PLEXR PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MT One Diamond

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

FDA 510(k)

FDA Class 2 ·Dental

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMR Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WINSIX Implant System

FDA 510(k)

FDA Class 2 ·Dental

KITE Distal Fibula Kit

FDA 510(k)

FDA Class 2 ·Orthopedic

MrOpen

FDA 510(k)

FDA Class 2 ·Radiology

Lexa MINI (RIS-303, RIS-305)

FDA 510(k)

FDA Class 2 ·General Hospital

RAPIDO HOLLOW-FIBRE DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OrthoPulse 2.0E (OPi2E-100)

FDA 510(k)

FDA Class 2 ·Dental

ECG HOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

MP-1 MICROPERIMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

CRP DIAGNOSTIC ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Discovery Pico, Discovery Pico Plus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Scrambler Therapy MC-5 A Device

FDA 510(k)

FDA Class 2 ·Neurology

Pentaflush

FDA 510(k)

FDA Class 2 ·General Hospital