TEMPFX ESTHETIC PROVISIONAL SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Beamscan MR

FDA 510(k)

FDA Class 2 ·Radiology

HI TORQUE CONNECT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONNECTED CARE CLINICAL APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXMEDICS MALLEABLE CANNULA

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXA™ NPWT System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEXA Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTIFICIAL SCLERAL SHELL

FDA 510(k)

FDA Class 2 ·Ophthalmic

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

Adhesive Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Single-use Flexible Ureteroscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREXION3D ECLIPSE

FDA 510(k)

FDA Class 2 ·Radiology

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electric nasal aspirator (HTD2601US)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular