Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXACTA-FILM

K-Number: K842512 · 1984-06-27

ApplicantArdent Intl., Inc.
Decision Date1984-06-27
Product Code
DecisionUnknown

Device Summary

EXACTA-FILM is the device name listed in this FDA 510(k) record. The listed applicant is Ardent Intl., Inc.. It received FDA 510(k) clearance on 1984-06-27 under 510(k) number K842512. FDA Decision: Unknown.

Frequently Asked Questions

What is the EXACTA-FILM?

EXACTA-FILM is a medical device that received FDA 510(k) clearance on 1984-06-27. The listed applicant is Ardent Intl., Inc.. The 510(k) number is K842512.

When did EXACTA-FILM receive FDA 510(k) clearance?

EXACTA-FILM received FDA 510(k) clearance on 1984-06-27, under 510(k) number K842512.

Who is the listed applicant for EXACTA-FILM?

The FDA 510(k) record lists Ardent Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ardent Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K864300SILIVA EJECTOR/ORAL CAVITY EVACUATORK832647ARTICULATING PAPER

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑