NewTom 5G

FDA 510(k)

FDA Class 2 ·Radiology

Delta Dual Mobility System

FDA 510(k)

FDA Class 2 ·Orthopedic

Q-PLUS T

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Retia 2

FDA 510(k)

FDA Class 2 ·Ophthalmic

JDZygoma dental implants

FDA 510(k)

FDA Class 2 ·Dental

G3A 40 Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Colibrí

FDA 510(k)

FDA Class 2 ·Microbiology

MACLIN POWER INTRAVASCULAR ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

turbodent touch

FDA 510(k)

FDA Class 2 ·Dental

EchoS Family

FDA 510(k)

FDA Class 2 ·Radiology

Wave Electrode (AE02-60); Wave Electrode (AE02-50)

FDA 510(k)

FDA Class 2 ·Neurology

MTS Gentamicin 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

PENTADEFLUE IV SOLUTION ADMINISTRATION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

MTS Omadacycline 0.002 - 32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

SMR Reverse HP Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nuvola

FDA 510(k)

FDA Class 2 ·Dental

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line

FDA 510(k)

FDA Class 2 ·Cardiovascular