APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)

FDA 510(k)

FDA Class 2 ·Dental

CHIPS STANDUP WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENFit enteral syringes (NUTRIFIT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE

FDA 510(k)

FDA Class 2 ·Orthopedic

BioCode Respiratory Pathogen Panel (RPP)

FDA 510(k)

FDA Class 2 ·Microbiology

Occlusion Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioCode Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

ELUMI 810 + 980 Soft Tissue Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

J.B. S. C1-C2 CLAMP

FDA 510(k)

FDA Class 2 ·Orthopedic

Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

STENT GRAFT BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CINA

FDA 510(k)

FDA Class 2 ·Radiology

2D TOF ANGIOGRAHY MEASURING FUNCTION

FDA 510(k)

FDA Class 2 ·Radiology

2D, 3D TOF MR ANGIOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

2D,3D, TOF MR ANGIOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER