Medical Device Manufacturer · US , Oklahoma City , OK

Gambro Healthcare - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1996
13
Total
13
Cleared
0
Denied

Gambro Healthcare has 13 FDA 510(k) cleared gastroenterology & urology devices. Based in Oklahoma City, US.

Historical record: 13 cleared submissions from 1996 to 2000.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Gambro Healthcare

13 devices
1-13 of 13
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gastroenterology & Urology · 303d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · LFP
Chemistry · 386d
Cleared Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · KDI
Gastroenterology & Urology · 282d
Cleared Mar 26, 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · KDI
Gastroenterology & Urology · 256d
Cleared Feb 24, 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...
K980386 · KDI
Gastroenterology & Urology · 387d
Cleared Nov 04, 1998
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
K982760 · KDI
Gastroenterology & Urology · 90d
Cleared Oct 21, 1998
HOSPAL TIPSTOP
K982818 · KMF
General & Plastic Surgery · 71d
Cleared Sep 23, 1998
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K974899 · FIP
Gastroenterology & Urology · 267d
Cleared Aug 11, 1998
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K981681 · KDI
Gastroenterology & Urology · 90d
Cleared May 18, 1998
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · FIP
Gastroenterology & Urology · 54d
Cleared Sep 26, 1997
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
K970253 · KDI
Gastroenterology & Urology · 247d
Cleared Sep 20, 1996
COBE CENTRYSYSTEM 700 HG HEMODIALYZER
K962427 · KDI
Gastroenterology & Urology · 88d
Cleared Aug 28, 1996
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE...
K954623 · FKT
Gastroenterology & Urology · 328d
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