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

KOC 1979-05-02

HEMODIALYSIS BLOOD CIRCUIT

Applicant Travenol Laboratories, S.A.

K-Number K790591

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FJG 1979-05-02

HD CAPILLARY FILM DIALYZER, MODEL 1001

Applicant Travenol Laboratories, S.A.

K-Number K790533

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FKD 1979-05-02

COIL DIALYSIS, MODELS DM-360 AND DM-360-

Applicant Estracorporeal, Inc.

K-Number K790382

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GAX 1979-05-01

ESSAR TOURNIQUET FOR VENIPUNCTURE

Applicant Stewart Research, Inc.

K-Number K790802

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HST 1979-05-01

OCTAGONAL ALUMINUM FRAMING SYSTEM

Applicant Orthopedic Systems, Inc.

K-Number K790729

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FJI 1979-05-01

DISPOSABLE DIALYZERS, SD-ID, SD-2D

Applicant Bentley Laboratories, Inc.

K-Number K790308

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JSH 1979-05-01

LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID

Applicant Anaerobe Systems

K-Number K790627

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CKA 1979-05-01

COULTER ACCU-ZYME II GPT REAGENT

Applicant Coulter Electronics, Inc.

K-Number K790522

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ESD 1979-05-01

BEHIND-THE-EAR HEARING INSTRUMENT, H56

Applicant Marcon Hearing Instruments, Inc.

K-Number K790700

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DRT 1979-05-01

AS7 & AS8 MONITORS

Applicant Narco Air-Shields

K-Number K790552

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EHJ 1979-05-01

HOWMEDICA BRASS CENTER DISC

Applicant E.C. Moore Co.

K-Number K790640

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ESD 1979-05-01

_MODEL WC-1 BEHIND-THE-EAR HEARING AID

Applicant Starkey Laboratories, Inc.

K-Number K790745

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