Sofjec

FDA 510(k)

FDA Class 2 ·General Hospital

ARIX Ankle Distal Tibia System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pastelle Pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG

FDA 510(k)

FDA Class 2 ·Radiology

RM STAR EX with RMS Needle

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CPR BAND

FDA 510(k)

FDA Class 2 ·Cardiovascular

MX50N(MX50YQS)

FDA 510(k)

FDA Class 2 ·Radiology

PicoLO Nd:YAG Picosecond Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPINAUT-P

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRAUS Dental Handpieces

FDA 510(k)

FDA Class 1 ·Dental

Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

VIVIX-S 1717N

FDA 510(k)

FDA Class 2 ·Radiology

CX50N(CX50YQS)

FDA 510(k)

FDA Class 2 ·Radiology

EdgeOne CO2 Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i

FDA 510(k)

FDA Class 2 ·Dental

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

rainbow Shine

FDA 510(k)

FDA Class 2 ·Dental

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Jeesung Safety Syringe and Single Use Needles

FDA 510(k)

FDA Class 2 ·General Hospital

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment

FDA 510(k)

FDA Class 2 ·Dental