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

Koelis

MEYLAN Isere, FR

KOELIS appears in FDA device records in MEYLAN Isere, FR. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. 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
7
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Koelis between 2010 and 2018. The busiest year on record is 2017, with 2. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Koelis, by decision year
YearClearances
20101
20131
20141
20161
20172
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K180970Disposable guides KDNG00ITXSubstantially Equivalent
K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeITXSubstantially Equivalent
K170521TRINITY/3D PROSTATE SUITEIYNSubstantially Equivalent
K160357TRINITYIYNSubstantially Equivalent
K141334REUSABLE GUIDEITXSubstantially Equivalent
K1314483D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTIONLLZSubstantially Equivalent
K100793UROSTATION 3D PROSTATE SUITELLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Koelis, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30084877083008487708KOELISBuilding D, MEYLAN Isere 38240 FR2026

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 Koelis 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