AMBU NEONATE SILICONE RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPUR ADULT WITH OPEN RESERVOIR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu aScope RLS Slim

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU MARK IV RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu aScope 4 Cysto

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMBU UNIVERSAL SUCTION PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMBU ASCOPE AND MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Wireless EEG System

FDA 510(k)

FDA Class 2 ·Neurology

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·General Hospital

IQvitals Zone

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat