OPTIMA

FDA 510(k)

FDA Class 2 ·Physical Medicine

K-STIK DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Envision ultrasound pad and cover

FDA 510(k)

FDA Class 2 ·Radiology

TRANS/R NEEDLE GUIDE

FDA 510(k)

FDA Class 2 ·Radiology

ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER

FDA 510(k)

FDA Class 2 ·Radiology

BIOK7600W Wireless Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

MATRIX MT-MX3

FDA 510(k)

FDA Class 2 ·Radiology

FULL SPECTRUM ULE FIBER, MODEL FF101

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625

FDA 510(k)

FDA Class 2 ·General Hospital

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)

FDA 510(k)

FDA Class 2 ·Anesthesiology

CKHEMO, MODEL CKHEMO VERSION 1.0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Anti-Glutamate Receptor (Type Nmda) Ifa

FDA classification

FDA Class 2 ·Anti-Glutamate Receptor (Type Nmda) Ifa

Monitor, Air Embolism, Ultrasonic

FDA classification

FDA Class 2 ·Monitor, Air Embolism, Ultrasonic

Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA classification

FDA Class 2 ·System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Calprotectin, Fecal

FDA classification

FDA Class 2 ·Calprotectin, Fecal

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

Test, Opiates, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Opiates, Employment And Insurance Testing, Exempt