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 1978-09-27

PACEMAKER, MODEL 225 & 227

Applicant Intermedics, Inc.

K-Number K772226

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CDX 1978-09-27

ORTHO*T-4 RIA (PEG) KIT

Applicant Ortho Diagnostics, Inc.

K-Number K781483

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CCQ 1978-09-27

PULMO-SONIC

Applicant The Devilbiss Co.

K-Number K781073

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BYF 1978-09-27

MARKII VENTIMASKS

Applicant Vickers America Medical Corp.

K-Number K781325

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JOD 1978-09-27

INTERFACE CARDIOTOMY BLOOD FILTER

Applicant Medical, Inc.

K-Number K781383

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EHZ 1978-09-27

STERI-VAC POWER UNITS

Applicant Cpac, Inc.

K-Number K781486

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ESD 1978-09-27

HEARING AID, MODEL 775 PP/AGC

Applicant Danavox, Inc.

K-Number K781596

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GEN 1978-09-27

HARRINGTON HOOK CLAMP

Applicant Orthopedic Equipment Co., Inc.

K-Number K781448

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GFC 1978-09-27

DRIVERS

Applicant Orthopedic Equipment Co., Inc.

K-Number K781450

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N/A 1978-09-27

RESURFACE PROSHESIS

Applicant Aesculap Instruments Corp.

K-Number K781343

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ESD 1978-09-27

BODY-WORN HEARING AID, MODEL 787PP

Applicant Danavox, Inc.

K-Number K781595

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IPF 1978-09-26

MUSCLE STIMULATOR, ELECTRICAL

Applicant Rich-Mar Corp.

K-Number K781113

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