Company ยท US
Terumo America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1981. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | 5 |
| FMI | Needle, Hypodermic, Single Lumen | 3 |
| FIE | Needle, Fistula | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 |
| FKJ | Filter, Blood, Dialysis | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| FMF | Syringe, Piston | 1 |
| FOX | Stand, Infusion | 1 |
| FPB | Filter, Infusion Line | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | 1 |
| HEK | Monitor, Heart Sound, Fetal, Ultrasonic | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
| KPE | Container, I.V. | 1 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 1981 | K811523 | PLASMA FLEX Terumo America, Inc. | KSR |
| Jan 22, 1981 | K802970 | TERUMO HOLLOW FIBER OXYGENATOR Terumo America, Inc. | DTZ |
| Dec 18, 1980 | K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Dec 18, 1980 | K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Aug 12, 1980 | K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Aug 12, 1980 | K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER Terumo America, Inc. | KDJ |
| Aug 12, 1980 | K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Nov 13, 1979 | K791411 | COAXIAL DUAL FLOW CATHETER Terumo America, Inc. | KOC |
| Jul 30, 1979 | K791173 | SURFLO INJECTION PLUG Terumo America, Inc. | FPA |
| May 24, 1979 | K790105 | TERUMO IMUGARD Terumo America, Inc. | GKT |
| Mar 17, 1978 | K772362 | AVF SET FOR SINGLE NEEDLE HEMODIALYSIS Terumo America, Inc. | FIE |
| Nov 28, 1977 | K772040 | TRANSDUCER PROTECTOR Terumo America, Inc. | FKJ |
| Sep 28, 1977 | K771432 | HICALIQ IVH BAG Terumo America, Inc. | KPE |
| Sep 28, 1977 | K771431 | ARTIFICIAL K-NOSE BREATHAID Terumo America, Inc. | |
| Sep 20, 1977 | K771693 | CLIRANS BLOOD LINES SET Terumo America, Inc. | FJK |
| Sep 20, 1977 | K771430 | BLOOD FILTER, W/SET Terumo America, Inc. | FPB |
| Sep 15, 1977 | K771694 | CLIRANS TH 15 HOLLOW FIBER DIALYZER Terumo America, Inc. | FJI |
| Sep 12, 1977 | K771212 | SAFEED DISP. PLASTIC CATHETER Terumo America, Inc. | KNY |
| Aug 26, 1977 | K771458 | INFUSION ACCELERATOR Terumo America, Inc. | KZD |
| Aug 16, 1977 | K771454 | MICRO SYRINGE & NEEDLE Terumo America, Inc. | |
| Jul 26, 1977 | K771209 | TERUFUSION BLOOD ADMIN. SET Terumo America, Inc. | FMI |
| Jul 15, 1977 | K771206 | AV FISTULA NEEDLE SET Terumo America, Inc. | FIE |
| Jul 14, 1977 | K771211 | DOPPLER (UTD-5 & UTD-6) Terumo America, Inc. | HEK |
| Jul 14, 1977 | K771207 | TERUFUSION DONOR SET Terumo America, Inc. | FMI |
| Jul 14, 1977 | K771205 | HYPODERMIC SYRINGE Terumo America, Inc. | FMF |
| Jul 14, 1977 | K771204 | SURFLO WINGED INFUSION SET Terumo America, Inc. | FPA |
| Jul 14, 1977 | K771203 | DISP. HYPODERMIC NEEDLE Terumo America, Inc. | FMI |
| Jul 11, 1977 | K771210 | UROGARD URINARY DRAINAGE BAG Terumo America, Inc. | FCN |
| Mar 16, 1977 | K770422 | CATHETER, SURFLO, I.V. Terumo America, Inc. | FOX |
| Dec 9, 1976 | K760948 | THERMO FINER CORETEMP Terumo America, Inc. | FLL |
| Nov 1, 1976 | K760775 | TERUMO DISPOSABLE SPINAL NEEDLE Terumo America, Inc. | GAA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||