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)

HANSON MEDICAL FACIAL IMPLANTS

K-Number: K090803 · 2010-06-30

ApplicantHanson Medical, Inc.
Decision Date2010-06-30
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANSON MEDICAL FACIAL IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 2010-06-30 under 510(k) number K090803. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANSON MEDICAL FACIAL IMPLANTS?

HANSON MEDICAL FACIAL IMPLANTS is a medical device that received FDA 510(k) clearance on 2010-06-30. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K090803.

When did HANSON MEDICAL FACIAL IMPLANTS receive FDA 510(k) clearance?

HANSON MEDICAL FACIAL IMPLANTS received FDA 510(k) clearance on 2010-06-30, under 510(k) number K090803.

Who is the listed applicant for HANSON MEDICAL FACIAL IMPLANTS?

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

What is the FDA product code for HANSON MEDICAL FACIAL IMPLANTS?

The FDA product code for HANSON MEDICAL FACIAL IMPLANTS is FZE.

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 Hanson Medical, 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.

K071018MONARCH NASAL IMPLANTK041690MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030809HANSON MEDICAL GLUTEAL IMPLANTK030808HANSON MEDICAL CALF IMPLANTK973729POWERFLEX PEC IMPLANT

View all 13 devices →

Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, Inc.K021418AART NASAL IMPLANTAesthetic and Reconstructive Technologies, Inc.

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.

↑