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

CZX 1978-02-28

HEMOPEXIN NEPHELOMETRIC ASSAYS

Applicant Kallestad Laboratories, Inc.

K-Number K780250

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FPS 1978-02-28

BED BOARD

Applicant Biomet, Inc.

K-Number K780230

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GEI 1978-02-28

ELECTRO-SURGICAL GROUNDING PAD

Applicant Johnson & Johnson Professionals, Inc.

K-Number K780298

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N/A 1978-02-28

BARRIER HIP PACK W/ FABRIC 450

Applicant Surgikos, Inc.

K-Number K780282

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GDJ 1978-02-28

ULNAR-RADIAL CLIP

Applicant Edward Weck, Inc.

K-Number K780290

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GDJ 1978-02-28

BRACHIAL-LARGE VESSEL APPROXIMATOR

Applicant Edward Weck, Inc.

K-Number K780286

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EMA 1978-02-28

CAULK TYLOK

Applicant L.D. Caulk Co.

K-Number K780301

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GNS 1978-02-28

INFLUENZA HI PRESERUM A/TEXAS

Applicant Flow Laboratories, Inc.

K-Number K780277

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GDJ 1978-02-28

BRACHEAL-LARGE VESSEL CLIP

Applicant Edward Weck, Inc.

K-Number K780288

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GNS 1978-02-28

INFLUENZA HI ANTISERUM A/TEXAS

Applicant Flow Laboratories, Inc.

K-Number K780276

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EWO 1978-02-27

COMPUTER AUDIOMETER - MA25

Applicant Maico Hearing Instruments, Inc.

K-Number K780269

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DWS 1978-02-27

IMPCO DISPOSABLE AORTIC PUNCH

Applicant Thoratec Laboratories Corp.

K-Number K780247

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