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

ILI 1980-07-28

ARM SLING

Applicant The Owenby Co.

K-Number K801626

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KRB 1980-07-28

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

Applicant Edwards Laboratories

K-Number K801552

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IDL 1980-07-28

TISSUE-TEK III MICROJECT DISP. BLADE SYS

Applicant Miles Laboratories, Inc.

K-Number K801426

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FQM 1980-07-28

WINTER HEAD DRESSING

Applicant Steridyne Corp.

K-Number K801458

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IEO 1980-07-28

TISSUE-TEK III MINI-RAPID PROCESSOR

Applicant Miles Laboratories, Inc.

K-Number K801427

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FQM 1980-07-28

STOCKINETTE, STERILE TWO PLY W/PULL TABS

Applicant The Owenby Co.

K-Number K801532

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FJI 1980-07-28

COBE HF80, CAT. #18-580

Applicant Cobe Laboratories, Inc.

K-Number K801178

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KIH 1980-07-28

OH-HARRIS

Applicant Johnson & Johnson Professionals, Inc.

K-Number K801388

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HLN 1980-07-28

LEIGH MEASURING SCALE #7725

Applicant Edward Weck, Inc.

K-Number K801466

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FRG 1980-07-28

VAL-U-WRAP CSR WRAP

Applicant American Convertors Div., American Pharmaseal

K-Number K801569

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GGW 1980-07-28

PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT

Applicant Pacific Hemostasis

K-Number K801460

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HQF 1980-07-28

MODEL 900K PHOTOCOAGULATOR

Applicant Coherent Medical Division

K-Number K801336

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