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

CAI 1979-12-19

AMBU PAEDI ANAESTHESIA SYSTEM

Applicant Narco Air-Shields

K-Number K792499

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DTM 1979-12-19

ARTERIAL BLOOD FILTER, MODEL AF-10

Applicant Bentley Laboratories, Inc.

K-Number K792450

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GBI 1979-12-19

IPOS BREAST PROSTHESIS

Applicant Ipos KG

K-Number K792372

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KRG 1979-12-19

PACEMAKER PROGRAMMER

Applicant Cardiac Pacemakers, Inc.

K-Number K792580

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ESD 1979-12-18

BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH

Applicant Danavox, Inc.

K-Number K792334

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GEI 1979-12-18

DIATHERMIC SNARE (CRESENT TYPE)

Applicant Mill-Rose Laboratory

K-Number K792343

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LAS 1979-12-18

GENTAMICIN CONTROL SERUM

Applicant Hemometrix

K-Number K792261

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EQN 1979-12-18

SHILEY LOW PRESSURE THIN-CUFFED TRACH.

Applicant Shiley, Inc.

K-Number K792222

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LAS 1979-12-18

TOBRAMYCIN CONTROL SERUM

Applicant Hemometrix

K-Number K792263

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CET 1979-12-18

LIPASE TEST KIT

Applicant Mallinckrodt Critical Care

K-Number K792289

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KKX 1979-12-18

STERILE IMPERVIOUS ORTHOPEDIC STOCKIN

Applicant Alba-Waldensian, Inc.

K-Number K792357

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HYD 1979-12-18

FAT RED 7B STAIN SET

Applicant Electrophoresis Corp. of America

K-Number K792549

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