Medical Device Manufacturer · US , Mchenry , IL

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

43 submissions · 43 cleared · Since 1976
43
Total
43
Cleared
0
Denied
43 devices
26-43 of 43
Cleared Feb 19, 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179 · FKX
Gastroenterology & Urology · 28d
Cleared Dec 03, 1981
MICROCOIL 80 DIALYZER
K812811 · FHS
Gastroenterology & Urology · 58d
Cleared Sep 16, 1981
MICROCOIL 150 DIALYZER
K811974 · FHS
Hematology · 65d
Cleared Apr 23, 1981
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · KPO
Gastroenterology & Urology · 17d
Cleared Apr 17, 1981
ERIKA EXTENSION SETS
K810823 · FJK
Gastroenterology & Urology · 24d
Cleared Apr 17, 1981
ERIKA HEPARIN INFUSION ADAPTOR
K810824 · FJK
Gastroenterology & Urology · 24d
Cleared May 14, 1980
MICRO-COIL 100 COIL DIALYZER
K800723 · FHS
Gastroenterology & Urology · 43d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · FJK
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · FJK
Gastroenterology & Urology · 52d
Cleared Sep 24, 1979
ERIKA HPF 100
K791320 · FJI
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
ERIKA HPF 200
K791321 · FJI
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
ERIKA HPF 300
K791322 · FJI
Gastroenterology & Urology · 74d
Cleared Feb 21, 1979
DIALYZER, MAGNIFLO 100 PARALLEL PLATE
K781966 · FJG
Gastroenterology & Urology · 89d
Cleared Aug 02, 1977
MODIFICATION TO KIDNEY DIALYZER
K771349 · FHS
Gastroenterology & Urology · 12d
Cleared Mar 30, 1977
ERIKA I.V. ADMINISTRATION SET
K770171 · FPA
General Hospital · 63d
Cleared Mar 08, 1977
NEEDLE, FISTULA, ERIKA
K770382 · KOC
Gastroenterology & Urology · 8d
Cleared Nov 19, 1976
ERI-FLO 900 DIALYZER
K760702 · FHS
Gastroenterology & Urology · 58d
Cleared Oct 27, 1976
DIALYZER (MODEL 1850)
K760374 · FHS
Gastroenterology & Urology · 83d
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