Tel-O-Graph

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ambu USR, Ambu M

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·COOK MBC PTCA BALLOON DILATATION CATHETER

Sleepware G3

FDA 510(k)

FDA Class 2 ·Neurology

TRABECULO-SUPRACHOROIDAL SHUNT

FDA 510(k)

FDA Class 2 ·Ophthalmic

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU TUBECHECK

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu® aScope™ Colon; Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ Gastro, Ambu® aBox™2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMBU LIFE KEY AND AMBU RES-CUE KEY

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ Gastro Large; Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU SUCTION BOOSTER

FDA 510(k)

FDA Class 2 ·General Hospital

VALVE, AMBU PEEP

FDA 510(k)

FDA Class 2 ·Anesthesiology