Terumo America, Inc.
Mchenry, IL, US
Terumo America, Inc. appears in FDA device records in Mchenry, IL. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Terumo America, Inc. between 1976 and 1981. The busiest year on record is 1977, with 18. The most recent is 1981, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 18 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 5 |
| 1981 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K811523 | PLASMA FLEX | KSR | Substantially Equivalent | |
| K802970 | TERUMO HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | KDJ | Substantially Equivalent | |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K791411 | COAXIAL DUAL FLOW CATHETER | KOC | Substantially Equivalent | |
| K791173 | SURFLO INJECTION PLUG | FPA | Substantially Equivalent | |
| K790105 | TERUMO IMUGARD | GKT | Substantially Equivalent | |
| K772362 | AVF SET FOR SINGLE NEEDLE HEMODIALYSIS | FIE | Substantially Equivalent | |
| K772040 | TRANSDUCER PROTECTOR | FKJ | Substantially Equivalent | |
| K771432 | HICALIQ IVH BAG | KPE | Substantially Equivalent | |
| K771431 | ARTIFICIAL K-NOSE BREATHAID | Substantially Equivalent | ||
| K771693 | CLIRANS BLOOD LINES SET | FJK | Substantially Equivalent | |
| K771430 | BLOOD FILTER, W/SET | FPB | Substantially Equivalent | |
| K771694 | CLIRANS TH 15 HOLLOW FIBER DIALYZER | FJI | Substantially Equivalent | |
| K771212 | SAFEED DISP. PLASTIC CATHETER | KNY | Substantially Equivalent | |
| K771458 | INFUSION ACCELERATOR | KZD | Substantially Equivalent | |
| K771454 | MICRO SYRINGE & NEEDLE | Substantially Equivalent | ||
| K771209 | TERUFUSION BLOOD ADMIN. SET | FMI | Substantially Equivalent | |
| K771206 | AV FISTULA NEEDLE SET | FIE | Substantially Equivalent | |
| K771211 | DOPPLER (UTD-5 & UTD-6) | HEK | Substantially Equivalent | |
| K771207 | TERUFUSION DONOR SET | FMI | Substantially Equivalent | |
| K771205 | HYPODERMIC SYRINGE | FMF | Substantially Equivalent | |
| K771204 | SURFLO WINGED INFUSION SET | FPA | Substantially Equivalent | |
| K771203 | DISP. HYPODERMIC NEEDLE | FMI | Substantially Equivalent | |
| K771210 | UROGARD URINARY DRAINAGE BAG | FCN | Substantially Equivalent | |
| K770422 | CATHETER, SURFLO, I.V. | FOX | Substantially Equivalent | |
| K760948 | THERMO FINER CORETEMP | FLL | Substantially Equivalent | |
| K760775 | TERUMO DISPOSABLE SPINAL NEEDLE | GAA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KNYAccessories, Catheter, G-U
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- KPEContainer, I.V.
- FLLContinuous Measurement Thermometer
- FJIDialyzer, Capillary, Hollow Fiber
- FKJFilter, Blood, Dialysis
- FPBFilter, Infusion Line
- KZDInfusor, Pressure, For I.V. Bags
- HEKMonitor, Heart Sound, Fetal, Ultrasonic
- GAANeedle, Aspiration And Injection, Disposable
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- DTZOxygenator, Cardiopulmonary Bypass
- GKTSeparator, Automated, Blood Cell, Diagnostic
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FPASet, Administration, Intravascular
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FOXStand, Infusion
- FMFSyringe, Piston
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain