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

DXY 1978-02-13

CARDIAC PULSE GENERATOR, MODEL 160B

Applicant Telectronics, Inc.

K-Number K780113

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JMK 1978-02-13

ULTRAZYME PLUS HBD

Applicant Harleco

K-Number K780104

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CIT 1978-02-13

ULTRAZYME PLUS GOT

Applicant Harleco

K-Number K780103

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IMX 1978-02-13

WHEELCHAIR ACCESSORIES

Applicant Orthopedic Equipment Co., Inc.

K-Number K780184

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DSF 1978-02-13

RECORDER, PAPER, ECG

Applicant Telectronics, Inc.

K-Number K772333

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DQR 1978-02-13

CANNULA, ARTERY, RENAL

Applicant Dravon Medical, Inc.

K-Number K780079

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DON 1978-02-13

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA

Applicant Bio-Rad

K-Number K772422

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JMO 1978-02-13

IRON BINDING CAPACITY CHEMISTRY

Applicant Harleco

K-Number K780094

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DID 1978-02-13

TOBRAMYCIN 125I RIA KIT

Applicant New England Nuclear

K-Number K780182

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N/A 1978-02-13

LDH-L REAGENT SET

Applicant Medical Analysis Systems, Inc.

K-Number K780074

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JMK 1978-02-13

HBDH REAGENT SET

Applicant Medical Analysis Systems, Inc.

K-Number K780073

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ION 1978-02-13

FINGER EXERCISE BOARD

Applicant Fred Sammons, Inc.

K-Number K772404

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