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Terumo Europe N.V.

28 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (K251447)Terumo Europe N.V.2025-07-08
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (K243309)Terumo Europe N.V.2025-05-29
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (K243581)Terumo Europe N.V.2025-04-04
Terumo Injection Filter Needle (NF-3013RBKE05M) (K230951)Terumo Europe N.V.2023-10-18
SurGuard3 Safety Hypodermic Needle (K212095)Terumo Europe N.V.2022-08-22
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 (K192057)Terumo Europe N.V.2019-10-11
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (K161606)Terumo Europe N.V.2017-02-10
K-Pack II Needle - 29G x 5/16 Thin Wall (K151398)Terumo Europe N.V.2015-06-25
K-Pack II Needle-21G x 2 (K150263)Terumo Europe N.V.2015-04-01
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (K133894)Terumo Europe N.V.2014-03-18
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K133867)Terumo Europe N.V.2014-02-05
K-PACK II NEEDLE - 27G X 3/4 THIN WALL (K132233)Terumo Europe N.V.2013-09-06
27 G X 1/2 K-PACK SURSHIELD NEEDLE (K111797)Terumo Europe N.V.2011-09-22
K-PACK II NEEDLE- 27G & 30G THIN WALL (K110850)Terumo Europe N.V.2011-06-09
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE (K110527)Terumo Europe N.V.2011-06-06
INTRAVSCULAR ADMINISTRATION SET (K100946)Terumo Europe N.V.2010-08-02
TERUMO SYRINGE WITH/WITHOUT NEEDLE (K083514)Terumo Europe N.V.2009-05-22
K-PACK II NEEDLE - 29G THIN WALL (K082820)Terumo Europe N.V.2008-10-23
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K072894)Terumo Europe N.V.2007-11-06
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB (K070264)Terumo Europe N.V.2007-05-29
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) (K070547)Terumo Europe N.V.2007-05-25
SURFLO WINGED INFUSION SET (K070362)Terumo Europe N.V.2007-05-07
29G AND 30G K-PACK II NEEDLE (K062608)Terumo Europe N.V.2006-09-15
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES (K053413)Terumo Europe N.V.2006-04-06
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS (K052887)Terumo Europe N.V.2005-12-08
VENOJECT LUER ADAPTER (K041358)Terumo Europe N.V.2004-05-28
NEOLUS NEEDLE (K001572)Terumo Europe N.V.2000-08-14
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K (K984576)Terumo Europe N.V.1999-06-14

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Every clearance here is in the API, with alerts when new ones post.