FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION

Device

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·On the market·6 countries

MOBILE GAMMA CAMERAS

Device

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·On the market·7 countries

FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION

Device

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·On the market·1 country

FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION

Device

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·On the market·2 countries

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD

MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E4D COMPASS

FDA 510(k)

FDA Class 2 ·Radiology

FOTONA DUALIS ER:YAG/KTP LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA SKINPLUS LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

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

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery