SMOOTH STAPLE IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

CMV EARLY ANTIGEN TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

SERIES I AND II IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EFAI PACS Picture Archiving and Communication System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI RTSuite CT HN-Segmentation System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

FDA 510(k)

FDA Class 2 ·Radiology

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

SR-IVOCAP

FDA 510(k)

FDA Class 2 ·Dental

APOLLO CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR

FDA 510(k)

FDA Class 2 ·Dental

VIVAALLOY HR (AMALGAM)

FDA 510(k)

FDA Class 2 ·Dental

FIBREFLEX

FDA 510(k)

FDA Class 2 ·Dental