PENTADEFLUE IV SOLUTION ADMINISTRATION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Legend Pro DMA

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

OSSIOfiber Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

EndoGI S-Path Biliary Stent System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LYMPHA PRESS PLUS DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

DreaMed Advisor Pro

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CustomizedBone Service

FDA 510(k)

FDA Class 2 ·Neurology

MYAH

FDA 510(k)

FDA Class 2 ·Ophthalmic

SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

FLASH N' GO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLUORO CATHETER

FDA 510(k)

FDA Class 2 ·Radiology