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FDA 510(k) Applications Submitted by Novo Nordisk Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K093109
10/01/2009
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
NOVO NORDISK INC.
K173479
11/13/2017
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
Novo Nordisk Inc.
K182387
09/04/2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk Inc.
K162602
09/19/2016
NovoPen Echo
Novo Nordisk Inc.
K210258
02/01/2021
NovoFine
Novo Nordisk Inc.
K231255
05/01/2023
NovoFine« Plus
Novo Nordisk Inc.
K202005
07/21/2020
NovoFine Plus 32G Tip x 4 mm
Novo Nordisk Inc.
K050106
01/18/2005
NOVOFINE AUTOCOVER 30G X 8MM
NOVO NORDISK INC.
K053470
12/14/2005
NOVOFINE 32G TIP
NOVO NORDISK INC.
K123766
12/07/2012
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
NOVO NORDISK INC.
K150874
04/01/2015
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
NOVO NORDISK INC.
K090111
01/16/2009
FLEXPEN NEEDLE
NOVO NORDISK INC.
K062500
08/25/2006
FLEXPEN NEEDLE
NOVO NORDISK INC.
K133738
12/09/2013
NOVOFINE PLUS 32G 4 MM
NOVO NORDISK INC.
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