Company · BE
Terumo Europe N.V.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2025. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2025 | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) Terumo Europe N.V., BE | FMI |
| May 29, 2025 | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) Terumo Europe N.V., BE | FMI |
| Apr 4, 2025 | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) Terumo Europe N.V., BE | FMI |
| Oct 18, 2023 | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) Terumo Europe N.V., BE | QYM |
| Aug 22, 2022 | K212095 | SurGuard3 Safety Hypodermic Needle Terumo Europe N.V., BE | FMI |
| Oct 11, 2019 | 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 Terumo Europe N.V., BE | FMI |
| Feb 10, 2017 | K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH Terumo Europe N.V., BE | FMF |
| Jun 25, 2015 | K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall Terumo Europe N.V., BE | FMI |
| Apr 1, 2015 | K150263 | K-Pack II Needle-21G x 2 Terumo Europe N.V., BE | FMI |
| Mar 18, 2014 | K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| Feb 5, 2014 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| Sep 6, 2013 | K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL Terumo Europe N.V., BE | FMI |
| Sep 22, 2011 | K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE Terumo Europe N.V., BE | FMI |
| Jun 9, 2011 | K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL Terumo Europe N.V., BE | FMI |
| Jun 6, 2011 | K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE Terumo Europe N.V., BE | FMI |
| Aug 2, 2010 | K100946 | INTRAVSCULAR ADMINISTRATION SET Terumo Europe N.V., BE | FPA |
| May 22, 2009 | K083514 | TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Europe N.V., BE | FMF |
| Oct 23, 2008 | K082820 | K-PACK II NEEDLE - 29G THIN WALL Terumo Europe N.V., BE | FMI |
| Nov 6, 2007 | K072894 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| May 29, 2007 | K070264 | 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB Terumo Europe N.V., BE | FMF |
| May 25, 2007 | K070547 | SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| May 7, 2007 | K070362 | SURFLO WINGED INFUSION SET Terumo Europe N.V., BE | FPA |
| Sep 15, 2006 | K062608 | 29G AND 30G K-PACK II NEEDLE Terumo Europe N.V., BE | FMI |
| Apr 6, 2006 | K053413 | TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES Terumo Europe N.V., BE | FMF |
| Dec 8, 2005 | K052887 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS Terumo Europe N.V., BE | FPA |
| May 28, 2004 | K041358 | VENOJECT LUER ADAPTER Terumo Europe N.V. | JKA |
| Aug 14, 2000 | K001572 | NEOLUS NEEDLE Terumo Europe N.V., BE | FMI |
| Jun 14, 1999 | 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 Terumo Europe N.V., BE | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||