CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Vydence Laser Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Etherea MX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hailie Sensor

FDA 510(k)

FDA Class 2 ·Anesthesiology

Endoform Reconstructive Template - Non Absorbable

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

END EXPIRATORY FILTER, MODEL RT020

FDA 510(k)

FDA Class 2 ·Anesthesiology

SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970

FDA 510(k)

FDA Class 2 ·General Hospital

SMARTTOUCH

FDA 510(k)

FDA Class 2 ·Anesthesiology

AIRVO HUMIDIFIER MYAIRO HUMIDIFIER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BRM2 BRAIN MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

VOLPARA, VERSION 1.3

FDA 510(k)

FDA Class 2 ·Radiology

MR590 DUAL HOSE HEATER POWER PACK

FDA 510(k)

FDA Class 2 ·Anesthesiology

CPAP HUMIDIFIER, MODEL HC238JHU

FDA 510(k)

FDA Class 2 ·Anesthesiology