FDA 510(k) Applications Submitted by M J AERTS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
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