BARD BIOPOTENTIAL AMPLIFIER II

FDA 510(k)

FDA Class 2 ·Cardiovascular

BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST RXi Mini System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SFA-II MICROPROCESSOR-CONTROLLED MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESSURE MODULE (MODEL P3)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGERY DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTERNAL VALVE FUNCTION BLOCK

FDA 510(k)

FDA Class 2 ·Cardiovascular

CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Anovo Surgical System (Model 6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROLINK ADHESIVES (PROLINK, PROLINK SE)

FDA 510(k)

FDA Class 2 ·Dental

NOVA Dental Implants System

FDA 510(k)

FDA Class 2 ·Dental

iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology