510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Neurent Medical Inc.

Galway Galway, IE

NEURENT MEDICAL INC. appears in FDA device records in Galway Galway, IE. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 4 510(k) clearances for Neurent Medical Inc. between 2021 and 2026. The busiest year on record is 2021, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Neurent Medical Inc., by decision year
YearClearances
20211
20221
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261833NEUROMARK System (NMK00301)GEISubstantially Equivalent
K250048NEUROMARK System (NMK00301)GEISubstantially Equivalent
K222032NEUROMARK SystemGEISubstantially Equivalent
K212666Neuromark SystemGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Neurent Medical Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30215591033021559103NEURENT MEDICAL INC.150 Grossman Drive, Suite 203, Braintree, MA 02184 US2026No device listings on this registration
30168136903016813690NEURENT MEDICAL LIMITEDNeurent Medical, No. 1 Oranpoint, Galway Galway(County) H91 D7X2 IE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Neurent Medical Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain