Jul 21, 1980
GF-120-L DIALYZER
K801370 · FJI
Gastroenterology & Urology · 41d
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