DELFIA HTSH ULTRA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Planmeca Romexis

FDA 510(k)

FDA Class 2 ·Radiology

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPNOMAC ULTIMA ANESTHESIA MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Planmed Verity

FDA 510(k)

FDA Class 2 ·Radiology

SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

FOTONA DUALIS, FOTONA DUALIS PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgify Halo

FDA 510(k)

FDA Class 2 ·Neurology

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

FDA 510(k)

FDA Class 2 ·Orthopedic

FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DELFIA DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Planmeca ProMax 3D Max, Planmeca Maximity

FDA 510(k)

FDA Class 2 ·Radiology

PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

cNeuro cDAT

FDA 510(k)

FDA Class 2 ·Radiology