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

GZJ 1983-07-18

OMNIPROBE ELECTRICAL NERVE STIMULATOR

Applicant Omni Intl., Inc.

K-Number K831147

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JPZ 1983-07-18

WAKO R-GTP C-TEST

Applicant Wako Chemicals USA, Inc.

K-Number K831639

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CIG 1983-07-18

DIRECT BILIRUBIN REAGENT

Applicant Gilford Diagnostics

K-Number K831844

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GEN 1983-07-14

GENERAL SURGICAL INSTRUMENTS

Applicant Aim Corp.

K-Number K831805

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FMC 1983-07-12

ORTHOPEDIC SURGICAL GLOVE

Applicant Ansell, Inc.

K-Number K831564

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HST 1983-07-12

COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG

Applicant Portable Travtion Device Co.

K-Number K831888

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FLL 1983-07-12

ELECTRONIC CLINICAL THERMOMETER

Applicant Mitteloy

K-Number K831718

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DXY 1983-07-12

COMMAND ULTRA II

Applicant Cardiac Pacemakers, Inc.

K-Number K831216

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BZK 1983-07-12

PORTABLE MONITORING & SCREENING SPIROM.

Applicant Boehringer Laboratories

K-Number K822689

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FLN 1983-07-12

DROP RATE COUNTER #340

Applicant Imed Corp.

K-Number K831596

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EIB 1983-07-12

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1

Applicant Western Advanced Technology, Inc.

K-Number K822411

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N/A 1983-07-12

SCENTED MENSTRUAL PAD

Applicant Personal Products Co.

K-Number K832215

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