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FDA Class II Medical Devices

View 10000 FDA Class II Medical Devices on BEUDAMED, the Better Database on Medical Devices. FDA Class II devices are considered moderate-risk products that typically require 510(k) clearance demonstrating substantial equivalence to a predicate device. These devices are subject to special controls, performance standards, and specific labeling and postmarket requirements to ensure ongoing safety and effectiveness.

FDA Class II devices cover a wide range of products, including diagnostic tests, infusion pumps, and many surgical instruments. Manufacturers must comply with Quality System Regulation (QSR), device listing and registration, and mandatory adverse event reporting while monitoring real‑world performance. BEUDAMED provides regulatory details, clearance dates, and manufacturer information to help locate and compare Class II device records.

DANEK PRECISION ROD SET

FDA 510(k)
FDA Class 2 ·Orthopedic

MICRO-MEDIA MICRODILUTION TEST PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

MONO ACU-SLIDE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

FDA 510(k)
FDA Class 2 ·Cardiovascular

LAPAROSCOPIC CATHERTER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OptaBlate Radiofrequency (RF) Generator System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SwissMembrane X; SwissMembrane X Socket

FDA 510(k)
FDA Class 2 ·Dental

SOMATOM X.cite; SOMATOM X.ceed

FDA 510(k)
FDA Class 2 ·Radiology

DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123

FDA 510(k)
FDA Class 2 ·Neurology