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

LCR 1982-01-12

TOBRAMYCIN FLUORESCENT IMMUNOASSAY

Applicant American Diagnostic Corp.

K-Number K813542

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JDR 1982-01-12

TECHMEDIA BONE STAPLE

Applicant Techmedica, Inc.

K-Number K813567

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EGD 1982-01-12

STEELE'S ECON. PINK BASEPL. WAXES, I-III

Applicant Modern Materials

K-Number K812805

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FOZ 1982-01-12

CRITIKON I.V. CATHETER PLACEMENT UNIT

Applicant Critikon Company, LLC

K-Number K813345

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KAM 1982-01-12

MAXILL-AIR SINUS VENTILATION TUBE

Applicant Xomed, Inc.

K-Number K813474

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FOZ 1982-01-12

VERSCHLUBSTOPFEN COMB-CLOSING STOPPER

Applicant Burron Medical Products, Inc.

K-Number K813396

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FMI 1982-01-12

HYPOSERMIC NEEDLES

Applicant Optical Micro Systems, Inc.

K-Number K813545

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LDE 1982-01-12

CARDIOSONIC ACOUSTIC AMPLIFIER

Applicant Srs Co.

K-Number K813510

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KTT 1982-01-12

ACE/KYLE CAPTURED HIP SCREW

Applicant Ace Orthopedic Manufacturing Co.

K-Number K813554

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HPX 1982-01-12

LENS-PAC

Applicant The Plactory

K-Number K813528

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DRS 1982-01-12

CONTINUOUS FLUSH DEVICE

Applicant Namic

K-Number K813549

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FSH 1982-01-08

PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY

Applicant American Pharmaseal Div. Ahsc

K-Number K813335

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