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
86 devices
26-50 of 86
Cleared May 30, 1986
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
K860076 · DTW
Cardiovascular · 142d
Cleared Apr 07, 1986
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
K860938 · KDI
Gastroenterology & Urology · 26d
Cleared Jan 08, 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · FJG
Gastroenterology & Urology · 149d
Cleared Dec 13, 1985
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · KDI
Gastroenterology & Urology · 49d
Cleared Sep 16, 1985
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · KRI
Cardiovascular · 98d
Cleared Aug 16, 1985
CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
K852454 · FLL
General Hospital · 67d
Cleared May 16, 1985
GAMBRO PLASMAFILTRATION SYSTEM
K850621 · LKN
Gastroenterology & Urology · 90d
Cleared Apr 09, 1985
GAMBRO PRESSURE MONITOR GUARDS
K851230 · FIB
Gastroenterology & Urology · 14d
Cleared Aug 10, 1984
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · DWA
Cardiovascular · 45d
Cleared Apr 25, 1984
BLOOD MONITOR BMM 10-4
K831404 · LLB
Gastroenterology & Urology · 359d
Cleared Apr 24, 1984
FIBER HEMOFILTERS FH55-FH77 & 88
K840720 · KOJ
Dental · 67d
Cleared Apr 05, 1984
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · CCL
Anesthesiology · 50d
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 Jul 18, 1983
HYPER-HYPOTHERMIA UNIT HYPO 10-200
K831677 · DWC
Cardiovascular · 56d
Cleared Jun 24, 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606 · KOC
Gastroenterology & Urology · 37d
Cleared Jun 08, 1983
CRAFON ARTHROSCOPY LINES
K830673 · HRX
Orthopedic · 96d
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 08, 1983
CRAFTON ARTHROSCOPY PUMP AP-10
K823848 · HRX
Orthopedic · 77d
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

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