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

BZH 1978-10-15

METER, FLOW, PEAK

Applicant Projects IN Health

K-Number K781224

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GZJ 1978-10-13

NURITE II, SINGLE

Applicant Bio-Medical Systems Corp.

K-Number K781683

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CCE 1978-10-12

MONITOR, PO2, INTRAVASCULAR

Applicant Roche Medical Electronics, Inc.

K-Number K781271

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GZJ 1978-10-11

ELECTRICAL NERVE STIMULATOR MODEL 6035

Applicant Stimulation Technology, Inc.

K-Number K781565

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EBF 1978-10-11

PERFIT DENTAL RESTORATIVE COMPOSITE

Applicant Locite Corp.

K-Number K781580

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HMY 1978-10-11

OSCILLATING KNIFE AND ACCESSORIES

Applicant Codman & Shurtleff, Inc.

K-Number K781412

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JQX 1978-10-11

RAD-291

Applicant Organon, Inc.

K-Number K781554

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EMX 1978-10-11

NASOSTAT

Applicant Nasostat, Inc.

K-Number K781615

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JHI 1978-10-11

EARLY PREGNANCY DETECTION KIT

Applicant Radioassay Systems Laboratories, Inc.

K-Number K781487

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N/A 1978-10-11

C.P.R. COUNTING PACER

Applicant Qual-Tec, Inc.

K-Number K781636

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IAF 1978-10-10

HEMATOLOGY STAIN PACK

Applicant Bioscientific

K-Number K781587

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KRY 1978-10-10

TEKNI-CAL

Applicant Streck Laboratories, Inc.

K-Number K781601

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