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FDA 510(k)

FDA Class 2 ·Cardiovascular

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

FDA 510(k)

FDA Class 3 ·Cardiovascular

BriefCase-Triage

FDA 510(k)

FDA Class 2 ·Radiology

Cortex Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Shield System

FDA 510(k)

FDA Class 2 ·Radiology

sensiLift

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TroClose1200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Epilaser Pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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