Data / Medical devices / United States / Novo Nordisk Inc.
Novo Nordisk Inc.: FDA-registered device maker in Plainsboro, NJ, United States, 9 510(k) clearances
Novo Nordisk Inc. is registered with the FDA (registration 2244771) in Plainsboro, NJ, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 25, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2244771
- Address
- 800 Scudders Mill Rd, Plainsboro, NJ, United States, 08536
- Owner or operator
- NOVO NORDISK INC. (9027307)
- Roles
- Complaint file establishment
- First device listed
- November 27, 2006
- Registered through
- 2026
- Brand names listed
- Administration Set, FLEXPRO PENMATE, NOVOFINE 32G Tip, NOVOFINE AUTOCOVER 30G, NovoFine 32G Tip, NovoFine® 30G, NovoFine® 31G, NovoFine® 32G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| I.V. Start Kit | LRS | 2 | Complaint file establishment | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2023 | K231255 | NovoFine® Plus | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| June 23, 2021 | K210258 | NovoFine | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| December 19, 2020 | K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| December 17, 2018 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| January 17, 2018 | K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| May 21, 2014 | K133738 | NOVOFINE PLUS 32G 4 MM | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| June 18, 2010 | K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| February 1, 2010 | K090111 | FLEXPEN NEEDLE | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
| March 30, 2005 | K050106 | NOVOFINE AUTOCOVER 30G X 8MM | FMI | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 5, 2017 | 77704 | Class II | Terminated | Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. Th | A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Introducer, Syringe Needle
- All makers of I.V. Start Kit
Updated August 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.