Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System

FDA 510(k)

FDA Class 2 ·Orthopedic

AirFit N20

FDA 510(k)

FDA Class 2 ·Anesthesiology

Trackit T4 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

InMode System with Tone Applicator

FDA 510(k)

FDA Class 2 ·Physical Medicine

JACOB WIRZ TRANSFIXATION PIN

FDA 510(k)

FDA Class 2 ·Dental

OSSIO™ Pin Product Family

FDA 510(k)

FDA Class 2 ·Orthopedic

CAPNOMASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

VivaSight-SL (TVT) system

FDA 510(k)

FDA Class 2 ·Anesthesiology

ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200

FDA 510(k)

FDA Class 2 ·Radiology

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ARIETTA Prologue Diagnostic Ultrasound system and Transducers

FDA 510(k)

FDA Class 2 ·Radiology

GUIDED MEASUREMENT CATHETER (GMC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDINOL X-SUIT NIR BILIARY METALLIC STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VPAP AUTO WITH HUMIDAIRE 3I

FDA 510(k)

FDA Class 2 ·Anesthesiology

Novidia Universal Bond

FDA 510(k)

FDA Class 2 ·Dental

SULLIVAN MIRAGE FULL FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN

FDA 510(k)

FDA Class 2 ·Orthopedic

PLAIN CATGUT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery