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

DQD 1978-07-17

PENTAX ST-1A

Applicant Hal-Hen Co., Inc.

K-Number K780738

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HIL 1978-07-17

ASSURE NATURAL FIT TAMPON

Applicant Personal Products Co.

K-Number K781085

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DXY 1978-07-07

GENERATOR, PULSE, CARDIAC, IMPLANTABLE

Applicant Telectronics, Inc.

K-Number K780421

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FPX 1978-07-07

SUTURELESS SKIN CLOSURE

Applicant Abbott Laboratories

K-Number K780565

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IPF 1978-07-07

GALVANATOR, MODEL 770

Applicant Avra Corp.

K-Number K781080

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JEB 1978-07-07

CAST BLOCK

Applicant Orthopedic Equipment Co., Inc.

K-Number K781082

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KDJ 1978-07-06

SET, ADMINISTRATION, MANUAL, DIALYSIS

Applicant American Medical Products, Inc.

K-Number K780957

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DYT 1978-06-30

SAFETY STOP NECKSTRAP

Applicant Northwest Orthodontics, Inc.

K-Number K780814

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KHE 1978-06-30

FECATEST

Applicant Otto C. Watzka

K-Number K780564

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EBZ 1978-06-30

INSTANT CURE-1

Applicant Ultra-Light Corp.

K-Number K780898

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DTC 1978-06-30

EXTERNAL TEST PULSE GENERATOR

Applicant Vitatron Medical BV

K-Number K780717

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JOM 1978-06-30

ELECTRO-PLETHYSMOGRAPH

Applicant Biotecx Laboratories, Inc.

K-Number K780761

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