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

GKT 1980-10-31

CELLTRIFUGE II

Applicant Travenol Laboratories, S.A.

K-Number K801233

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GWM 1980-10-31

CHEEK TOOL SET

Applicant Codman & Shurtleff, Inc.

K-Number K802138

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DJE 1980-10-31

EMIT-STM OPIATE ASSAY

Applicant Syva Co.

K-Number K802615

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GEH 1980-10-31

GCS-79

Applicant Gilmore Liquid Air Co.

K-Number K801921

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KNX 1980-10-31

BARD MALE EXTERNAL CATHETER

Applicant C.R. Bard, Inc.

K-Number K802433

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KKX 1980-10-31

COMFORT CUSHION DRY BURN PADS, STERILE

Applicant American Convertors Div., American Pharmaseal

K-Number K802317

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DXY 1980-10-31

MICROTHIN-DI BIPOLAR PULSE GENERATOR

Applicant Cardiac Pacemakers, Inc.

K-Number K802409

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DTE 1980-10-31

COMPUPACE, 524-01 PACER SYSTEM COMPUTER

Applicant Intermedics, Inc.

K-Number K801055

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DNN 1980-10-31

EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR

Applicant Syva Co.

K-Number K802620

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GWC 1980-10-31

PHADEBACT PNEUMOCOCCUS TEST

Applicant Pharmacia, Inc.

K-Number K802337

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EXB 1980-10-31

OSTOMATE THIRD HAND

Applicant Smith'S Ostomy Products, Inc.

K-Number K802424

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CDX 1980-10-31

T4-SQUIBB RIA KIT

Applicant E. R. Squibb & Sons, Inc.

K-Number K802456

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