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)

SEARE BIOMEDICAL MALAR IMPLANTS

K-Number: K982763 · 1998-09-30

ApplicantSeare Biomedical Corp.
Decision Date1998-09-30
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEARE BIOMEDICAL MALAR IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Seare Biomedical Corp.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K982763. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEARE BIOMEDICAL MALAR IMPLANTS?

SEARE BIOMEDICAL MALAR IMPLANTS is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Seare Biomedical Corp.. The 510(k) number is K982763.

When did SEARE BIOMEDICAL MALAR IMPLANTS receive FDA 510(k) clearance?

SEARE BIOMEDICAL MALAR IMPLANTS received FDA 510(k) clearance on 1998-09-30, under 510(k) number K982763.

Who is the listed applicant for SEARE BIOMEDICAL MALAR IMPLANTS?

The FDA 510(k) record lists Seare Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEARE BIOMEDICAL MALAR IMPLANTS?

The FDA product code for SEARE BIOMEDICAL MALAR IMPLANTS is LZK.

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 Seare Biomedical Corp. 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.

K983792SEARE BIOMEDICAL SILICONE TISSUE EXPANDERK983630SEARE BIOMEDICAL SILICONE RODSK982752SEARE BIOMEDICAL CHIN IMPLANTSK982753SEARE BIOMEDICAL NASAL IMPLANTSK983043SEARE BIOMEDICAL SILICONE BLOCKK982762SEARE BIOMEDICAL PECTORALIS IMPLANT

View all 8 devices →

Related Devices (Code: LZK)

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K981835SILIMED MALAR IMPLANTSilimed, LLCK980141SPECTRUM DESIGNS PROJECTION MALAR IMPLANTSpectrum Designs, 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.

↑