FDA 510(k) Applications Submitted by Terumo Europe N.V.

FDA 510(k) Number Submission Date Device Name Applicant
K212095 07/06/2021 SurGuard3 Safety Hypodermic Needle Terumo Europe N.V.
K150263 02/04/2015 K-Pack II Needle-21G x 2 TERUMO EUROPE N.V.
K070362 02/07/2007 SURFLO WINGED INFUSION SET TERUMO EUROPE N.V.
K001572 05/22/2000 NEOLUS NEEDLE TERUMO EUROPE N.V.
K082820 09/25/2008 K-PACK II NEEDLE - 29G THIN WALL TERUMO EUROPE N.V.
K984576 12/23/1998 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.
K110527 02/24/2011 K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE TERUMO EUROPE N.V.
K151398 05/26/2015 K-Pack II Needle - 29G x 5/16 Thin Wall TERUMO EUROPE N.V.
K192057 08/01/2019 K-Pack II Needle - 27G x 1/2ö Extra Thin Wall, K-Pack II Needle - 27G x 1/2ö Ultra Thin Wall, K-Pack II Needle - 30G x 1/2ö Extra Thin Wall, K-Pack II Needle - 30G x 1/2ö Ultra Thin Wall Terumo Europe N.V.
K070264 01/29/2007 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB TERUMO EUROPE N.V.
K070547 02/26/2007 SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V.
K110850 03/28/2011 K-PACK II NEEDLE- 27G & 30G THIN WALL TERUMO EUROPE N.V.
K100946 04/06/2010 INTRAVSCULAR ADMINISTRATION SET TERUMO EUROPE N.V.
K161606 06/10/2016 Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH TERUMO EUROPE N.V.
K111797 06/24/2011 27 G X 1/2 K-PACK SURSHIELD NEEDLE TERUMO EUROPE N.V.
K132233 07/18/2013 K-PACK II NEEDLE - 27G X 3/4 THIN WALL TERUMO EUROPE N.V.
K062608 09/05/2006 29G AND 30G K-PACK II NEEDLE TERUMO EUROPE N.V.
K072894 10/11/2007 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V.
K052887 10/13/2005 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS TERUMO EUROPE N.V.
K083514 11/26/2008 TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO EUROPE N.V.
K053413 12/07/2005 TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES TERUMO EUROPE N.V.
K133867 12/20/2013 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V.
K133894 12/20/2013 SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V.
K041358 05/21/2004 VENOJECT LUER ADAPTER TERUMO EUROPE N.V.


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