MATRIX RF APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UniFit Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

RANDOX HAEMOGLOBIN A1C

FDA 510(k)

FDA Class 2 ·Hematology

Vial2Bag Advanced® 13mm Admixture Device

FDA 510(k)

FDA Class 2 ·General Hospital

Compass BDS Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

FDA 510(k)

FDA Class 2 ·Hematology

Bonus Therapeutics Mixing and Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

INMODE WMBODY DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EpiFinder

FDA 510(k)

FDA Class 2 ·General Hospital

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLYMPUS IGA REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

GUARDIAN HEMOSTASIS VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSSIOfiber® Staple

FDA 510(k)

FDA Class 2 ·Orthopedic

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIR BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLEEK OTW PTA CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LACTATE DEHYDROGENASE (LD)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry