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

LYA 1983-03-24

FLORET NASAL TAMPON

Applicant Ritmed, Inc.

K-Number K830263

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DXT 1983-03-24

INFLATION DEVICE

Applicant Interventional Medical, Inc.

K-Number K830609

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FRN 1983-03-24

AMBULATORY MARK I

Applicant Windsor Medical, Inc.

K-Number K822842

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EJI 1983-03-24

HENKE JECT PRESSURE SYRINGE

Applicant Smith & Nephew, Mpl Division

K-Number K830524

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CAI 1983-03-24

ANESTHESIA BREATHING CIRCUITS

Applicant Mon-A-Therm, Inc.

K-Number K830470

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DHR 1983-03-24

RA SCREENING TEST

Applicant Tago, Inc.

K-Number K830611

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DXY 1983-03-24

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN

Applicant Telectronics, Inc.

K-Number K830390

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JSY 1983-03-24

API TB-IDENT*

Applicant Analytical Products, Inc.

K-Number K830211

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DOE 1983-03-24

ABUSCREEN RADIOUMMUNOASSAY--URINE

Applicant Hoffmann-La Roche, Inc.

K-Number K830462

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KLN 1983-03-24

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META

Applicant Hoffmann-La Roche, Inc.

K-Number K830480

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FLL 1983-03-24

DISPOSABLE TEMP. PROBE & CABLE MODELS

Applicant Yellow Springs Instrument Co., Inc.

K-Number K830561

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N/A 1983-03-24

SEPTOCAL

Applicant North Pacific Dental, Inc.

K-Number K830111

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