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

DSH 1982-10-04

ALTA III ECG RECORDER

Applicant Scole Engineering Co.

K-Number K822363

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DXY 1982-10-04

ENERTRAX MODEL 7100E

Applicant Medtronic Vascular

K-Number K822297

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DWP 1982-10-04

REUSABLE FOGARTY FLEXIBLE CALIBRATOR

Applicant American Edwards Laboratories

K-Number K822687

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FKQ 1982-10-04

DISSCAP 080

Applicant Hospal Medical Corp.

K-Number K822851

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ESD 1982-10-04

PHONIC EAR-PE 845-PPC

Applicant Phonic Ear, Inc.

K-Number K822779

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EBZ 1982-10-04

CURING LIGHT

Applicant Venture Technology, Inc.

K-Number K822654

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DSI 1982-10-04

CARDIO TEHCHANALYZER

Applicant Cardio Technology , Ltd.

K-Number K821711

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DXY 1982-10-04

COMMAND NP

Applicant Cardiac Pacemakers, Inc.

K-Number K822309

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BSY 1982-10-04

ACKRAD BRONCHITRAC

Applicant Ackrad Laboratories

K-Number K822398

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N/A 1982-10-04

ULTRA IMAGER

Applicant Honeywell, Inc.

K-Number K827408

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CCL 1982-10-04

MK 808 SERIES NASAL OXYGEN SAMPLER

Applicant Instrumentation Industries, Inc.

K-Number K822608

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DRJ 1982-10-04

PRESSURE ISOLATION AMPLIFIER #9813 517

Applicant Honeywell, Inc.

K-Number K822590

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