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

ILD 1982-07-02

NOTIE STRETCH-LACE-VARIOUS MODELS

Applicant Fred Sammons, Inc.

K-Number K821858

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ILD 1982-07-02

ORTHOLACE 4,5.6 EYELET

Applicant Fred Sammons, Inc.

K-Number K821859

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KNK 1982-07-02

URICACID

Applicant Biodynamics Corp.

K-Number K821741

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DSP 1982-07-02

MODIFICATION OF THE PERCUTAN-BALLOON

Applicant Smec, Inc.

K-Number K813355

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GFA 1982-07-02

MICRO-SURGICAL POWER INSTRUMENT SYS.

Applicant Spire Medical, Inc.

K-Number K821487

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N/A 1982-07-02

BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800

Applicant Cranbury Medical Labs, Inc.

K-Number K827376

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N/A 1982-07-02

BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A

Applicant Cranbury Medical Labs, Inc.

K-Number K827375

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DRS 1982-07-02

DISPOSABLE BLOOD PRESSURE TRANSDUCER

Applicant Bentley Laboratories, Inc.

K-Number K821416

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GES 1982-07-02

DISP. MICROSURGICAL KNIVES

Applicant Coburn Optical Ind., Inc.

K-Number K821737

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JJX 1982-07-02

POSITIVE & NEGATIVE HCG URINE CONTROLS

Applicant Armkel, LLC

K-Number K821742

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FKQ 1982-07-02

MODEL 100 BICARBONATE CONDUCTIVITY

Applicant Western Laboratories Corp.

K-Number K821834

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CEM 1982-07-02

MODEL 1020 NA/K ANALYZER

Applicant Thermo Orion

K-Number K821822

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