Medical Device Manufacturer · US , Mchenry , IL

Terumo America, Inc.

31 submissions · 31 cleared · Since 1976
31
Total
31
Cleared
0
Denied

Terumo America, Inc. — FDA 510(k) Submissions

Terumo America, Inc. has submitted 31 FDA 510(k) premarket notifications since 1976, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, Capillary, Hollow Fiber, Needle, Hypodermic, Single Lumen, Set, Administration, Intravascular, Needle, Fistula, Urinary Drainage Collection Kit, For Indwelling Catheter . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
PLASMA FLEX
K811523 · KSR Container, Empty, For... · Chemistry
Sep 1981 103d
TERUMO HOLLOW FIBER OXYGENATOR
K802970 · DTZ Oxygenator,... · Cardiovascular
Jan 1981 62d
CLIRANS TH13 HOLLOW FIBER DIALYZER
K802122 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Dec 1980 105d
CLIRANS TH10 HOLLOW FIBER DIALYZER
K802441 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Dec 1980 72d
CLIRANS TE10 HOLLOW FIBER DIALYZER
K801192 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Aug 1980 85d
CLIRANS TE15 HOLLOW FIBER DIALYZER
K801193 · KDJ Set, Administration, For... · Gastroenterology & Urology
Aug 1980 85d
CLIRANS TE07 HOLLOW FIBER DIALYZER
K801194 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Aug 1980 85d
COAXIAL DUAL FLOW CATHETER
K791411 · KOC Accessories, Blood... · Gastroenterology & Urology
Nov 1979 109d
SURFLO INJECTION PLUG
K791173 · FPA Set, Administration,... · General Hospital
Jul 1979 35d
TERUMO IMUGARD
K790105 · GKT Separator, Automated,... · Hematology
May 1979 128d
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
K772362 · FIE Needle, Fistula · Gastroenterology & Urology
Mar 1978 80d
TRANSDUCER PROTECTOR
K772040 · FKJ Filter, Blood, Dialysis · Hematology
Nov 1977 31d
ARTIFICIAL K-NOSE BREATHAID
K771431 · Cardiovascular
Sep 1977 58d
HICALIQ IVH BAG
K771432 · KPE Container, I.v. · General Hospital
Sep 1977 58d
BLOOD FILTER, W/SET
K771430 · FPB Filter, Infusion Line · General Hospital
Sep 1977 50d
CLIRANS BLOOD LINES SET
K771693 · FJK Set, Tubing, Blood, With... · Hematology
Sep 1977 14d
CLIRANS TH 15 HOLLOW FIBER DIALYZER
K771694 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Sep 1977 9d
SAFEED DISP. PLASTIC CATHETER
K771212 · KNY Accessories, Catheter, G-u · Gastroenterology & Urology
Sep 1977 69d
INFUSION ACCELERATOR
K771458 · KZD Infusor, Pressure, For... · General Hospital
Aug 1977 22d
MICRO SYRINGE & NEEDLE
K771454 · Chemistry
Aug 1977 12d
TERUFUSION BLOOD ADMIN. SET
K771209 · FMI Needle, Hypodermic,... · General Hospital
Jul 1977 21d
AV FISTULA NEEDLE SET
K771206 · FIE Needle, Fistula · Gastroenterology & Urology
Jul 1977 10d
DISP. HYPODERMIC NEEDLE
K771203 · FMI Needle, Hypodermic,... · General Hospital
Jul 1977 9d
SURFLO WINGED INFUSION SET
K771204 · FPA Set, Administration,... · General Hospital
Jul 1977 9d
HYPODERMIC SYRINGE
K771205 · FMF Syringe, Piston · General Hospital
Jul 1977 9d
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