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

N/A 1983-04-12

ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4

Applicant Sterisson

K-Number K827708

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JSF 1983-04-12

PEM-C

Applicant Health Development Corp.

K-Number K830397

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JJE 1983-04-12

OLYMPUS HIGH SPEED ANALYZER

Applicant Olympus Corp.

K-Number K830762

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GEI 1983-04-12

ELECTROSURGICAL GROUND PAD-DISPERSIVE

Applicant Con Med Equipment, Inc.

K-Number K830613

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KHQ 1983-04-12

TDX T-UPTAKE

Applicant Abbott Laboratories

K-Number K830912

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GWF 1983-04-12

CADWELL 8400

Applicant Cadwell Laboratories, Inc.

K-Number K830771

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FAE 1983-04-12

SURGITEK SIZER FOR PENILE PROSTHESIS

Applicant Medical Engineering Corp.

K-Number K830917

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FIR 1983-04-12

ASAHI BLOOD/PLASMA PUMP #ABP-01A &

Applicant Parker Hannifin Corp.

K-Number K830818

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LZN 1983-04-12

POLYETHYLENE MEDULLARY PLUG - STIIHMER/

Applicant Allo Pro Corp.

K-Number K830949

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JJW 1983-04-12

NEGATIVE URINE CONTROL

Applicant Helena Laboratories

K-Number K830834

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JCY 1983-04-12

CHEMOTHERAPY INFUSION CATHETER

Applicant American Heyer Schulte

K-Number K822096

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LHI 1983-04-12

DOUBLE LUMEN TRANSFER DEVICE

Applicant Codan Trading Co.

K-Number K830970

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