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)

GOODLEY POLYAXIAL CERVICAL TRACTION UNIT

K-Number: K854248 · 1985-11-15

ApplicantE-Z-Em, Inc.
Decision Date1985-11-15
Product Code
DecisionSubstantially Equivalent

Device Summary

GOODLEY POLYAXIAL CERVICAL TRACTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1985-11-15 under 510(k) number K854248. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOODLEY POLYAXIAL CERVICAL TRACTION UNIT?

GOODLEY POLYAXIAL CERVICAL TRACTION UNIT is a medical device that received FDA 510(k) clearance on 1985-11-15. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K854248.

When did GOODLEY POLYAXIAL CERVICAL TRACTION UNIT receive FDA 510(k) clearance?

GOODLEY POLYAXIAL CERVICAL TRACTION UNIT received FDA 510(k) clearance on 1985-11-15, under 510(k) number K854248.

Who is the listed applicant for GOODLEY POLYAXIAL CERVICAL TRACTION UNIT?

The FDA 510(k) record lists E-Z-Em, 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 E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

View all 56 devices →

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.

↑