SofWave System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSSIOfiber® Cannulated Trimmable Fixation Nail

FDA 510(k)

FDA Class 2 ·Orthopedic

CarboClear® Hybrid Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

PICCOLO COMPOSITE NAILING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

YandR System, VoluDerm Handpiece, VoluDerm Tips

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I.V. SET WITH AND WITHOUT AIR VENT

FDA 510(k)

FDA Class 2 ·General Hospital

OPUSDUO EC DENTAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CG-2211 SELFCHECK ECG TRANSMITTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

AFF (MARK I) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

LITETOUCH DENTAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISCOVERY NM 750B

FDA 510(k)

FDA Class 1 ·Radiology

SATURN DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

Sensilight Pro / Pistol IPL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Spiral Shape Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments

FDA 510(k)

FDA Class 2 ·Dental

LVivo Software Application

FDA 510(k)

FDA Class 2 ·Radiology

ENVOY PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular