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

KWY 1983-02-07

101 UNIVERSAL ENDOPROSTHESIS

Applicant Intermedics Orthopedics

K-Number K823482

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GZJ 1983-02-07

AUTO-TENS MODEL I DISPOS. SINGLE CHAN

Applicant Cbc Corp.

K-Number K823467

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DHB 1983-02-07

RIASSIST RAST DATA REDUCTION/QUALITY

Applicant Ventrex Laboratories, Inc.

K-Number K830170

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HNY 1983-02-07

DISPOSABLE CYSTOTOME

Applicant Contemporary Surgical Systems, Inc.

K-Number K830040

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BXB 1983-02-07

CONTINUOUS ANATOMICAL PASSIVE EXERCISER

Applicant Zimmer, Inc.

K-Number K830122

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FMI 1983-02-07

MYELOGRAPHY NEEDLE

Applicant Ocean Medical Products, Ltd.

K-Number K823693

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KQE 1983-02-07

GLUCOSE-6-PHOSPHATE DEHYDROGENASE

Applicant Alladin Diagnostic, Inc.

K-Number K823900

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JTO 1983-02-07

SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K823718

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KZQ 1983-02-07

SIGMA 300 GAS CHROMATROGRAPH

Applicant The Perkin-Elmer Corp.

K-Number K830147

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EMA 1983-02-07

MICRO JOIN, CROWN & BRIDGE ADHESIVE

Applicant Sci-Pharm, Inc.

K-Number K823935

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JXL 1983-02-07

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

Applicant Hudson Oxygen Therapy Sales Co.

K-Number K830090

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EWO 1983-02-07

AUDIT

Applicant Axonics, Inc.

K-Number K822335

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