QP-Prostate® CAD

FDA 510(k)

FDA Class 2 ·Radiology

Enobio Wireless EEG

FDA 510(k)

FDA Class 2 ·Neurology

FLIX-EMS

FDA 510(k)

FDA Class 2 ·Physical Medicine

ECG recorder and Arrhythmia Detector

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

FDA 510(k)

FDA Class 2 ·Neurology

QNext and DG-PT

FDA 510(k)

FDA Class 2 ·Hematology

Zionic Pro Max (Radiofrequency)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BOBES SLIT LAMP

FDA 510(k)

FDA Class 2 ·Ophthalmic

DOSI FLOW

FDA 510(k)

FDA Class 2 ·General Hospital

I-STOP TRANS OBTURATOR MALE SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I-STOP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Injector, Jet, Mechanical-Powered

FDA classification

FDA Class 2 ·Injector, Jet, Mechanical-Powered

Injector, Jet, Gas-Powered

FDA classification

FDA Class 2 ·Injector, Jet, Gas-Powered

Lambda, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Lambda, Fitc, Antigen, Antiserum, Control

System, Water Jet Catheter, Renal

FDA classification

FDA Class 2 ·System, Water Jet Catheter, Renal

MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR

FDA 510(k)

FDA Class 2 ·Radiology

BioRoot Flow 0.5g, BioRoot Flow 2g

FDA 510(k)

FDA Class 2 ·Dental

Biodentine XP 500, Biodentine XP 200

FDA 510(k)

FDA Class 2 ·Dental

MEDICAL DISPLAY, MDC1900-1LG (1LR)

FDA 510(k)

FDA Class 2 ·Radiology

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma