DISPOSABLE ECG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOFLIP ECD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VASCUTEK GELSOFT PLUS VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

FDA 510(k)

FDA Class 2 ·Ophthalmic

swiftPro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

NEOSS IMPLANT SYSTEM 03.25

FDA 510(k)

FDA Class 2 ·Dental

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

SpotLight/SpotLight Duo (with DLIR option)

FDA 510(k)

FDA Class 2 ·Radiology

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AutoStrut G2

FDA 510(k)

FDA Class 2 ·Orthopedic

A-V IMPULSE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

WBR XPRESS3.CARDIAC

FDA 510(k)

FDA Class 2 ·Radiology

SWIFT FX NANO

FDA 510(k)

FDA Class 2 ·Anesthesiology

CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Gallant PTCA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hepatica v1 (Hepatica v1.0.0)

FDA 510(k)

FDA Class 2 ·Radiology

FFRangio

FDA 510(k)

FDA Class 2 ·Cardiovascular