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FDA Class I Medical Devices

View 10000 FDA Class I Medical Devices on BEUDAMED, the Better Database on Medical Devices. These devices are considered low-risk under FDA rules and are primarily regulated through general controls, including establishment registration, device listing, labeling, and adverse event reporting. Many Class I devices are exempt from premarket notification (510(k)), allowing manufacturers to bring products to market with simplified regulatory requirements when exemptions apply.

Use BEUDAMED listings to compare device descriptions, intended use, and regulatory status to support compliance and procurement decisions. Manufacturers and purchasers should verify specific exemptions and applicable requirements for individual products, as some Class I devices remain subject to additional controls. Search results include registration status and basic classification details to help users assess regulatory obligations.

MIDWEST ONE

FDA 510(k)
FDA Class 1 ·Dental

NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

PIN DOT FOOTREST PRODUCTS

FDA 510(k)
FDA Class 1 ·Physical Medicine

NON-PRESCRIPTION SUNGLASSES

FDA 510(k)
FDA Class 1 ·Ophthalmic

KALAZAR DETECT

FDA 510(k)
FDA Class 1 ·Microbiology

PRISMA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

KEITHLEY CLAMP

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ACE FISCHER EXTERNAL FIXATION DEVICE

FDA 510(k)
FDA Class 1 ·Orthopedic

BTE PICO SCD, PICO SC

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

O. B. PACK III

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology