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

KNT 1982-01-12

FECAL SANITARY TUBE

Applicant Leon'S Fecal Sanitary Tub Mfg.

K-Number K813526

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KLE 1982-01-12

SCOTCHBOND DENTAL ADHESIVE

Applicant 3M Company

K-Number K813180

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ESD 1982-01-12

PHONIC EAR MODEL PE805CD

Applicant Phonic Ear, Inc.

K-Number K813583

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KFJ 1982-01-12

IMPLANT AID SPLICING CRIMP & SLEEVE

Applicant Intermedics, Inc.

K-Number K813518

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GBS 1982-01-12

DISPOSABLE THORACIC CATHETER

Applicant Texas Medical Products, Inc.

K-Number K813587

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BZQ 1982-01-12

INFALERT

Applicant Briox Technologies, Inc.

K-Number K813507

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KLQ 1982-01-12

AMIKACIN FLUORESCENT IMMUNOASSAY

Applicant American Diagnostic Corp.

K-Number K813541

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KNS 1982-01-12

ELECTROSURGICAL DISP. DISPERSIVE PAD

Applicant Promedicon, Inc.

K-Number K813434

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BYJ 1982-01-12

UNIT, LIQUID, OXYGEN, PORTABLE

Applicant Pensee Medical Corp.

K-Number K813453

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ESD 1982-01-12

RIONET HEARING AID HI-62

Applicant Rion Acoustic Instruments, Inc.

K-Number K813546

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FLL 1982-01-12

WA-2000 TEMPERATURE INDICATOR

Applicant Wallach Surgical Devices, Inc.

K-Number K813402

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KNX 1982-01-12

URIFIX

Applicant Isramed, Inc.

K-Number K813537

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