825 results · 23ms · Sources: EU EUDAMED, US FDA

DFS-2100

FDA 510(k)
FDA Class 2 ·Radiology

IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

OsseOne Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

OsseOne Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

VECTRA LASER SYSTEM

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

CorticaLINK Spinal Fusion Platform

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT

FDA 510(k)
FDA Class 2 ·Neurology

Kangaroo Feeding Tube with IRIS Technology

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VertebraLINK Fusion Platform

FDA 510(k)
FDA Class 2 ·Orthopedic

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

SleepImage System

FDA 510(k)
FDA Class 2 ·Anesthesiology

GOLNIT Non-Absorbable PTFE Surgical Suture

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

Cortex Laser System

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

MULTI-MODALITY IMAGE FUSION

FDA 510(k)
FDA Class 2 ·Radiology

COMPASS COMPRESSION ASSIST HANDLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

Personalized Physiology Analytics Engine software

FDA 510(k)
FDA Class 2 ·Cardiovascular

UltraEzAir® (UEA1A)

FDA 510(k)
FDA Class 2 ·Anesthesiology

Alio Medical Remote Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular