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)

DOSIMETRY RELEASE OF RADIATION STERIL.

K-Number: K823059 · 1983-03-17

ApplicantBiomet, Inc.
Decision Date1983-03-17
Product Code
DecisionSubstantially Equivalent

Device Summary

DOSIMETRY RELEASE OF RADIATION STERIL. is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K823059. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSIMETRY RELEASE OF RADIATION STERIL.?

DOSIMETRY RELEASE OF RADIATION STERIL. is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Biomet, Inc.. The 510(k) number is K823059.

When did DOSIMETRY RELEASE OF RADIATION STERIL. receive FDA 510(k) clearance?

DOSIMETRY RELEASE OF RADIATION STERIL. received FDA 510(k) clearance on 1983-03-17, under 510(k) number K823059.

Who is the listed applicant for DOSIMETRY RELEASE OF RADIATION STERIL.?

The FDA 510(k) record lists Biomet, 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 Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

View all 418 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.

↑