COMCASET-P SAFETY IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

Interlude Rolled Tampons in Plastic Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LVivo Software Application

FDA 510(k)

FDA Class 2 ·Radiology

FFRangio System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MATRIX RF APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

FDA 510(k)

FDA Class 2 ·Dental

DORNIR LC-1 CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reverso

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROW FUSION-L

FDA 510(k)

FDA Class 2 ·Orthopedic

CORTEX DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

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

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

DreaMed Advisor Pro

FDA 510(k)

FDA Class 2 ·Clinical Chemistry