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

ETA 1983-06-24

AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

Applicant Treace Medical, Inc.

K-Number K823912

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KTC 1983-06-24

SITZ BATH, SINGLE PATIENT USE #8100

Applicant Lsl Industries, Inc.

K-Number K831762

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N/A 1983-06-24

BF24 DOPPLER MODEL P872 AND P874

Applicant Medasonics, Inc.

K-Number K837481

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KQW 1983-06-24

FINGER BONIOMETER BK7506

Applicant Fred Sammons, Inc.

K-Number K831550

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CAE 1983-06-24

STRAITH ORAL AIRWAY

Applicant Surgical Technology Laboratories, Inc.

K-Number K831078

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JDI 1983-06-24

MILWAUKEE AUSTIN MOORE TOTAL HIP

Applicant Biomet, Inc.

K-Number K830314

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KNP 1983-06-24

IPOS ANTI-ADDUCTUS SHOE

Applicant Ipos Luneburg

K-Number K831690

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KKX 1983-06-24

ISOVIS WOUND PROTECTOR

Applicant Ritmed, Inc.

K-Number K830270

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KQZ 1983-06-24

TPG 1000

Applicant Physical Diagnostics, Inc.

K-Number K831002

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IOD 1983-06-24

DELUXE TRACTION EXERCISE GLOVE BK5035

Applicant Fred Sammons, Inc.

K-Number K831544

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ILI 1983-06-24

SATO FAMILY FIRST AID KIT

Applicant Food and Drug Service, Inc.

K-Number K831706

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ETA 1983-06-24

AUSTIN MODIFIED PARTIAL OSSICULAR RE-

Applicant Treace Medical, Inc.

K-Number K823918

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