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

KOD 1980-12-16

ARGYLE HEMATURIA BALLOON CATHETER

Applicant Sherwood Medical Co.

K-Number K802875

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EMA 1980-12-16

POLYCARBONATE TEMPORARY CEMENT

Applicant Buffalo Dental Mfg. Co., Inc.

K-Number K802662

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EQH 1980-12-16

FIBER OPTIC ADAPTER #60-895

Applicant Aspen Laboratories, Inc.

K-Number K802771

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DRG 1980-12-16

TECNOL TELEMETRY UNIT POUCH

Applicant Tecnol New Jersey Wound Care, Inc.

K-Number K802849

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DXN 1980-12-16

BLOOD PRESSURE UNIT MODEL 410

Applicant Js & A Group

K-Number K802412

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KNX 1980-12-16

ARGYLE CLOSED URINARY DRAINAGE SET

Applicant Sherwood Medical Co.

K-Number K802667

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GBN 1980-12-16

SURGEONS CHOICE STAPLE, REMOVE/IMPLANT

Applicant Hospital Products Intl.

K-Number K802783

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EQH 1980-12-16

FIBER OPTIC ADAPTER #60-0894

Applicant Aspen Laboratories, Inc.

K-Number K802772

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DTZ 1980-12-16

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S

Applicant Bentley Laboratories, Inc.

K-Number K802719

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KPD 1980-12-16

ELECTRONIC DIGITAL THERMOMETER

Applicant Philip J. Teders

K-Number K802897

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DXN 1980-12-16

BLOOD PRESSURE UNIT MODEL 310

Applicant Js & A Group

K-Number K802411

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EQH 1980-12-16

FIBER OPTIC ADAPTER #60-0892

Applicant Aspen Laboratories, Inc.

K-Number K802774

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