Terumo Europe N.V.
LEUVEN Vlaams Brabant, BE
TERUMO EUROPE N.V. appears in FDA device records in LEUVEN Vlaams Brabant, BE. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Terumo Europe N.V. between 1999 and 2025. The busiest year on record is 2007, with 4. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | FMI | Substantially Equivalent | |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | FMI | Substantially Equivalent | |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | FMI | Substantially Equivalent | |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | QYM | Substantially Equivalent | |
| K212095 | SurGuard3 Safety Hypodermic Needle | FMI | Substantially Equivalent | |
| K192057 | K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall | FMI | Substantially Equivalent | |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | FMF | Substantially Equivalent | |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | FMI | Substantially Equivalent | |
| K150263 | K-Pack II Needle-21G x 2 | FMI | Substantially Equivalent | |
| K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | |
| K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | |
| K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL | FMI | Substantially Equivalent | |
| K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE | FMI | Substantially Equivalent | |
| K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL | FMI | Substantially Equivalent | |
| K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE | FMI | Substantially Equivalent | |
| K100946 | INTRAVSCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K083514 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K082820 | K-PACK II NEEDLE - 29G THIN WALL | FMI | Substantially Equivalent | |
| K072894 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | |
| K070264 | 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB | FMF | Substantially Equivalent | |
| K070547 | SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | |
| K070362 | SURFLO WINGED INFUSION SET | FPA | Substantially Equivalent | |
| K062608 | 29G AND 30G K-PACK II NEEDLE | FMI | Substantially Equivalent | |
| K053413 | TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES | FMF | Substantially Equivalent | |
| K052887 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS | FPA | Substantially Equivalent | |
| K041358 | VENOJECT LUER ADAPTER | JKA | Substantially Equivalent | |
| K001572 | NEOLUS NEEDLE | FMI | Substantially Equivalent | |
| K984576 | K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681413 | 3001570557 | TERUMO EUROPE N.V. | INTERLEUVENLAAN 40, LEUVEN Vlaams Brabant 3001 BE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
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