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

HHM 1981-01-12

UTERINE SOUND

Applicant Gynemetrics, Inc.

K-Number K802315

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JTW 1981-01-12

MINI-TIP CULTURETTE

Applicant Marion Laboratories, Inc.

K-Number K803298

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GNX 1981-01-12

INFLUENZA A & B S-ANTIGEN & CONTROLS

Applicant Orion Diagnostica, Inc.

K-Number K802931

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GWS 1981-01-12

MEUROMETRICS MONITOR

Applicant Dade Medical, Inc.

K-Number K803233

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HSZ 1981-01-09

OSTEO OSCILAIR

Applicant Richard'S Medical Equip., Inc.

K-Number K803284

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JHX 1981-01-09

PARAGON ELECTRO. CREATINE KINASE TEST KI

Applicant Beckman Instruments, Inc.

K-Number K802826

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IZO 1981-01-09

CINESCOPE III RADIOGRAPHIC GENERATOR

Applicant Controtec, Inc.

K-Number K802941

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HRS 1981-01-09

INTEROOM(POWERED OPHTHALMIC TABLE)

Applicant Jocevest Interoom, Inc.

K-Number K803176

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HCC 1981-01-09

EMG-UT 30

Applicant American Scientific Corp.

K-Number K802390

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JAA 1981-01-09

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM

Applicant General Electric Co.

K-Number K802953

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CIX 1981-01-09

AMES SERA-PAK ALBUMIN REAGENT KIT

Applicant Miles Laboratories, Inc.

K-Number K803237

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LGF 1981-01-09

CONPHAR CAST HEELS

Applicant Conphar, Inc.

K-Number K803141

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