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

CFR 1977-02-23

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K770262

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IPM 1977-02-23

HEAVY FOAM HEEL & ELBOW PROTECTORS

Applicant Robert R. Moore

K-Number K770223

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CGX 1977-02-22

REAGENT SYSTEM

Applicant American Monitor Corp.

K-Number K770242

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FAM 1977-02-18

SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125

Applicant Welch Allyn, Inc.

K-Number K770291

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JSE 1977-02-18

API 3S

Applicant Analytical Products, Inc.

K-Number K770176

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FLB 1977-02-18

DIALYSATE METER RS-2100A, CIRCUIT CHANGE

Applicant Renal Systems, Inc.

K-Number K770263

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JTY 1977-02-18

MARTIN-LEWIS AGAR MEDIUM

Applicant Gibco Laboratories Life Technologies, Inc.

K-Number K770287

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GGC 1977-02-18

HPC TM (HEPARINIZED PLASMA CONTROL)

Applicant Bio/Data Corp.

K-Number K770188

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NUW 1977-02-18

MONITOR, MYO, MODEL J3

Applicant Myo-Tronics Research, Inc.

K-Number K770252

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HNI 1977-02-17

IRIS RETRACTOR

Applicant Concept, Inc.

K-Number K770222

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IPF 1977-02-17

STIMULATOR, ELECTRICAL MUSCLE (#MD-4)

Applicant R. A. Fischer Co. Corp.

K-Number K760547

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KDH 1977-02-17

IRRIGATION CATHETER

Applicant Sherwood Medical Industries

K-Number K760556

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