Elekta Unity

FDA 510(k)

FDA Class 2 ·Radiology

Vascutek Gelsoft Plus ERS Vascular Graft

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEMPORARY LIMB SALVAGE SHUNT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MLCI2

FDA 510(k)

FDA Class 2 ·Radiology

iViewDose R1.0

FDA 510(k)

FDA Class 2 ·Radiology

DESKTOP PRO

FDA 510(k)

FDA Class 2 ·Radiology

BAUMER CEMENTED HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER LOCKING NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER MULLER HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

3nethra neo

FDA 510(k)

FDA Class 2 ·Ophthalmic

CRAIGWELL AID FITTING SYSTEM AFS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Amplifier And Signal Conditioner, Biopotential

FDA classification

FDA Class 2 ·Amplifier And Signal Conditioner, Biopotential

Chamber, Reverse Isolation, Patient Care

FDA classification

FDA Class 2 ·Chamber, Reverse Isolation, Patient Care

Non-Invasive Central Venous Manometer

FDA classification

FDA Class 2 ·Non-Invasive Central Venous Manometer

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification

FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test