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) Clearances

510(k) cleared devices tracked by MedTracker

N/A 1981-07-01

P.D. CRADLE

Applicant Lung Care, Inc.

K-Number K811657

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EOQ 1981-07-01

ACMI ASPIRATOR KIT #8808

Applicant American Cystocope Makers, Inc.

K-Number K811218

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ESD 1981-07-01

TELESONIC & ARCON

Applicant Telesonic, Inc.

K-Number K811031

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N/A 1981-07-01

SUPERFLOW CANNULA FOR ARTHROS. SURGERY

Applicant The Anspach Effort, Inc.

K-Number K811115

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JFS 1981-07-01

CHLORIDE/CARBON DIOXIDE RATE REAGENT

Applicant Chem-Elec, Inc.

K-Number K811701

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EBF 1981-07-01

DURAFILL MICROFILL RESTORATIVE MATERIAL

Applicant Kulzer, Inc.

K-Number K811669

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JJY 1981-07-01

HELENA FETAL-TEK 200 MARKER

Applicant Helena Laboratories

K-Number K811695

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HJM 1981-07-01

RMI TRANSILLUMINATION LIGHT METER #295

Applicant Radiation Measurements, Inc.

K-Number K811108

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GZB 1981-07-01

MYELOSTAT DORSAL CORD STIMULATOR

Applicant Medtronic Vascular

K-Number K811655

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BYG 1981-07-01

PEDIATRIC OXYGEN MASKS

Applicant Airlife, Inc.

K-Number K811711

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DQC 1981-07-01

MEDDARS/ULTRA IMAGER PULSE/PHON MODULE

Applicant Honeywell, Inc.

K-Number K811626

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DYG 1981-06-30

OCCLUSION CATHETER

Applicant Bionomy, Inc.

K-Number K811276

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