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)

HMD-2000 BATTERY-POWERED MINI-DRILL, THE

K-Number: K780645 · 1978-05-03

ApplicantMedishield, Inc.
Decision Date1978-05-03
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HMD-2000 BATTERY-POWERED MINI-DRILL, THE is the device name listed in this FDA 510(k) record. The listed applicant is Medishield, Inc.. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780645. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HMD-2000 BATTERY-POWERED MINI-DRILL, THE?

HMD-2000 BATTERY-POWERED MINI-DRILL, THE is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Medishield, Inc.. The 510(k) number is K780645.

When did HMD-2000 BATTERY-POWERED MINI-DRILL, THE receive FDA 510(k) clearance?

HMD-2000 BATTERY-POWERED MINI-DRILL, THE received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780645.

Who is the listed applicant for HMD-2000 BATTERY-POWERED MINI-DRILL, THE?

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

What is the FDA product code for HMD-2000 BATTERY-POWERED MINI-DRILL, THE?

The FDA product code for HMD-2000 BATTERY-POWERED MINI-DRILL, THE is KIJ.

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 Medishield, 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.

K781103SPECTRASCANK780646AIR-PWOERED COLDRILLK780202MONOMER EVACUATION SYSTEMK770161MICROFENESTRATED HIP REPLACEMENT COMPON.K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)K761020ANKLE (FREEMAN-SWANSON)

View all 8 devices →

Related Devices (Code: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, 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.

↑