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)

MICOMED - HALM ZIELKE INSTRUMENTATION

K-Number: K982006 · 1999-01-20

ApplicantMicomed GmbH
Decision Date1999-01-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICOMED - HALM ZIELKE INSTRUMENTATION is the device name listed in this FDA 510(k) record. The listed applicant is Micomed GmbH. It received FDA 510(k) clearance on 1999-01-20 under 510(k) number K982006. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICOMED - HALM ZIELKE INSTRUMENTATION?

MICOMED - HALM ZIELKE INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Micomed GmbH. The 510(k) number is K982006.

When did MICOMED - HALM ZIELKE INSTRUMENTATION receive FDA 510(k) clearance?

MICOMED - HALM ZIELKE INSTRUMENTATION received FDA 510(k) clearance on 1999-01-20, under 510(k) number K982006.

Who is the listed applicant for MICOMED - HALM ZIELKE INSTRUMENTATION?

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

What is the FDA product code for MICOMED - HALM ZIELKE INSTRUMENTATION?

The FDA product code for MICOMED - HALM ZIELKE INSTRUMENTATION is KWQ.

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 Micomed GmbH 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.

K991862MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.

↑