°M Warmer System

FDA 510(k)

FDA Class 2 ·General Hospital

Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CLAVIS

FDA 510(k)

FDA Class 2 ·Anesthesiology

TINNITUS SOUNDSUPPORT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LiNA OperaScope Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LINA-BAG, MODELS LB-60, LB-100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABL90 FLEX, ABL90 FLEX PLUS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

3050 DIASCOPE NT PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mag Vita TMS Therapy System w/Theta Burst Stimulation

FDA 510(k)

FDA Class 2 ·Neurology

SPEECHLINK 100 TYPE 1053

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cercare Medical Neurosuite

FDA 510(k)

FDA Class 2 ·Radiology

Ortho System

FDA 510(k)

FDA Class 2 ·Dental

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AdvaTx

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BlastGen

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR-

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Solia S Leads