CRYOPEN CRYOSURGICAL SYSTEM, K102214

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SHELHIGH PERICARDIAL PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILEX SACROILIAC JOINT FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

WUNDER PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CAPCARD

FDA 510(k)

FDA Class 2 ·General Hospital

CERTEX OCT SPINAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ICT

FDA 510(k)

FDA Class 2 ·Radiology

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

ULTRA 1040

FDA 510(k)

FDA Class 2 ·Radiology

INTERMITTENT PNEUMATIC COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CNS-EP SYSTEM AND EP 1.0 SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

O-R-EZ TIP CLEANER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS

FDA 510(k)

FDA Class 2 ·Dental

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

FDA 510(k)

FDA Class 2 ·Neurology

OCTOPAQUE UNIVERSAL

FDA 510(k)

FDA Class 2 ·Radiology

MM-RUBY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery