Maker —
No US authorization
Decision—Studies450Trials49
Ellansé — no US marketing authorization found
Maker — · Injectables
No US authorization
PathwayPathwayThe FDA device, PMA and drug records were searched for this brand and for its manufacturer, and no record carries it. This is a checked absence, not an unchecked one: the queries that were run are listed on the product's page. It is a statement about the US record on the run date. It is not a safety finding, and it says nothing about the product's status in any other country.
Methodology →No US authorization
Methodology →No US authorization
ClassClassNo US record carries this brand, so there is no product code to read a device class from.
Methodology →—
Methodology →—
First decision—
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →—
Methodology →—
StudiesStudiesPubMed records for a fixed query about the MODALITY, not the brand. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →—
Methodology →—
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies.
Methodology →—
Methodology →—
No US authorization found — the records were searched, not left unchecked. What this measuresThe FDA device, PMA and drug records were searched for this brand and for its manufacturer, and no record carries it. This is a checked absence, not an unchecked one: the queries that were run are listed on the product's page. It is a statement about the US record on the run date. It is not a safety finding, and it says nothing about the product's status in any other country. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically.
Methodology →
Overview
- Modality
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- Manufacturer
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- Category
- Injectables
- Latest decision
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- FDA records
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- Mapping
- Not verified
Mapping is the weakest link on this page; the rule is published. What this measuresSearched openFDA for a PMA or 510(k) record under this trade name and under the manufacturer's name; both trade-name searches returned NOT_FOUND and the applicant searches returned only unrelated Sinclair Pharmaceuticals oral/wound products. No US regulatory number is assigned. Absence of a record here is not proof of anything beyond: openFDA has no matching record on the run date. Re-checked on the current run date: the 510(k), PMA and drug-label searches still return zero results, so this is a checked absence rather than an unmatched crosswalk. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
No US authorization
No clearance number, approval number, device class or decision date is shown, because the FDA device, PMA and drug records were searched for this brand and for its manufacturer and none of them carries it. The queries that were run are listed under Sources on this page, so the absence can be re-checked rather than taken on trust. This describes the US public record on the run date. It is not a safety finding, and the product may be authorised in other countries.
US indication: none shown, because no US record carries this brand, so FDA has assessed no indication for it. US indicationThe FDA device, PMA and drug records were searched for this brand and for its manufacturer, and no record carries it. This is a checked absence, not an unchecked one: the queries that were run are listed on the product's page. It is a statement about the US record on the run date. It is not a safety finding, and it says nothing about the product's status in any other country.
Methodology →
Evidence
No modality is assigned to this product, so no literature or trial counts are shown.
Treatment areas
No treatment area could be derived: neither the modality's condition query nor the FDA product codes contained a term on the keyword list.
Sources
- openFDA query run for this producthttps://api.fda.gov/device/pma.json?search=trade_name:"ELLANSE"&sort=decision_date:asc&limit=100
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:"ELLANSE"&sort=decision_date:desc&limit=100
- openFDA query run for this producthttps://api.fda.gov/device/pma.json?search=applicant:"Sinclair"&sort=decision_date:asc&limit=20
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=applicant:"Sinclair"&sort=decision_date:desc&limit=20
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →