297 results · 21ms · Sources: EU EUDAMED, US FDA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000

FDA 510(k)
FDA Class 2 ·Physical Medicine

OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

FDA 510(k)
FDA Class 2 ·Radiology

GMK Sphere

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK Sphere Revision

FDA 510(k)
FDA Class 2 ·Orthopedic

MectaTap TI Suture Anchor

FDA 510(k)
FDA Class 2 ·Orthopedic

MectaLock All-Suture Anchors

FDA 510(k)
FDA Class 2 ·Orthopedic

M-ARS ACL: Anatomic Ribbon Surgery System

FDA 510(k)
FDA Class 2 ·Orthopedic

Advanced MyHip Planner

FDA 510(k)
FDA Class 2 ·Radiology

MyKnee R Pin Positioners

FDA 510(k)
FDA Class 2 ·Orthopedic

MectaLIF Anterior Stand Alone Extension

FDA 510(k)
FDA Class 2 ·Orthopedic

Mpres Neck Preserving Stem

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK Hinge, GMK Revision

FDA 510(k)
FDA Class 2 ·Orthopedic

MyKnee UNI-ST

FDA 510(k)
FDA Class 2 ·Orthopedic

M.U.S.T. Pedicle Screw Extension and Long Tab Implants

FDA 510(k)
FDA Class 2 ·Orthopedic

MySpine Cervical Guides

FDA 510(k)
FDA Class 2 ·Orthopedic

MyHip Planner & Verifier

FDA 510(k)
FDA Class 2 ·Radiology

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

FDA 510(k)
FDA Class 2 ·Orthopedic

MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)

FDA 510(k)
FDA Class 2 ·Orthopedic

M.U.S.T. MINI Posterior Cervical Screws System

FDA 510(k)
FDA Class 2 ·Orthopedic