MONARCH™ Platform (MON-000008)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

APEX SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RFG-3CF

FDA 510(k)

FDA Class 2 ·Neurology

Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VELOX ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECTRO-CAP SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

OSTEOPORE TCP

FDA 510(k)

FDA Class 2 ·Orthopedic

3M CURING LIGHT XL1500

FDA 510(k)

FDA Class 2 ·Dental

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System

FDA 510(k)

FDA Class 2 ·Neurology

XSTAT 30 Pouch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COSGROVE DEPTH ELECTRODE KIT(CDEK)

FDA 510(k)

FDA Class 2 ·Neurology

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]

FDA 510(k)

FDA Class 2 ·Neurology

ELI 250 ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTICAL TRACKING SYSTEM (OTS)

FDA 510(k)

FDA Class 2 ·Neurology

PACE-1A CARDIAC STIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASER MECHANISMS LASER SCANNING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROINFERTILITY NEEDLE HOLDER, TITANIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE