AESCULAP AXIAL CLIP APPLIER

FDA 510(k)

FDA Class 2 ·Neurology

HU II / HS II FIXTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EasyWhip

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FLOW-I ANESTHESIA SYSTEM C20, C30 & C40

FDA 510(k)

FDA Class 2 ·Anesthesiology

SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

AESCULAP ABC CERVICAL PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AESCULAP SPINE SYSTEM EVOLUTION

FDA 510(k)

FDA Class 2 ·Orthopedic

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VitalSigns 1-Lead Holter (VSH101)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALIEN RX MICRO CANNULA, MODEL 4530

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery