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

DXY 1980-01-11

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.

Applicant Telectronics, Inc.

K-Number K800030

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JHW 1980-01-11

CREATINE PHOSPHOKINASE (CPK) REAGENT SET

Applicant Macomb Chemical Co.

K-Number K792533

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GDY 1980-01-11

STERILIZATION PROCESS/X-RAY DETECT. SPG

Applicant Procter & Gamble Mfg. Co.

K-Number K792630

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JCX 1980-01-11

AMBU UNIVERSAL SUCTION PUMP

Applicant Narco Air-Shields

K-Number K792592

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EFQ 1980-01-11

STERILIZATION PROCESS/VAGINAL SPONGE

Applicant Procter & Gamble Mfg. Co.

K-Number K792628

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KET 1980-01-11

STERILIZATION PROCESS/OUTERWRAP

Applicant Procter & Gamble Mfg. Co.

K-Number K792633

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KTS 1980-01-11

CENTRIA RADIOIMMUNOASSAY SEPARATION

Applicant Union Carbide Corp.

K-Number K792636

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JSS 1980-01-11

ENTERIC-TEK

Applicant Flow Laboratories, Inc.

K-Number K792058

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DQK 1980-01-11

DYE CURVE EVALUATOR

Applicant Sci-Pro, Inc.

K-Number K792135

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DLP 1980-01-11

FLUOROMATIC PHENYTOIN FIA

Applicant Bio-Rad

K-Number K792640

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CIX 1980-01-11

CHEMISTRY ANALYZER REAGENTS

Applicant Laboratory Products, Inc.

K-Number K792482

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JXA 1980-01-11

CULTURIA MACCONKEY/COLUMBIA CNA

Applicant Clinical Convenience Products, Inc.

K-Number K792579

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