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

JMF 1980-11-12

GESTE FOLLOW KIT DETERM. OF HPL

Applicant Syn-Kit, Inc.

K-Number K802454

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DQX 1980-11-12

BENZALKONIUM-HEPARIN COATED GUIDEWIRES

Applicant Medrad, Inc.

K-Number K802473

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BSZ 1980-11-12

MODEL 5460 + 5480 POP-OFF VALVES

Applicant G. Dundas Co.

K-Number K802591

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JTZ 1980-11-12

MUELLER HINTON AGAR

Applicant Oxoid U.S.A., Inc.

K-Number K802498

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HQY 1980-11-12

TUTTIFRUTTI (NON-PRES. SUNGLASSES)

Applicant Safety Plastics of New York

K-Number K801922

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ELM 1980-11-12

REIGNING ARTIFICIAL TEETH

Applicant Oki Shiks USA , Ltd.

K-Number K802492

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KDD 1980-11-12

EMERGENCY DEPARTMENT LACERATION KIT-

Applicant Johnson & Johnson Professionals, Inc.

K-Number K802557

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CDP 1980-11-12

T3 RADIOIMMUNOASSAY KIT

Applicant American Diagnostic Corp.

K-Number K802470

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EFQ 1980-11-12

SPONGE SURGICAL GUAZE RADIOPAQUE

Applicant Barnhardt Mfg. Co.

K-Number K802504

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FMZ 1980-11-12

OHIO GC INCUBATOR

Applicant Ohio Medical Products

K-Number K802640

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CEF 1980-11-12

PARAGON SERUM PROTEIN ELECTROPHORESIS

Applicant Beckman Instruments, Inc.

K-Number K802592

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DKZ 1980-11-12

EMIT-STM AMPHETAMINE ASSAY

Applicant Syva Co.

K-Number K802623

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