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

INM 1978-06-30

CHAIRS WITH CASTORS

Applicant Orthopedic Equipment Co., Inc.

K-Number K781001

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IQK 1978-06-30

CERVICAL COLLAR

Applicant Fox Instruments, Inc.

K-Number K780994

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JHJ 1978-06-29

ACU-TEST IN-HOME PREGNANCY TEST

Applicant Williams, the J.B. Co., Inc.

K-Number K781049

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JJQ 1978-06-28

CLINICAL ANALYZER SYSTEM

Applicant Bausch & Lomb, Inc.

K-Number K780903

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GDY 1978-06-28

SOF-WICKLAP PAD

Applicant Johnson & Johnson Professionals, Inc.

K-Number K780718

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GKL 1978-06-28

SYSMEX PLATELET COUNTER, PL-110

Applicant Toa Medical Electronics USA, Inc.

K-Number K780911

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GIF 1978-06-28

ISOTONIC DILUENT

Applicant Mallinckrodt Critical Care

K-Number K781008

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GKL 1978-06-28

SYSMEX AUTO. BLOOD CELL COUNTER, CC-120

Applicant Toa Medical Electronics USA, Inc.

K-Number K780909

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GWQ 1978-06-28

ELECTROENCEPHALOGRAPH ACCUTRACE 100

Applicant Beckman Instruments, Inc.

K-Number K781041

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JJQ 1978-06-28

FISHER SPECTROPHOTOMETER

Applicant Bausch & Lomb, Inc.

K-Number K780902

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N/A 1978-06-28

IDI GDR DATA REDUCTION SYSTEM

Applicant Iso-Data, Inc.

K-Number K780813

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ERA 1978-06-28

OTOSCOPE, DIAG. MODELS 20100 & 20200

Applicant Welch Allyn, Inc.

K-Number K781029

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