CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

HandPICO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

FDA 510(k)

FDA Class 2 ·Immunology

CARTO 3 EP Navigation System, Version 6.0 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 7.1 and Accessories

FDA 510(k)

FDA Class 2 ·Cardiovascular

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

FDA 510(k)

FDA Class 2 ·Dental

CARTO® 3 EP Navigation System with Signal Processing Unit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNILUX REVIVE AND BLUE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·Physical Medicine

Radify Triage

FDA 510(k)

FDA Class 2 ·Radiology

OMNILUX REVIVE AND OMNILUX PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Vydence Laser Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Etherea MX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMES TDA/GENTGMICIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology