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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU WHITE SENSOR CFM, CFL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ambu aScope 4 RhinoLaryngo Slim

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU MARK IV BABY RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu aScope 4 RhinoLaryngo Intervention

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

MBD PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AMBU BLUE SENSOR NEO AND NEO X

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLOOD MONITORING UNIT, MODEL BMU 40

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery