Pure Impact

FDA 510(k)

FDA Class 2 ·Physical Medicine

UGFT3; FHT7

FDA 510(k)

FDA Class 2 ·General Hospital

BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line

FDA 510(k)

FDA Class 2 ·Anesthesiology

Nanox.ARC

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GenNarino

FDA 510(k)

FDA Class 2 ·Dental

Elfor-L

FDA 510(k)

FDA Class 2 ·Cardiovascular

EARLYSENSE (EVERON) SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MORPHEUS OX

FDA 510(k)

FDA Class 2 ·Anesthesiology

XACT.CARDIAC & XPRESS.CARDIAC

FDA 510(k)

FDA Class 2 ·Radiology

HEART 400 ECG TRANSMITTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260

FDA 510(k)

FDA Class 2 ·Radiology

OTS 25-L (100-5)

FDA 510(k)

FDA Class 2 ·Orthopedic

Betta Link Knotless Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

FDA 510(k)

FDA Class 2 ·Orthopedic

ArtiFascia

FDA 510(k)

FDA Class 2 ·Neurology

Amputee Garment for use with Lympha Press Optimal Plus

FDA 510(k)

FDA Class 2 ·Cardiovascular

MP VIAL ADAPTER 13MM

FDA 510(k)

FDA Class 2 ·General Hospital